Registration Dossier
Registration Dossier
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EC number: 218-638-5 | CAS number: 2210-25-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
It is concluded that, when tested at dose levels up to 5000 ul/plate in water, N-isopropylacrylamide was not mutagenic in this bacterial test system.
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with N-isopropylacrylamide at any dose level, either in the presence or absence of S-9 mix.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 January 1990 - 26 January 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: GLP, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, 1989
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. FDA, Title 21 Code of Federal Regulations Part 58, Federal Register, 22 December 1978 and subsequent Amendments
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Protection Agenct, (FIFRA) Title 40 Code of Federal Regulations Part 160, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Protection Agency, (TSCA) Title 40 Code of Federal Regulations Part 792, Federal Register, 29 November 1983 and subsequent amendment Federal Register 17 August 1989
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of Health and Welfare Notification No. Yakuhatsu 313 Pharmaceutical Affairs Bureau, 31 March 1982 and subsequent amendment Notification No. Yakuhatsu 870, Pharmaceutical Affairs Bureau, 5 October 1988
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of Agriculture, Forestry and Fisheries, 59 NohSan, Notification No. 3850, Agricultural Production Bureau, 10 August 1984
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of International Trade and Industry, Directive 31 March 1984
- Qualifier:
- according to guideline
- Guideline:
- other: OECD ISBN 92-64-12367-9, Paris 1982
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: HRC 3.1.90/3.
- Expiration date of the lot/batch: April 1990
- Purity: 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 °C in the dark
- Solubility and stability of the test substance in the solvent/vehicle: not determined in this study - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- his G46 rfa uvrB, his C3076 rfa uvrB, his D3052 rfa uvrB pKM 101, his G46 rfa uvrB pKM 101, respectively
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- his D3052 rfa uvrB
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- derivered from strain E. coli B/r
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Dose range finding test: 5000, 500, 50, 5 ug/plate
Mutation test: 5000, 2500, 1250, 625, 312.5 ug/plate
NIPAM was not toxic towards the tester strains. Therefore 5000 ug/plate was chosen as the top dose level in the mutation test - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- not specified
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- It is concluded that, when tested at dose levels up to 5000 ul/plate in water, N-isopropylacrylamide was not mutagenic in this bacterial test system.
No substantial increases in revertant colony numbers of any of the tester strainswere observed following treatment with N-isopropylacrylamide at any dose level, either in the presence or absence of S-9 mix. - Executive summary:
It is concluded that, when tested at dose levels up to 5000 ul/plate in water, N-isopropylacrylamide was not mutagenic in this bacterial test system.
No substantial increases in revertant colony numbers of any of the tester strainswere observed following treatment with N-isopropylacrylamide at any dose level, either in the presence or absence of S-9 mix.
Reference
The current positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The substance is not classified for Genetic toxicity as the Ames study on the test substance NIPAM was negative.
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