Hydantoin

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:

not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Mutagenicity testing of imidazole and related compounds

Author:

Forster, R. et al.

Year:

1992

Bibliographic source:

Mutation Research, 298 (1992) 71-79

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not applicable

Principles of method if other than guideline:

The Ames test was performed essentially as described by Ames et al. (1975) and Maron and Ames (1983). At least two independent experiments, with three replicate plates at each test point were performed.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydantoin

EC Number:

207-313-3

EC Name:

Hydantoin

Cas Number:

461-72-3

Molecular formula:

C3H4N2O2

IUPAC Name:

hydantoin

Test material form:

not specified

Specific details on test material used for the study:

Test material was obtained from Sigma.

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 102

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0, 0.1, 0.33, 1.0, 3.3, 10.00 mg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

untreated

Negative solvent / vehicle controls:

yes

Remarks:

DMSO, 100 µl

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

5 µg; TA 98 (without S9)

Controls 2

Positive control substance:

sodium azide

Remarks:

5 µg; TA 100 (without S9)

Controls 3

Positive control substance:

mitomycin C

Remarks:

0.5 µg; TA 102 (without S9)

Controls 4

Positive control substance:

other: nitro-ortho-phenylenediamine (NOPD)

Remarks:

50 µg; TA 97 (without S9)

Controls 5

Positive control substance:

other: 2-aminoanthracene

Remarks:

4 µg; all strains (with S9)

Details on test system and experimental conditions:

Rat liver S9 homogenate (prepared from the livers of young male rats after pre-treatment with beta-naphthoflavone and phenobarbital). Solutions of hydantoin was prepared freshly before use in dimethyl sulphoxide.

Rationale for test conditions:

Not specified

Evaluation criteria:

Not specified

Statistics:

Not specified

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The test materials was tested up to 10 mg/plate without appreciable toxicity. No evidence of mutagenic activity was observed in any of the experiments performed, in the absence or presence of rat liver S9 metabolic activation, using Salmonella typhimurium tester strains TA98, TA100, TA97 and TA102.

Applicant's summary and conclusion

Conclusions:

The mutagenic potential of Hydantoin was tested in the Ames test. No evidence of mutagenic activity was observed in any of the experiments performed, in the absence or presence of rat liver S9 metabolic activation, using Salmonella typhimurium tester strains TA98, TA100, TA97 and TA102. Therefore Hydantoin was considered non-mutagenic under the conditions of the test.