Certain substances on the Domestic Substances List used primarily as pharmaceuticals fact sheet

What are they?

How are they used?

  • These 28 substances are used primarily as pharmaceuticals for humans and animals, and they may be used in medical research.
  • In addition to its pharmaceutical use, warfarin is also used as a rodenticide.

Why did the Government of Canada assess them?

  • Prior to the assessments, these 28 substances were identified as priorities as they either met the categorization criteria of the Domestic Substances List and/or were associated with a potential concern to the environment or to human health.
  • Most of the 28 substances have been previously assessed under the Food and Drugs Act for their safety, effectiveness and quality as pharmaceuticals. However, their assessments did not evaluate potential concerns to the environment or human health resulting from the release of these substances to the environment.
  • Warfarin was also assessed under the Pest Control Product Act for use as a rodenticide.
  • These substances have been assessed to determine if small amounts in the environment resulting from their use, manufacturing, production and disposal posed a potential concern to the environment and to human health.

How are Canadians exposed to them?

  • Exposure of the general population of Canada to these 28 substances via environmental media is expected to be low.

How are they released to the environment?

  • These 28 substances may be released to the environment primarily through wastewater resulting from their use, manufacture, formulation, and/or improper disposal. They may be present in surface water as a result of industrial or down-the-drain releases.

What are the results of the assessment?

  • The Government of Canada has conducted a science-based evaluation of these 28 substances, called a screening assessment.
  • Screening assessments address potential for harm to the general population in Canada and the environment.
  • Results of the final screening assessments indicate that 23 of the 28 substances are not expected to remain in the environment for a long time or accumulate in organisms. Although tamoxifen, doxorubicin, etoposide, cyclosporin A and cyclosporin E may remain in the environment for a long time, they are not expected to accumulate in organisms.
  • Furthermore, the quantity of these 28 substances that may be released to the environment is below the level expected to cause harm to organisms.
  • The Government of Canada has therefore concluded that these 28 substances are not entering the environment at levels that constitute a danger to the environment.
  • The Government of Canada has also concluded that these 28 substances are not harmful to human health at current levels of exposure based on releases of these substances into the environment.

What is the Government of Canada doing?

  • The Government of Canada published the five final screening assessments on these 28 substances on February 21, 2015.
  • Based on the conclusion of the screening assessment, the Government of Canada has concluded that no further action be taken on any of the 28 substances.
  • Read more information about , including information on the screening assessments.

What can Canadians do?

  • The health risks associated with a chemical depend on the hazard (its potential to cause health effects) and the dose (the amount of chemical to which you are exposed). These 28 substances are not a concern for the environment or human health at current levels of exposure from the environment.
  • As a general precaution, Canadians are reminded when using any product to carefully follow any safety warnings and directions.
  • Canadians are encouraged to dispose of unused and expired medication in an environmentally safe manner. Pharmaceutical take-back programs exist in many provinces and territories. For more details, check with your local pharmacy.
Twenty eight substances used primarily as pharmaceuticals assessed by the Government of Canada
CAS RN DSL Name Common Pharmaceutical Name
50-06-6 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl- Phenobarbital
50-18-0 2H-1,3,2-Oxazaphosphorin-2-amine, N,N-bis(2-chloroethyl)tetrahydro-, 2-oxide Cyclophosphamide
55-86-7 Ethanamine, 2-chloro-N-(2-chloroethyl)-N-methyl-, hydrochloride Mechlorethamine
55-98-1 1,4-Butanediol, dimethanesulfonate Busulfan
56-75-7 Acetamide, 2,2-dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]-, [R-(R,R)]- Chloramphenicol
57-41-0 2,4-Imidazolidinedione, 5,5-diphenyl- Phenytoin
68-22-4 19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17a)- Norethindrone
71-58-9 Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6a)- Medroxyprogesterone
81-81-2 2H-1-Benzopyran-2-one, 4-hydroxy-3-(3-oxo-1-phenylbutyl)- Warfarin
126-07-8 Spiro[benzofuran-2(3H),1'-[2]cyclohexene]-3,4'-dione, 7-chloro-2',4,6-trimethoxy-6'-methyl-, (1'S-trans)- Griseofulvin
148-82-3 L-Phenylalanine, 4-[bis(2-chloroethyl)amino]- Melphalan
154-93-8 Urea, N,N'-bis(2-chloroethyl)-N-nitroso- Carmustine
305-03-3 Benzenebutanoic acid, 4-[bis(2-chloroethyl)amino]- Chlorambucil
443-48-1 1H-Imidazole-1-ethanol, 2-methyl-5-nitro- Metronidazole
446-86-6 1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]- Azathioprine
604-75-1 2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl- Oxazepam
7481-89-2 Cytidine, 2',3'-dideoxy- Zalcitabine
10540-29-1 Ethanamine, 2-[4-[(1Z)-1,2-diphenyl-1-butenyl]phenoxy]-N,N-dimethyl- Tamoxifen
13010-47-4 Urea, N-(2-chloroethyl)-N'-cyclohexyl-N-nitroso- Lomustine
18883-66-4 D-Glucose, 2-deoxy-2-[[(methylnitrosoamino)carbonyl]amino]- Streptozocin
20830-81-3 5,12-Naphthacenedione, 8-acetyl-10-[(3-amino-2,3,6-trideoxy-a-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S,10S)- Daunorubicin
23214-92-8 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-a-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8S-cis)- Doxorubicin
29767-20-2 Furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one, 5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)-9-[[4,6-O-[(R)-2-thienylmethylene]-ß-D-glucopyranosyl]oxy]-, (5R,5aR,8aR,9S)- Teniposide
30516-87-1 Thymidine, 3'-azido-3'-deoxy- Zidovudine
33419-42-0 Furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one, 9-[[4,6-O-(1R)-ethylidene-ß-D-glucopyranosyl]oxy]-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)-, (5R,5aR,8aR,9S)- Etoposide
51264-14-3 Methanesulfonamide, N-[4-(9-acridinylamino)-3-methoxyphenyl]- Amsacrine
59865-13-3 Cyclosporin A Cyclosporin A
63798-73-2 Cyclosporin E Cyclosporin E
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