5,5-Dimethylimidazolidine-2,4-dione, reaction products with oxirane

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 March 2007 to 23 April 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione

EC Number:

701-388-0

Cas Number:

26850-24-8

IUPAC Name:

1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione

Test material form:

other: pale yellow solid block

Details on test material:

- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction was derived from rats induced with phenobarbitone/beta-napthoflavone mixture.

Test concentrations with justification for top dose:

50, 150, 500, 1500 and 5000 ug/plate

Vehicle / solvent:

Water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

other: 2-aminoanthracene

Evaluation criteria:

Dose-related increase in revertant frequency over the dose range tested and/or reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. A test material will be considered non-mutagenic (negative) if the above criteria aare not met.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: not-mutagenic

Applicant's summary and conclusion

Conclusions:

The substance was considered to be non-mutagenic under the conditions of this test.

Executive summary:

The substance underwent a test to evaluate the mutagenic potential in the Ames test according to the OECD Guideline 471 employing Salmonella typhimurium strains TA1535, TA1537, TA100, TA98, and Eschericia coli WP2, with and without S9 (metabolic activation). Under the conditions of these tests the substance is considered to be non-mutagenic.