N-(hydroxymethyl)acrylamide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented report of a guideline study conducted to GLP.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As reported by Ames et al. (1975) with modifications described in Zeiger et al. (1988) and Haworth et al. (1983).

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-(hydroxymethyl)acrylamide

EC Number:

213-103-2

EC Name:

N-(hydroxymethyl)acrylamide

Cas Number:

924-42-5

Molecular formula:

C4H7NO2

IUPAC Name:

N-(hydroxymethyl)acrylamide

Details on test material:

- Name of test material (as cited in study report): N-Methylolacrylamide
- Substance type: Non-volatile, organic
- Physical state: Solid
- Analytical purity: approximately >98%
- Impurities (identity and concentrations): unkown but evidence indicates that 1% may have been a polymer of Nmethylolacrylamide,
which would not have been detected by the analytical methods used
- Composition of test material, percentage of components: 100%
- Isomers composition: not applicable
- Purity test date: no data
- Lot/batch No.: 1-45-000
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: storage at 5°C

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

other: S. typhimurium strains TA 97, TA 98, TA 100, TA 1535

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254- induced S9 from male Sprague Dawley rat or Syrian hamster liver

Test concentrations with justification for top dose:

0, 100, 333, 1,000, 3,333, 10,000 µg/plate

Vehicle / solvent:

Buffer or S-9 mix

Results and discussion

Test results

Species / strain:

other: S. typhimurium strains TA 97, TA 98, TA 100, and TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Toxicity was observed at 10,000 mg/plate and since the test article is infinitely soluble this must have been due to cytotoxicity and not to precipitation.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: S. typhimurium strains TA 97, TA 98, TA 100, TA 1535

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

N-methylolacrylamdie did not increase the number of histidine reverants in Salmonella typhimurium at concentrations as high as 10,000 mg/plate.