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Toxicological information

Genetic toxicity: in vitro

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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:
1988-03-15 to 1988-03-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (e.g. used dose level too low according to current requirements)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Sodium ethylenesulphonate (Sodium vinylsulphonate)

Method

Species / strain
Species / strain / cell type:
other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and E.coli WP2uvrA
Metabolic activation:
with and without
Metabolic activation system:
microsomal enzyme system (S-9 mix) from Aroclor 1254 induced Sprague-Dawley rat liver
Test concentrations with justification for top dose:
Toxicity test (first and second experiment) and mutagenicity test (first experiment): 0, 4, 20, 100, 500, 2500, 10000 µg/plate of the 30 % Sodium ethylenesulphonate solution.
Mutagenicity test: 5000 µg/plate of the 30 % Sodium ethylenesulphonate solution was chosen as the highest dose in the second experiment
Vehicle / solvent:
aqua bidest
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: - S9-mix: Na-azide (TA 100, TA 1535), 9-Aminoacridine (TA 1537), 2-Nitrofluorene (TA98, TA1538), N-Methyl-N-nitro-N-nitrosoguanidine (WP2uvraA) + S-9-mix: Benzo[a]pyrene,2-Aminoanthracene (TA 98, TA 100, TA 1535, TA 1537, TA 1538, WPuvrA)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION

- Exposure duration: 48 to 72 hours

SELECTION AGENT (mutation assays): Histidine and biotine rich agar. With E.coli histidine is replaced by tryptophan.

NUMBER OF REPLICATIONS: Two independent experiments were performed, each in triplicate.

NUMBER OF CELLS EVALUATED: no data

DETERMINATION OF CYTOTOXICITY
- Method: surviving fraction

OTHER EXAMINATIONS:
- Determination of polyploidy: no data
- Determination of endoreplication: no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and E.coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The test solution, containing 30% Sodium ethylenesulphonate, did not demonstrate mutagenic potential. Under the conditions of the present bacterial reverse mutation assay the maximum test concentration of Sodium ethylenesulphonate was 3000 µg/plate.