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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance number: 89/163
- Batch number: FIS 4/146/3
- Analytical purity: 99.4%

Method

Target gene:
his
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 mix
Test concentrations with justification for top dose:
0, 20, 100, 500, 2500 and 5000 µg/plate (standard plate and preincubation test)
Vehicle / solvent:
- Vehicle used: water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with metabolic activation: 2-aminoanthracene, without metabolic activation: N-methyl-N' -nitro-N-nitrosoguanidine, 4-nitro-o-phenyleridiamine, 9-aminoacridine
Details on test system and experimental conditions:
METHOD OF APPLICATION: standard plate test (SPT) and preincubation test (PIT)
SPT: incubation at 37°C for 48 hours
PIT: preincubation at 37°C for the duration of 20 minutes; incubation at 37°C for 48 hours

NUMBER OF REPLICATIONS: three plates per dose/control
Evaluation criteria:
In general, a substance to be characterised as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control);
- dose-response relationship;
- reproducibility of the results.

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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY: No bacteriotoxic effect (reduced his- background growth) was observed.
SOLUBILITY: Complete solubility of test substance in aqua dest.
Remarks on result:
other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:
Not-mutagenic in the Ames test (OECD471) using S. typh. TA98, TA100, TA1535 and TA1537 +/- metabolic activation.