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

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No confirmation in an independent experiment

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

5,5-dimethylhydantoin

EC Number:

201-051-3

EC Name:

5,5-dimethylhydantoin

Cas Number:

77-71-4

Molecular formula:

C5H8N2O2

IUPAC Name:

5,5-dimethylimidazolidine-2,4-dione

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: S.typhimurium TA1535, TA 1537, TA98, TA100, TA1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix from male Sprague-Dawley rats

Test concentrations with justification for top dose:

100, 500, 2500, 5000 and 10000 μg/plate

Vehicle / solvent:

Water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2- Aminoanthracene (CAS 90-45-9), 2-Nitrofluorene, (CAS 607-57-8) 1,3 Propane Sultone, (CAS 1120-71-4), 9-Aminoacridine (CAS 90-45-9)

Details on test system and experimental conditions:

The experimental materials, methods and procedures are based on those described by Ames, B.N., et al (1975) Mutation Research 31: 347-364 and Yahagi et al (1977) Mutation Research 48- 121-130
The Salmonella/Mammalian-Microsome Assay was divided into two phases. The first phase, a preliminary toxicity determination was used to establish the dose range over which the test article will be assayed. The maximum dose established was 10000 μg/plate. The second phase was the pre incubation mutagenicity assay of the test article.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: S.typhimurium TA1535, TA 1537, TA98, TA100, TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

No toxicity was observed up to 10000μg /plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

DMH is not mutagenic in this assay