Re-evaluation Decision RVD2020-01, Clodinafop-propargyl and Its Associated End-use Products

Pest Management Regulatory Agency
22 January 2020
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2020-1E-PDF (PDF version)

Table of Contents

Re-evaluation Decision

Under the authority of the Pest Control Products Act, all registered pesticides must be regularly re-evaluated by Health Canada’s Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Clodinafop-propargyl is a registered herbicide for use in western Canada on spring and durum wheat. Currently registered products containing clodinafop-propargyl can be found in the Pesticide Label Search and in Appendix I.

The regulatory approach for the re-evaluation of clodinafop-propargyl was first presented in the Proposed Re-evaluation Decision PRVD2018-16, Clodinafop-propargyl and Its Associated End-use Products,Footnote 1 which underwent a 90-day consultation period ending on 26 December 2018. PRVD2018-16 proposed continued registration provided that proposed risk mitigation measures, to protect human health and the environment, are implemented.

Health Canada received comments and information relating to the health assessments. Respondents are listed in Appendix III. These comments are summarized in Appendix II along with the responses by Health Canada. The comments and new data/information did not result in revisions to the risk assessments (see Science Evaluation Update), and did not result in changes to the proposed regulatory decision as described in PRVD2018-16. A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2018-16, and further information used in the re-evaluation decision is listed in Appendix VI of this document.

This document presents the final regulatory decisionFootnote 2 for the re-evaluation of clodinafop-propargyl, including the required risk mitigation measures to protect human health and the environment. All products containing clodinafop-propargyl that are registered in Canada are subject to this re-evaluation decision.

Outcome of Science Evaluation

Clodinafop-propargyl is used in western Canada on spring and durum wheat. It provides effective control of wild oats, which is one of the major weed problems for wheat growers in western Canada.

With respect to human health, the health risks associated with the use of clodinafop-propargyl and associated end-use products are acceptable when these products are used according to the revised label directions.

Based on the available scientific information, risks to the environment were found to be acceptable when clodinafop-propargyl is used according to the revised label directions, which include advisory statements and spray buffer zones.

Regulatory Decision for Clodinafop-propargyl

Health Canada has completed the re-evaluation of clodinafop-propargyl. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing clodinafop-propargyl is acceptable. An evaluation of available scientific information found that uses of clodinafop-propargyl products meet current standards for protection of human health and the environment when used according to revised label directions, which include new mitigation measures. No additional data are required.

Risk Mitigation Measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The revised label statements and/or mitigation measures required, as a result of the re-evaluation of clodinafop-propargyl, are summarized below. Refer to Appendix V for details.

Human Health

To protect workers, homeowners and those entering treated areas from occupational/residential exposure, the following risk-reduction measures are required:

To protect consumers from dietary exposure, the following risk-reduction measures are required:

Environment

To protect the environment, the following risk-reduction measures are required:

Next Steps

To comply with this decision, the required mitigation measures must be implemented on all product labels sold by registrants no later than 24 months after the publication date of this decision document. Refer to Appendix I for details on specific products impacted by this decision.

Other Information

Any person may file a notice of objectionFootnote 3 regarding this decision on clodinafop-propargyl within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA’s Pest Management Information Service by phone (1-800-267-6315) or by e-mail (hc.pmra.info-arla.sc@canada.ca).

The relevant test data on which the decision is based (as referenced in PRVD2018-16 and this document) are available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa). For more information, please contact the PMRA’s Pest Management Information Service.

Science Evaluation Update

1.0 Health Risk Assessment

1.1 Toxicology Assessment for Clodinafop-propargyl

Comments received during the consultation period covered a range of issues pertaining to the toxicology assessment, including: 1) the vascular tumour analysis; 2) the NOAEL/LOAEL (no/lowest observed adverse effects levels) values for several studies; and 3) the choice of point of departure (POD) endpoint, and study selected for the toxicological reference value for the occupational exposure scenarios in PRVD2018-16. Newly submitted data for clodinafop-propargyl included detailed histopathology for the two-generation dietary reproductive toxicity study, as well as historical control (HC) and individual animal data analysis for several key findings in the two-generation dietary reproductive toxicity study, the gavage developmental toxicity study in rats, the 18-month dietary oncogenicity study in mice, and the 90-day dietary study in dogs. In addition, the most recent United States Environmental Protection Agency (USEPA) and European Food Safety Authority (EFSA) assessments were cited to support the comments. Additional scientific rationales addressing the issues noted above were also provided by the registrant. A weight of evidence review was conducted with consideration of all newly submitted information and rationales in the context of previously evaluated data. As such, all relevant parts of the toxicology assessment outlined in PRVD2018-16 were revisited. However, this did not result in a change to the assessment in PRVD2018-16, and, therefore, all Health Canada’s conclusions remain unchanged.

Detailed responses to the comments received are provided in Appendix II. Toxicological reference values are provided in Appendix IV, Table 1.

1.2 Dietary, Occupational and Non-Occupational and Environmental Exposure and Risk Assessments

The dietary, occupational and non-occupational and environmental assessments for clodinafop-propargyl were previously conducted and published in PRVD2018-16. All risks were shown to be acceptable when additional mitigation measures are followed. No comments specific to these assessments were received, therefore, Health Canada’s risk assessments remain unchanged.

2.0 Conclusion of Science Evaluation

Clodinafop-propargyl is a widely used grass herbicide in spring and durum wheat. It provides effective control of wild oats, which is one of the major weed problems for wheat growers across Canada. It can be tank mixed with a wide range of broadleaf herbicides to broaden weed control spectrum and reduce application passes.

With respect to human health and the environment, risks associated with the use of clodinafop-propargyl and associated end-use products are considered to be acceptable when these products are used according to revised label directions.

List of Abbreviations

ADI
acceptable daily intake
a.i.
active ingredient
ASAE
American Society of Agricultural Engineers
AST
aspartate aminotransferase
ARfD
acute reference dose
bw
bodyweight
CAF
composite assessment factor
CARC
Cancer Assessment Review Committee
EFSA
European Food Safety Authority
F1
first generation
F2
second generation
HC
historical control
IPCS
International programme on chemical safety
kg
kilogram
LDT
lowest dose tested
LOAEL
lowest observed adverse effect level
mg
milligram
MOE
margin of exposure
NOAEL
no observed adverse effect level
PMRA
Pest Management Regulatory Agency
PND
postnatal day
PPE
personal protective equipment
PRVD
proposed re-evaluation decision
POD
point of departure
REI
restricted-entry interval
USEPA
United States Environmental Protection Agency

Appendix I Registered Clodinafop-propargyl Products in CanadaTable Footnote 1

Table 1 Products Requiring Label Amendments
Registration Number Marketing Class Registrant Product Name Formulation Type Active ingredient (%, g/L)
29495 Commercial Adama Agricultural Solutions Canada LTD Mana Ladder 240 EC Emulsifiable Concentrate or Emulsion 240 g/L
30428 Commercial Cadillac 240 g/L
32497 Commercial Ladder All In 80 g/L
32539 Commercial Cadillac One 80 g/L
30137 Commercial Albaugh LLC Slam'r Clodinafop Herbicide 240 g/L
31053 Commercial Slam'r Herbicide 240 g/L
29614 Commercial Arysta Lifescience North America, LLC Nextstep NG Herbicide 60 g/L
29299 Commercial Production Agriscience Canada Company Harmony Grass 128 g/L
31689 Commercial Harmony Grass 240 EC Herbicide 240 g/L
29526 Commercial Interprovincial Cooperative Limited Legend A 240 g/L
29711 Commercial Newagco Inc. MPower Aurora® Clodinafop Herbicide 240 g/L
30949 Commercial MPower Aurora-I Clodinafop Herbicide 240 g/L
29172 Commercial Nufarm Agriculture Inc. Signal Herbicide 240 g/L
29962 Commercial Nufarm Clodinafop Herbicide 240 g/L
30168 Commercial Nufarm Signal Herbicide 240 g/L
31434 Commercial Signal F Herbicide 112 g/L
(+ fluoxypyr 217 g/L)
31261 Commercial Farmers Business Network Canada Inc. Foax Herbicide 240 g/L
33323 Commercial FBN Clodinafop 240 g/L
24067 Commercial Syngenta Canada Inc. Horizon 240EC Herbicide 240 g/L
24076 Commercial Horizon 240EC Herbicide (component of horizon herbicide tank mix) 240 g/L
29089 Commercial Horizon NG Herbicide 60 g/L
29855 Commercial Traxos Herbicide 25 g/L
(+ pinoxaden 25 g/L)
30341 Commercial Foothills NG Herbicide 60 g/L
31674 Commercial Traxos®two Grass Component 25 g/L
(+ pinoxaden 25 g/L)
33133 Commercial Agrogill Chemicals PTY LTD Agrogill Clodinafop 240EC 239 g/L
30743 Commercial UPL NA Inc. Current 240 EC Herbicide 240 g/L
31157 Manufacturing Concentrate Current 240 EC MUP Herbicide 240 g/L
29373 Technical Active Adama Agricultural Solutions Canada LTD Mana Clodinafop-Propargyl Technical Dust 97.1%
29425 Technical Active Agrogill Chemicals PTY LTD Clodinafop-propargyl Agrogill Technical Grade Active Ingredient Solid 98.0%
29424 Technical Active Newagco Inc. Newagco Clodinafop-Propargyl Herbicide Technical 95.2%
33168 Technical Active Newagco Clodinafop Herbicide Technical 96.8%
30762 Technical Active Farmers Business Network Canada Inc. Technical Clodinafop Herbicide 96.75%
30218 Technical Active Sinon USA Inc. Clodinafop-propargyl Sinon Technical Active Ingredient 98.0%
27430 Technical Active Syngenta Canada Inc. Clodinafop-propargyl Technical Active Ingredient Dust or Powder 98%
29432 Technical Active UPL NA Inc. UPI Clodinafop-propargyl Technical Herbicide 97.7%
Table Footnote 1

as of 11 October 2019, excluding discontinued products or products with a submission for discontinuation

Return to footnote 1 referrer

Appendix II Comments and Responses

In response to the consultation for the clodinafop-propargyl proposed re-evaluation decision, Health Canada received written comments (respondents’ affiliations listed in Appendix III). These comments were considered during the final decision phase of this re-evaluation. Summarized comments and Health Canada’s responses, are provided below.

1.0 Comments Related to the Health Risk Assessment

1.1 Toxicology

1.1.1a Comment – Vascular Tumours

The registrant provided comments stating that the increased incidence of vascular tumours noted in the high dose female group of the 18-month dietary oncogenicity study in mice was not treatment-related. Their rationale included the following: 1) the tumours were noted in one sex only and at a very low incidence rate; 2) the incidences fell within the HC range, and 3) combining benign (hemangiomas) and malignant (angiosarcoma) incidences across all tissue types is not appropriate from a cancer biology perspective. It was further suggested that Health Canada use the USEPA assessments, particularly the 2006 USEPA cancer assessment review committee (CARC) report, along with numerous cited or submitted (PMRA# 2947056) published articles from the scientific literature to reconsider these tumours as incidental and unrelated to exposure to clodinafop-propargyl.

1.1.1b  Response

Health Canada revisited the incidences of vascular tumours observed in the 18-month dietary oncogenicity study in mice in light of comments, scientific rationales, and HC data. The following reflects the conclusions from the weight of evidence review:

In summary, Health Canada’s conclusion regarding vascular tumours as noted in PRVD2018-16 remains unchanged.

1.1.2a  Comment – Toxicological reference value selected for the short- and intermediate-term dermal and inhalation exposure scenarios

The registrant contested the selection of the offspring NOAEL at the dose level of 0.4 mg/kg bw/day in the two-generation dietary reproductive toxicity study. This dose level was used as the POD for deriving the toxicological reference value for the occupational exposure scenarios in the PRVD2018-16. The registrant requested that Health Canada select the offspring NOAEL and the POD at the next higher dose level of 3.8 mg/kg bw/day for this study, in agreement with the latest USEPA and EFSA assessments.

The registrant also requested that the NOAELs for the 90-day dietary toxicity study in dogs and the gavage developmental toxicity study in rats be revised to higher dose levels and not be used as the POD for deriving the toxicological reference value. To further support their comments, relevant histopathology data, HC data, as well as individual animal data analysis, and other scientific rationales were provided or cited.

1.1.2b  Response

Health Canada revisited the NOAELs selected for each of the three toxicity studies identified by the registrant, and subsequently, the selection of the appropriate study for the short- and intermediate-term dermal and inhalation risk assessments. Each study is discussed separately below.

A. 90-day dietary toxicity study in dogs

In PRVD2018-16, a NOAEL of 0.4 and 1.9 mg/kg bw/day for males and females respectively, was selected for this study. The LOAEL of 8 and 7 mg/kg bw/day in males and females, respectively, was based on decreased cholesterol levels, increased AST activity, and increased incidence of skin lesions noted during the routine examination of the animals.

Based on a review of laboratory-specific HC data submitted following publication of PRVD2018-16, cholesterol and AST activity levels in test animals were judged to be within the HC range at the LOAEL. However, a treatment-related effect in these clinical chemistry parameters was not excluded at the high dose level due to a dose-related trend and a large difference compared to the concurrent control values. A re-examination of the individual animal data in this study and in the 12-month dietary toxicity study in dogs indicated that these lesions were transient in nature, did not persist until necropsy, and were not corroborated by the histopathology results, except at dose levels of approximately 16 mg/kg bw/day in both studies.

Therefore, the NOAEL for the 90-day dietary toxicity study in dogs was revised to 8 and 7 mg/kg bw/day in males and females, respectively. However, this did not change the reference values selected in PRVD2018-16.

B. Developmental toxicity study in rats

A developmental toxicity NOAEL was not established for this study in PRVD2018-16. Instead, a LOAEL was established at the lowest dose tested (LDT) of 5 mg/kg bw/day, based on increased incidences of incomplete or absent ossification and bilateral ureter torsion and distension. The registrant requested that Health Canada revise the developmental toxicity NOAEL to the mid-dose level of 40 mg/kg bw/day because the above-noted developmental findings fell within their respective HC ranges. This supporting HC data were not available for PRVD2018-16. Additional comments, along with additional cited or submitted scientific rationales and journal articles, suggested that the incomplete or absent ossification findings, as well as bilateral ureter torsion and distension findings, did not constitute serious developmental effects.

Following a weight of evidence review of comments and data submitted, including the recent evaluations from EFSA and the USEPA, as well as published scientific rationales, Health Canada reached the following conclusions:

Based on the considerations noted above, the LOAEL determined for this study in PRVD2018-16 remains unchanged.

C. Two-generation reproductive toxicity study in rats

An offspring NOAEL of 0.4 mg/kg bw/day was selected for this study in PRVD2018-16. The LOAEL of 3.8 mg/kg bw/day was based on decreased body weight in the F1 pups and increased incidence of unilateral and/or bilateral renal pelvis dilatation in the F2 pups. The registrant stated that, at the dose level of 3.8 mg/kg bw/day, the decrease in body weight was slight and the incidence of dilated renal pelvis fell within the newly submitted HC range. Further comments and the associated individual animal data analysis conducted by the registrant suggested that data from a single litter at the dose level of 3.8 mg/kg bw/day was a statistically significant outlier and should be excluded from the pup body weight data analysis. Significant mortality and reduction in the body weight of pups in this single litter, as well as body weight loss in the maternal animal, provided further justification for this exclusion.

Following a weight of evidence review of comments and data submitted, including the recent evaluations from EFSA and USEPA, Health Canada reached the following conclusions:

Based on the considerations noted above, the LOAEL determined for this study in PRVD2018-16 remains unchanged. Thus, as indicated in PRVD2018-16, the LOAEL is 3.8 mg/kg bw/day based on decreased pup body weight in F1 and increased incidence of dilated unilateral renal pelvis in the F2 pups.

Conclusion

The toxicological reference value of 0.4 mg/kg bw/day, with a target MOE of 100, which was selected for the short- and intermediate-term occupational exposure scenario in PRVD2018-16, was re-confirmed.

Appendix III List of Respondents to PRVD2018-16

List of respondents' affiliations in terms of comments submitted in response to PRVD2018-16
Category Respondent
Registrant Syngenta Canada Inc.

Appendix IV Toxicological Reference Values

Table 1 Toxicological Reference Values for Use in Health Risk Assessment for Clodinafop-propargyl
Exposure Scenario Study Point of Departure and Endpoint CAF or target MOEFootnote 1
ARfD (all populations) Developmental neurotoxicity study in rats NOAEL = 9 mg/kg bw/day
Decreased auditory startle reflex and changes in brain morphometrics
300
PCPA factor = threefold
-- -- ARfD = 0.03 mg/kg bw --
Repeated Dietary (all populations) Two-year dietary chronic toxicity/ carcinogenicity study in rats NOAEL = 0.3 mg/kg bw/day
Liver toxicity (elevated enzyme activities, increased weight and histopathological findings) and kidney toxicity (chronic progressive nephropathy, and tubular pigmentation)
100
-- -- ADI = 0.003 mg/kg bw/day --
Short- and Intermediate-term dermal and inhalation Two-generation reproductive toxicity study in rats NOAEL = 0.4 mg/kg bw/day
Increased incidence of unilateral dilatation of the renal pelvis in F2 pups and decreased pup (and litter) body weight on PND 4–21 in F1
100
Cancer -- q1* value = 0.0302 (mg/kg bw/day)-1 for rat prostate adenomas and carcinomas (combined) which is also protective of vascular tumours --
Table Footnote 1

CAF (composite assessment factor) refers to a total of uncertainty and Pest Control Product Act factor (PCPA factor) for dietary assessments; MOE refers to a target MOE for occupational assessments

Return to footnote 1 referrer

Appendix V Label Amendments for Products Containing Clodinafop propargyl

Information on labels of currently registered products should not be removed unless it contradicts the label statements provided below.

1. Label statements for Technical Products

On the primary panel, remove “GUARANTEE” and replace with “ACTIVE INGREDIENT”.

Before STORAGE section, add “ENVIRONMENTAL HAZARDS” and the following statements:

2. Label statements for Commercial and Agricultural class products

Precautions

The following label statements are to be added to the PRECAUTIONS section of all commercial end-use products, unless already present:

“Apply only when the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools and recreational areas is minimal. Take into consideration wind speed, wind direction, temperature inversions, application equipment and sprayer settings.”

Personal Protective Equipment

Label statements must be amended (or added) to include the following directions to the appropriate labels, unless the current label mitigation is more restrictive:

  1. Add the following text:

    “If mixing and loading more than 15 kg a.i. in a day, workers must use a closed mixing/loading system.”

  2. Remove:

    “Wear coveralls or long sleeved shirt and long pants, chemical resistant gloves, and goggles when mixing loading or during equipment clean up or repair.”

    Replace with:
    “During mixing, loading, clean-up, repair and when applying by groundboom, workers must wear coveralls over long-sleeved shirt and long pants, shoes and socks, goggles, and chemical-resistant gloves. When applying by aerial application, pilots must wear long-sleeved shirt and long pants”

  3. Remove:

    “During mixing, loading, application, spill clean-up, and sprayer clean-up, maintenance or repair, wear a long-sleeved shirt, long pants and chemical resistant gloves.”

    Replace with:
    “During mixing, loading, clean-up, repair and when applying by groundboom, workers must wear coveralls over long-sleeved shirt and long pants, shoes and socks, and chemical-resistant gloves. When applying by aerial application, pilots must wear long-sleeved shirt and long pants.”

Restricted-Entry Interval

Label statements must be amended (or added) to include the following directions to the appropriate labels, unless the current label mitigation is more restrictive:

"DO NOT enter or allow worker entry into treated areas during the restricted-entry interval (REI) of 12 hours."

Directions For Use

Current label restrictions for grazing of livestock on treated crops must be amended for the appropriate labels as follows:

  1. Remove:
    "Observe a minimum of three (3) days before grazing livestock on treated crops"

    Replace with:
    "Observe a minimum pre-harvest interval of 60 days after treatment for grain and straw and of 30 days after treatment for hay. Observe a minimum of seven (7) days before grazing livestock on treated crops".

Add the following to ENVIRONMENTAL HAZARDS:

Add to DIRECTIONS FOR USE

The following statements are required for all agricultural and commercial pesticide products:

Remove the following statement under the STORAGE section of the labels for the end-use products:

“Store the product in closed original container in a well-ventilated room. Keep out of reach of children, unauthorized persons and animals. To prevent contamination store this product away from food, feed, and fertilizer.”

And replace it with the following statement:

“To prevent contamination store this product away from food or feed.”

The following statement is required under the ENVIRONMENTAL PRECAUTIONS section of the label for all clodinafop-propargyl end-use products that contain aromatic petroleum distillates (Products that do not contain petroleum distillates are Reg. Nos. 29089, 29614, 30341 and 30426):

“This product contains an active ingredient and aromatic petroleum distillates which are toxic to aquatic organisms.”

Add to ENVIRONMENTAL PRECAUTIONS:

TOXIC to aquatic organisms and non-target terrestrial plants. Observe buffer zones specified under DIRECTIONS FOR USE.

Add to DIRECTIONS FOR USE:

Field sprayer application: DO NOT apply during periods of dead calm. Avoid application of this product when winds are gusty. DO NOT apply with spray droplets smaller than the American Society of Agricultural Engineers (ASAE S572.1) medium classification. Boom height must be 60 cm or less above the crop or ground.

Aerial application: DO NOT apply during periods of dead calm. Avoid application of this product when winds are gusty. DO NOT apply when wind speed is greater than 16 km/h at flying height at the site of application. DO NOT apply with spray droplets smaller than the American Society of Agricultural Engineers (ASAE S572.1) coarse classification. Reduce drift caused by turbulent wingtip vortices. The nozzle distribution along the spray boom length MUST NOT exceed 65% of the wing- or rotorspan.

Buffer zones:

Spot treatments using hand-held equipment DO NOT require a buffer zone.

The buffer zones specified in the table below are required between the point of direct application and the closest downwind edge of sensitive terrestrial habitats (such as grasslands, forested areas, shelter belts, woodlots, hedgerows, riparian areas and shrublands) and sensitive freshwater habitats (such as lakes, rivers, sloughs, ponds, prairie potholes, creeks, marshes, streams, reservoirs and wetlands).

Method of application Crop Buffer Zones (metres) Required for the Protection of:
Freshwater Habitat of Depths: Terrestrial Habitat:
Less than 1 m Greater than 1 m
Field sprayer Spring and durum wheat 1 0 1
Aerial Spring and durum wheat
(55.2–70.2 g a.i./ha)
Fixed wing 1 0 20
Rotary wing 1 0 20
Spring and durum wheat (30 g a.i./ha)
(PCP# 29855 and 31674)
Fixed wing 1 0 15
Rotary wing 1 0 15

For tank mixes, consult the labels of the tank-mix partners and observe the largest (most restrictive) buffer zone of the products involved in the tank mixture and apply using the coarsest spray (ASAE) category indicated on the labels for those tank mix partners.

The buffer zones for this product can be modified based on weather conditions and spray equipment configuration by accessing the Buffer Zone Calculator in the Pesticides portion of Canada.ca.

Appendix VI References Considered Following Publication of RVD2018-16

Note that the following includes only references that were not previously considered in PRVD2018-16.

A. Information Considered in the Updated Toxicological Assessment

List of Studies/Information Submitted by Registrant
PMRA Document Number Title
2947054 2018, Correspondence – Re-evaluation of Clodinafop-propargyl (Ref No. 2012-1629), Proposed Re-evaluation Decision for Clodinafop-propargyl (PRVD2018-16).
2947055 2018, Response PMRA Sub. No. 2012-1629: Re-evaluation of Clodinafop-propargyl – Comments related to PMRA# 1123424, 1123353, 1158474, DACO: 4.4.3
2947056 2013, Pathogenesis of human hemangiosarcomas and hemangiomas, DACO: 4.4.3
2947057 2018, Clodinafop-propargyl, Evaluation of the NOAEL for Offspring toxicity in the rat two-generation reproduction study – Response to PMRA PRVD2018-16, DACO: 4.5.1
2947058 1994, Addendum histopathology – two-generation oral reproduction toxicity study in rat, DACO: 4.5.1
2947059 2018, Clodinafop-propargyl, Evaluation of the observed effect level for developmental toxicity in the rat prenatal developmental study – Response to PMRA PRVD2018-16, DACO: 4.5.2
2947060 2011, Significance, reliability, and interpretation of developmental and reproductive toxicity study findings. In: Developmental and reproductive toxicology: a practical approach, DACO: 4.5.2
2947061 2007, Review article: Interpretation of Skeletal variations for human risk assessment: delayed ossification and wavy ribs, DACO: 4.5.2
2947062 2010, Altered health outcomes in adult offspring of Sprague Dawley and Wistar rats undernourished during early or late pregnancy, DACO: 4.5.2
2947063 2017, Review article: species differences in renal development and associated developmental nephrotoxicity, DACO: 4.5.2
2947064 1994, Practical guidance for evaluating and interpreting developmental toxicity tests, DACO: 4.5.2
2947065 2014, Review article: relationship between bent long bones, bent scapulae, and wavy ribs: malformations or variations, DACO: 4.5.2
2947066 1998, Upper urinary tract obstruction: experimental and clinical aspects, DACO: 4.5.2
2947067 2001, Harmonisation of rat fetal skeletal terminology and classification. Report of the third workshop on the terminology in developmental toxicology Berlin, DACO: 4.5.2
2947068 2011, Comparative gestational milestones in vertebrate development, DACO: 4.5.2
2947069 2018, Clodinafop-propargyl – Assessment of NOAEL values for intermediate-term toxicology studies assessment, DACO: 4.8
2947070 2002, Recognition of adverse and nonadverse effects in toxicity studies, DACO: 4.8

Additional Information Considered

Published Information
PMRA Document Number Title
3019737 2018, EFSA (European food safety authority). Conclusion on pesticides peer review. Peer review of the pesticide risk assessment of the active substance clodinafop-propargyl, DACO: 12.5
3019738 2017, USEPA (United States Environmental Protection Agency). Human health draft risk assessment for registration review, DACO: 12.5
3019739 R. Solecki et al. Harmonization of rat fetal external and visceral terminology and classification. Report of the fourth workshop on the terminology in developmental toxicology, Berlin 18-20 April 2002. Reproductive toxicology 17 (2003) 625-637.
3019740 S.L. Makris et al. Terminology of developmental abnormalities in common laboratory mammals (version 2). Reproductive toxicology 28 (2009) 371-434.

Footnotes

Footnote 1

"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

Return to footnote 1 referrer

Footnote 2

"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

Return to footnote 2 referrer

Footnote 3

As per subsection 35(1) of the Pest Control Products Act.

Return to footnote 3 referrer

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