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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:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
mutant histidine gene
Species / strainopen allclose all
Species / strain / cell type:
other: S. typhimurium TA 1535, TA 100, TA 1537, TA 98
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix was made from the livers of male Sprague Dawley rats, which received a single intraperitoneal injection of 500 mg/kg bw Aroclor 1254, dissolved in corn oil, 5 days prior to sacrifice.
Test concentrations with justification for top dose:
standard plate test (SPT):
0, 20, 100, 500, 2500, 5000 µg/plate with and without S9 mix
preincubation assay:
0, 20, 100, 500, 2500, 5000 µg/tube with and without S9 mix
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: deionized water (test item); DMSO (other positive controls)
- Justification for choice of solvent/vehicle: Due to the good solubility of the test substance in water
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Remarks:
4-nitro-1,2-phenylene diamine (TA 98), N-Methyl-N´-nitro-N-nitrososguanidine (only TA 1535, TA 100), 9-aminoacridine (TA 1535), 2-aminoanthracene (TA 1535, TA 100, TA 1537, TA 98, E. coli with S9 mix), 4-nitroquinoline-N-oxide (E. coli)
Evaluation criteria:
The lest chemical is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies. i.e.about doubling of the spontaneous mutation rate in at least one tester strain either without 5·9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in thls test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions int!wo experiments carried out independently of each other.
Statistics:
no statistics perfomed; evaluation based on criteria mentioned above

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 100, TA 1537, TA 98, and E. Coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
A very slight decrease in the number of revertants was occassionally observed depending on the strain and test conditions at doses >= 2500 µg/plate.
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
- Precipitation: No precipitation was found
An increase in number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of S-9 mix.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

The test substancewas evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and E. coli WP2 uvrA, performed according to OECD TG 471. The test material was considered to be non-mutagenic without and with S9 mix in the standard plate test as well as in the preincubation test.