N-Nitrosodimethylamine

See Guidance on How To Read Table 3.1

Chemical Name N-Nitrosodimethylamine
CAS RN 62-75-9
Assessment Initiative/Publication Name Priority Substances List 2: N-Nitrosodimethylamine (NDMA)
Report Publication Type Priority Substances List Assessment Report
Assessment Date
2001 September

Assessment Conclusion under Canadian Environmental Protection Act, 1999, Section 64

(c) [constitutes] or may constitute a danger in Canada to human life or health

Please note that State of Science reports never conclude under section 64, CEPA 1999 (see Report Publication Type).

Ecological Endocrine-Related Effects based on Information as presented in Assessment

No—endocrine-related effects data were not considered for human health or the environment based solely on the information presented in the report for that substance (as listed in CAS RN).

This information is considered up to the cut-off date identified in each report for information gathering.

Ecological Endocrine-Related Effect(s) Observed

not applicable

This provides the endocrine-related effects data for human health or environment at the time of the assessment. Text is as stated in the report (i.e., text is verbatim)

Ecological Endocrine-Related Effects Study (Author/Title/Year)

not applicable

These are the corresponding references for the endocrine-related effects data at the time of the assessment (Ecological Endocrine-Related Effect(s) Observed) for human health or environment. Text is as stated in the report (i.e., text is verbatim)

Substance declared Ecological s.64a because Endocrine-Related Effects as ONE of MANY Lines of Evidence

Not Applicable—the substance was not identified to have endocrine-related effects data (see Ecological Endocrine-Related Effects based on Information as presented in Assessment) or a section 64 conclusion was not provided if a State of Science report was the publication type (see Report Publication Type), or the substance was found to not meet the criteria under section 64 (see Assessment Conclusion under Canadian Environmental Protection Act, 1999, Section 64)

Human Health Endocrine-Related Effect(s) based on Information as presented in Assessment

Maybe—there is uncertainty whether endocrine disruption is the primary mechanism(s) of action resulting in the identified endocrine-related effects based on the information presented in the report.

This information is considered up to the cut-off date identified in each report for information gathering.

Human Health Endocrine-Related Endpoint(s) Observed

a) testicullar damage (necrosis or degeneration of the seminiferous epithelium) b) incidence of liver and Leydig cell tumours c)For some other sites (i.e., pituitary and thyroid in males, and pituitary, uterus, thymus and mammary tissue in females), the incidence of tumours declined with increasing exposure to NDMA d) Clastogenic effects in spermatids e) Evidence of genotoxicity been observed in the offspring of hamsters f) DNA damage in thymus, and sperm

This provides the endocrine-related effects data for human health or environment at the time of the assessment. Text is as stated in the report (i.e., text is verbatim)

Human Health Endocrine-Related Effects Study (Author/Title/Year)

a) Hard and Butler/ Toxicity of dimethylnitrosamine for the rat testis./1970b. b) Terao et al. /A synergistic effect of nitrosodimethyl-amine on sterigmatocystin carcinogenesis in rats./ 1978;
Arai et al. /Long-term experiment of maximal non-carcinogenic dose of dimethyl-nitrosamine for carcinogenesis in rats./ 1979;
Ito et al./Induction of preneoplastic and neoplastic lesions in rats treated with Nnitroso compounds./ 1982;
Lijinsky and reuber /Carcinogenesis in rats by nitrosodimethylamine and other nitrosomethylalkylamines at low doses/ 1984. c) Brantom /Dose–response relationships in nitrosamine carcinogenesis. Ph.D. thesis, University of Surrey, Guildford, U.K./ 1983;
Peto et al. / Effects on 4080 rats of chronic ingestion of N-nitrosodiethylamine or Nnitrosodimethylamine: a detailed dose-response study. / 1991a;
Peto et al. / Dose and time relationships for tumor induction in the liver and esophagus of 4080 inbred rats by chronic ingestion of N-nitrosodiethylamine or Nnitrosodimethylamine. / 1991b. d) Cliet et al./ Lack of predictivity of bone marrow micro-nucleus test versus testis micronucleus test: compariso+M21n with four carcinogens. / 1993. e) Inui et al. /Transplacental action of sodium nitrite on embryonic cells of Syrian golden hamster./ 1979, Bolognesi et al. /A new method to reveal the genotoxic effects of N-nitroso-dimethylamine in pregnant mice./ 1988. f) Cesarone et al. /DNA repair synthesis in mice spermatids after treatment with N-methyl-N-nitroso-urea and N,N-dimethylnitrosamine: preliminary results/ 1979. g) Anderson et al. / Effects of imipramine, nitrite, and dimethylnitro-samine on reproduction in mice./ 1978. h) Anderson et al. /Effects of imipramine, nitrite, and dimethylnitrosamine on reproduction in mice./ 1978;
Anderson et al./Transplacental initiation of liver, lung, neuro-genic, and connective tissue tumors by N-nitroso compounds in mice/ 1989;
ATSDR /Toxicological profile for N-nitrosodimethylamine/ 1989;
Alexandrov 1974;
Napalkov and Alexandrov /On the effects of blastomogenic substances during embryogenesis/ 1968;
hattacharyya/ Fetal and neonatal responses to hepatotoxic agents/ 1965. i) Nishie /Comparison of the effects of Nnitrosodimethylamine on pregnant and nonpregnant Holtzman rats./ 1983. j) Haggerty and Holsapple /Role of metabolism in dimethylnitrosamineinduced immunosuppression: a review/ 1990. k) Desjardins et al./Immunosuppression by chronic exposure to N-nitrosodimethylamine (NDMA) in mice./ 1992

These are the corresponding references for the endocrine-related effects data at the time of the assessment (Human Health Endocrine-Related Endpoint(s) Observed) for human health or environment. Text is as stated in the report (i.e., text is verbatim)

Substance declared Human Health s.64c because Endocrine-Related Effects as ONE of MANY Lines of Evidence

No—endocrine-related effects data (as described in Human Health Endocrine-Related Endpoint(s) Observed) was not used as one of the many lines of evidence to determine whether the substance was harmful to the environment or human health at the time of the assessment.

Key Risk Management as of October 2, 2012

● Prohibition of Certain Toxic Substances Regulations, 2005

The term “Key” describes the proposed or final risk management measures to address the principal sources of overall exposure for those substances identified as meeting one or more of the criteria under section 64 of CEPA 1999 (see Assessment Conclusion under Canadian Environmental Protection Act, 1999, Section 64)


Guidance on How To Read Table 3.1

NOTE 1: Table 3.1 is not to be considered as a definitive nor a complete list of existing substances with endocrine-related effects. There are many substances assessed during the period of 1994 to 2000 with known or potential endocrine-related effects that are not included in this list as they were outside the scope of this query.

NOTE 2: Assessments can be found at:

Chemical Abstract Service Registry Number (CAS RN): The Chemical Abstracts Service is the property of the American Chemical Society. As described by the American Chemical Society, the CAS RN is universally used to provide a unique, unmistakable identifier for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides an unambiguous way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names.

Priority Substances List (PSL): The Canadian Environmental Protection Act (CEPA) required the Ministers of the Environment and of Health to establish a Priority Substances List (PSL), that identifies substances to be assessed on a priority basis to determine whether they pose a significant risk to the health of Canadians or to the environment. Assessments of substances placed on the PSL are the shared responsibility of Environment Canada and Health Canada. Assessments of the first 44 substances placed on the PSL (referred to as PSL1) were completed by February 1994. Following the recommendations of a multi-stakeholder Expert Advisory Panel, 25 additional substances were added to the PSL (referred to as PSL2).

Report Publication Type: This column indicates the types of publications used to disseminate assessment results from the Government of Canada. Types of publications include: screening assessment reports; state of science reports; priority substances list assessment reports and follow-up reports.

Assessment Conclusion under Canadian Environmental Protection Act, 1999, Section 64: This column identifies the assessment conclusion under CEPA 1999 as meeting or not meeting one or more of the criteria under section 64:

“A substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that:

  • (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
  • (b) constitute or may constitute a danger to the environment on which life depends; or
  • (c) constitute or may constitute a danger in Canada to human life or health.”

Please note that State of Science reports never conclude under section 64, CEPA 1999.