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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
genetic toxicity in vitro, other
Remarks:
preincubation method according to Ames, Mutat. Res. 31,347(1975); Maron, Mutat. Res.113,173(1983)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
Mutagenicity Test Data of Existing Chemical Substances
Author:
JETOC (Jap. Chem. Ind. Ecolog. Toxicol. Inform. Center)
Year:
2000
Bibliographic source:
JETOC (Jap. Chem. Ind. Ecolog. Toxicol. Inform. Center)Suppl. 2, 33-39, 71, 170-171.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: according to Ames, Mutat. Res. 31,347(1975); Maron, Mutat. Res.113,173(1983)
Principles of method if other than guideline:
Preparation of S9 Fraction:
Male Sprague-Dawley rats were used for the preparation of liver fractions. Sodium phenobarbital and 5,6-benzofravone were used as an inducer of the rat metabolic activation system. Sodium phenobarbital was injected intraperitoneally into the rats 4 days before killing and 1, 2 and 3 days before killing 5,6-benzoflavone was injected intraperitoneally; from these rats liver S9 fraction was prepared according to Ames et al. (1975), Methods for detecting carcinogens and mutagens in the Salmonella /mammalian microsome mutagenicity test, Mutat. Res. 31, 347-364. S9 was dispensed into freezing ampules and stored at -80°C. Once the stock S9 had been thawed, remained S9 was not reused.

Evaluation criteria:
Twohold rule was used for data evaluation. the chemicals are considered to be mutagenic when dose-related increase in revertant colony count is observed and the number of revertant colonies per plate with the test substance is more than twice that of the negative control (solvent control) and when a reproducibility of test result is observed.
GLP compliance:
not specified
Type of assay:
other: Ames test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
purity >99%

Method

Target gene:
Salmonella typhimurium TA98, TA100, TA1535, TA1537, Escherichia coli WP2uvrA/pKM101
Test concentrations with justification for top dose:
(1) 0, 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate in DMSO
(2) 0, 78.1, 156, 313, 625, 1250, 2500, 5000 µg/plate in DMSO
Controls
Untreated negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
not specified

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
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'.

Any other information on results incl. tables

negative

Applicant's summary and conclusion

Conclusions:
Negative
Executive summary:

Test results negative for S. typhimurium, TA 1535, TA 1537, TA 98 and TA 100(all strains/cell types

tested).