Significant new activity requirements on the Domestic Substances List

Column 1 Substance	Column 2 Significant New Activities, Information to be Provided, Period for Assessment and Classes of Persons
1####-##-# S'	1 Subsection 81(3) of the Act applies with respect to the substance <Substance Name> in respect of any activity involving the substance, if the total quantity of the substance involved across all activities in a calendar year is greater than 100 kg. 2 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the significant new activity begins: (a) the information specified in sections 1 to 7 of Part 1 of Schedule 1; and (b) the information specified in sections 1 to 4 of Part 3 of that Schedule. 3 The information provided under section 2 is to be assessed within 90 days after the day on which it is received by the Minister.
2####-##-# N-S	1 Subsection 81(3) of the Act applies with respect to the substance <Substance Name> in respect of any activity involving the substance, if the total quantity of the substance involved across all activities in a calendar year is greater than 1 000 kg. 2 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the significant new activity begins: (a) the information specified in sections 1 to 9 of Part 1 of Schedule 1; (b) the information specified in section 53 of Part 2 of that Schedule; and (c) the information specified in sections 1 to 4 of Part 3 of that Schedule. 3 The information provided under section 2 is to be assessed within 90 days after the day on which it is received by the Minister.

Significant new activity

# (1) Subsection 81(3) of the Act applies with respect to a substance set out in the table to this subsection in respect of any activity involving the substance if the total quantity of the substance involved across all activities in a calendar year is greater than 100 kg.

Information to be provided

(2) For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the significant new activity begins:

(a) the information specified in sections 1 to 7 of Part 1 of Schedule 1;
(b) the information specified in section 9 of Part 2 of that Schedule; and
(c) the information specified in sections 1 to 4 of Part 3 of that Schedule.

Period for assessment

(3) The information provided under subsection (2) is to be assessed within 90 days after the day on which it is received by the Minister.

1 A description of the significant new activity in relation to the substance.

2 The quantity of the substance that is anticipated to be used, manufactured or imported in a calendar year.

3 If known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the anticipated quantity by site.

4 The chemical name of the substance, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service.

5 The trade names of the substance and the synonyms of its chemical name, if known.

6 The Chemical Abstracts Service registry number of the substance, if such a number can be assigned.

7 A safety data sheet for the substance, if available.

8 The following information in respect of the substance:

(a) its molecular formula;

(b) its structural formula;

(c) its gram molecular weight;

(d) the degree of purity in its technical grade composition, if applicable;

(e) the known impurities in its technical grade composition and their concentration by weight; and

(f) any additives, stabilizers and solvents present when it is studied and their concentration by weight.

9 The composition of the substance, including the constituents — such as monomers and other reactants, additives, stabilizers and solvents — that are present when the substance is studied, as well as the Chemical Abstracts Service registry number, if such a number can be assigned, and concentration by weight of each constituent.

10 The reaction scheme for the substance.

11 The following information in respect of the product and, if known, any end-use products that contain the substance:

(a) a description of the product and end-use products, the intended use and method of application of the product and end-use products and the function of the substance in the product and end-use products;

(b) the concentration of the substance in the product and end-use products;

(c) the quantity of the product and end-use products that the person proposing the significant new activity expects to sell in Canada in a calendar year; and

(d) a statement as to whether the public is anticipated to be significantly exposed to the substance in the product or end-use products — taking into account factors including the concentration of the substance in the product or end use products, the duration, frequency and circumstances of exposure, whether the substance is released intentionally or not from the product or end-use products during use, and factors that may limit direct human exposure — and, if the public is not anticipated to be significantly exposed, information substantiating the statement.

12 The following information in respect of exposure to the substance:

(a) the historical uses of the substance and its anticipated uses;

(b) a description of the recommended methods for destroying or disposing of the substance;

(c) a description of the expected modes of transportation and storage of the substance;

(d) the size and type of container to be used for the transporting and storing the substance;

(e) an indication of the components of the environment (water, air and land) into which the substance is anticipated to be released, the quantity of the substance anticipated to be released into each of those components and, if the substance is anticipated to be released into water or land, a description of the receiving body of water or type of land;

(f) the quantity of the substance that is anticipated to be released into municipal wastewater treatment systems;

(g) any factors that may limit environmental exposure to the substance;

(h) a statement as to whether the substance is anticipated to be released into the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and, if the quantity released is anticipated to be less than or equal to 3 kg per day, per site, information substantiating the statement;

(i) a statement as to whether the substance will be used in products intended for use by or for children; and

(j) the anticipated degree of direct human exposure to the substance, including the concentration to which humans will be directly exposed, the duration and frequency of the exposure, the circumstances leading to the exposure and factors that may limit the exposure.

13 The following information in respect of the substance:

(a) its physical state; and

(b) a statement as to whether it is formulated for dispersal in water.

14 (1) A flow diagram of the overall process and the steps involved in the significant new activity that result or may result in the entry or release of the substance into the environment, including the use of holding tanks, process tanks and distillation towers, if applicable.

(2) A description of each of the steps referred to in subsection (1), the quantities and concentrations that are or may be released at each step, the physical form of the substance for each location where the substance will or may be released and, if applicable, the anticipated frequency, duration and rate of release.

15 A description of the manufacturing process, including descriptions of the reactants used to produce the substance, the points of entry of all reactants, the reaction stoichiometry, the chemical conversions, the points of release of the substance, the processes to eliminate environmental release of the substance and the nature (batch or continuous) and scale of the process.

16 A description of the waste management practices to be implemented to prevent or minimize the release of the substance at the facility, if any, where the significant new activity will be conducted and other information related to waste management, including

(a) the quantity of the substance, in effluents and emissions, that is anticipated to be released into the environment, including average and peak concentrations;

(b) if the substance is anticipated to be released into a municipal wastewater system, the name and address of the municipal wastewater treatment facility, the name of the receiving body of water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released at that location per day, expressed in kilograms;

(c) if the substance is anticipated to be released directly into surface waters, the name of the receiving body of water and the location of the point of release, as well as the total quantity of the substance that is anticipated to be released at that location per day, expressed in kilograms; and

(d) if waste containing the substance is anticipated to be treated on-site, a description of the treatment system, the total quantity of the substance that is anticipated to be released per year, expressed in kilograms, the percentage of the substance to be removed from the waste, the name of the receiving body of water and the location of the point of release.

17 A description of the degree to which the significant new activity will result in dispersal of the substance or, if the substance will not be dispersed, a description of how it will be contained or consumed.

18 A description of the methods to be used by the person proposing the significant new activity to destroy or dispose of the substance, as well as the following information:

(a) the total quantity of the substance to be destroyed or disposed of by each method per year, expressed in kilograms;

(b) a description of the types of waste that will contain the substance, the anticipated quantity of each type of waste to be produced per year, expressed in kilograms, the classification of the waste under provincial law and the site of destruction or disposal of the waste; and

(c) a description of the methods to be used to treat and dispose of containers that have been used to transport and store the substance.

19 An estimate of the daily and annual quantities of the substance that are anticipated to be released as fugitive emissions from all steps involved in the significant new activity.

1 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 107: Partition Coefficient (n-octanol/water): Shake Flask Method of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

2 (1) The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 111: Hydrolysis as a Function of pH of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

(2) The products of the hydrolysis, if known.

3 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 117: Partition Coefficient (n-octanol/water), HPLC Method of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

4 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 120: Solution/Extraction Behaviour of Polymers in Water of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

5 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 121: Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

6 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

7 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

8 The data and a report from a study in respect of the substance, conducted in accordance with the methodology described in Test No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials of the OECD Guidelines, Section 1, that is current at the time the study is conducted.

9 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

10 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 202: Daphnia sp. Acute Immobilisation Test of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

11 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 203: Fish, Acute Toxicity Test of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

12 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No 210: Fish Early-life Stage Toxicity Test of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

13 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 211: Daphnia magna Reproduction Test of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

14 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

15 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 225: Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

16 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 229: Fish Short Term Reproduction Assay of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

17 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 233: Sediment Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment of the OECD Guidelines, Section 2, that is current at the time the study is conducted

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

18 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 234: Fish Sexual Development Test of the OECD Guidelines, Section 2, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

19 (1) The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 301: Ready Biodegradability of the OECD Guidelines, Section 3, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted

(2) The products of biodegradation, if known.

20 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 305: Bioaccumulation in Fish: Aqueous and Dietary Exposure of the OECD Guidelines, Section 3, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

21 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 402: Acute Dermal Toxicity of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

22 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 403: Acute Inhalation Toxicity of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

23 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 404: Acute Dermal Irritation/Corrosion of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

24 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 406: Skin Sensitisation of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

25 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

26 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 410: Repeated Dose Dermal Toxicity: 21/28-day Study of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

27 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 411: Subchronic Dermal Toxicity: 90-day Study of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

28 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 412: Subacute Inhalation Toxicity: 28-Day Study of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

29 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 413: Subchronic Inhalation Toxicity: 90-day Study of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

30 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 414: Prenatal Development Toxicity Study of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

31 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 415: One-Generation Reproduction Toxicity Study of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

32 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 416: Two-Generation Reproduction Toxicity of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

33 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 417: Toxicokinetics of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

34 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 420: Acute Oral Toxicity - Fixed Dose Procedure of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

35 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 421: Reproduction/Developmental Toxicity Screening Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

36 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

37 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 423: Acute Oral toxicity - Acute Toxic Class Method of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

38 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

39 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 427: Skin Absorption: In Vivo Method of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

40 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 428: Skin Absorption: in Vitro Method of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

41 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 429: Skin Sensitization: Local Lymph Node Assay of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

42 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER) of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

43 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

44 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 436: Acute Inhalation Toxicity – Acute Toxic Class Method of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

45 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

46 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 451: Carcinogenicity Studies of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

47 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 471: Bacterial Reverse Mutation Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

48 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 473: In Vitro Mammalian Chromosomal Aberration Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

49 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 474: Mammalian Erythrocyte Micronucleus Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

50 (1) The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 475: Mammalian Bone Marrow Chromosomal Aberration Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) Data substantiating that the tissue investigated was exposed to the substance or its metabolites.

51 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests using the Hprt and xprt genes of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

52 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 487: In Vitro Mammalian Cell Micronucleus Test of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

53 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

54 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 489: In Vivo Mammalian Alkaline Comet Assay of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

55 The data and a report from a study in respect of the substance, conducted in accordance with

(a) the methodology described in Test No. 490: In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene of the OECD Guidelines, Section 4, that is current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

56 (1) The data and a report from a ready biodegradation study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The products of biodegradation, if known.

57 The data and a report from an acute fish, daphnia or algae toxicity study in respect of the substance — with the type of study being selected on the basis of the most sensitive of those species — conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

58 The data and a report from an acute fish toxicity study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

59 The data and a report from an acute daphnia toxicity study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

60 The data and a report from an acute algae toxicity study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

61 (1) The data and a report from an oral, dermal or inhalation acute mammalian toxicity study in respect of the substance — with the type of study being selected on the basis of the most significant route of potential human exposure to the substance — conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

62 (1) The data and a report from an oral acute mammalian toxicity study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

63 (1) The data and a report from a dermal acute mammalian toxicity study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

64 (1) The data and a report from an inhalation acute mammalian toxicity study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

65 (1) The data and a report from an oral, dermal or inhalation repeated-dose mammalian toxicity study of at least 28 days in respect of the substance — with the type of study being selected on the basis of the most significant route of potential human exposure to the substance — conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

66 (1) The data and a report from an oral repeated-dose mammalian toxicity study of at least 28 days in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

67 (1) The data and a report from a dermal repeated dose mammalian toxicity study of at least 28 days in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

68 (1) The data and a report from an inhalation repeated-dose mammalian toxicity study of at least 28 days in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

69 (1) The data and a report from a skin irritation study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

70 (1) The data and a report from a skin sensitization study in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

71 The data and a report from an in vitro gene mutation study in respect of the substance, with and without metabolic activation, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

72 The data and a report from an in vitro mammalian chromosomal aberration study in respect of the substance, with and without metabolic activation, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

73 (1) The data and a report from an in vivo mammalian chromosomal aberration study, gene mutation study or other mutagenicity study that permits an assessment of in vivo mutagenicity in respect of the substance, conducted in accordance with

(a) a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

(2) The following information in respect of the study:

(a) the number of animals tested and the age, sex, species, strain and source of each animal;

(b) the route by which and manner in which the substance is administered and the conditions under which the study is conducted; and

(c) the dose of the substance, the vehicle by means of which the substance is administered and the concentration of the substance in the vehicle.

(3) Data substantiating that the tissue investigated was exposed to the substance or its metabolites.

74 The following data and a report from a study in respect of the substance, conducted in accordance with a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted:

(a) the melting point of the substance or the temperature at which it decomposes

(i) expressed in degrees Celsius, if the melting point or temperature is − 25°C or greater but not greater than 300°C, or

(ii) expressed as “less than − 25°C” or “greater than 300°C”, as appropriate, in any other case;

(b) the boiling point of the substance or the temperature at which it decomposes

(i) expressed in degrees Celsius, if the boiling point or temperature is − 50°C or greater but not greater than 300°C, or

(ii) expressed as “less than − 50°C” or “greater than 300°C”, as appropriate, in any other case;

(c) the density of the substance; and

(d) the vapour pressure of the substance, if it has a standard boiling point of 0°C or greater.

75 The following data and a report from a study in respect of the substance, conducted in accordance with a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted:

(a) the water solubility of the substance; and

(b) a spectral characterization of the substance using infrared, ultraviolet, mass or nuclear magnetic resonance, as appropriate.

76 The following data and a report from a study in respect of the substance, conducted in accordance with a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted:

(a) the octanol-water partition coefficient of the substance;

(b) adsorption-desorption screening test data; and

(c) the hydrolysis rate of the substance as a function of pH and, if known, the products of the hydrolysis.

77 The following data and a report from a study in respect of the substance, conducted in accordance with a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted:

(a) the number average molecular weight of the substance;

(b) the maximum concentrations, expressed as a percentage, of all residual constituents having molecular weights of less than 500 daltons and of all residual constituents having molecular weights of less than 1 000 daltons; and

(c) the water extractability of the substance measured at

(i) pH 7, in the case of anionic and neutral substances,

(ii) pH 2 and 7, in the case of cationic substances, or

(iii) pH 2, 7 and 9, in the case of amphoteric substances.

78 The following data and a report from a study in respect of the substance, conducted in accordance with a methodology that is consistent with the conditions and procedures set out in any of the OECD Guidelines that are relevant to the study and current at the time the study is conducted:

(a) the primary and secondary particle size distributions of the substance and the analytical data that is necessary to determine those distributions; and

(b) the agglomeration or aggregation state, shape, surface area, surface functionalization and surface charge of the substance, and the analytical data that is necessary to determine those properties.

79 The data and a report from a study in respect of the substance, conducted in accordance with

(a) report EPS 1/RM/32, Biological Test Method: Test for Survival and Growth in Sediment Using Larvae of Freshwater Midges (Chironomus tentans or Chironomus riparius), published by Environment Canada in December 1997; and

(b) the OECD principles of good laboratory practice that are current at the time the study is conducted.

1 All other information or test data in respect of the substance that is in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permits the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance.

2 The name of every other government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance — as well as the department’s or agency’s file number, if known — and, if any, the outcome of the department’s or agency’s assessment and the risk management actions that the department or agency has imposed in relation to the substance.

3 Contact information for the person proposing the significant new activity — specifically, their name, civic and postal addresses, telephone number and, if any, fax number and email address — and, if they are not resident in Canada, for the person resident in Canada who is authorized to act on their behalf.

4 A certification that the information provided to the Minister is accurate and complete, dated and signed by the person proposing the significant new activity or, if they are not resident in Canada, by the person resident in Canada who is authorized to act on their behalf.