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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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Cross-reference
Reason / purpose:
reference to same study

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
Details on test material:
- Name of test material (as cited in study report): Genamin CC 100 D

Method

Target gene:
Histidine (S. typhimurium)
Tryptophan (E. coli)
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
4, 20, 100, 500, 2500, 10000 µg/plate (first experiment)
0.16, 0.8, 4, 20, 100, 500 µg/plate (second experiment)
Vehicle / solvent:
- Vehicle/solvent used: acetone
Controls
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: - S9: Sodium azide (TA 100, TA 1535), 9-Aminoacridine (TA 1537), 2-Nitrofluorene (TA98, TA 1538), N-Methyl-N-nitro-N-nitrosoguanidine (WP2 uvrA); +S9: Benzo(a)pyrene, 2-Aminoanthracene (all strains)

Results and discussion

Test results
Species / strain:
other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The test item was tested for its mutagenic potential in 5 Salmonella typhimurium strains (TA 98, TA 100, TA 1535, TA 1537, TA 1538) and 1 Escherichia coli strain (WP2 uvr A). The test substance proved to be very toxic to the strains at 20 µg/plate and to form precipitations at 500 µg/plate, the highest concentration tested in the second experiment.

Either with or without metabolic activation, the substance was not mutagenic in the present test system.

Applicant's summary and conclusion

Conclusions:
Based on the study results it is concluded that the test material is not mutagenic in the bacterial test systems investigated either in the absence or in the presence of an exogenous metabolizing system (S-9).
Executive summary:

An investigation on induction of gene mutations in bacteria (OECD 471) was performed with coco alkylamines ("Genamin CC 100 D"). The test compound (purity approx. 100%) was solved in acetone and tested in doses of 0.16µg/plate up to 10 mg/plate with and without liver S-9 mix from Arochlor induced male Sprague Dawley rats. Only doses up to 100 µg/plate could be evaluated due to strain specific strong cytotoxic effects at doses of 20 or 100 µg/plate and higher doses. In TA1537 the bacterial background lawn was reduced already at 4µg/plate in the second experiment. Precipitaions were seen at 500 µg/plate and higher doses. No increases in the number of revertants were induced in any of the tester strains, e.g. Salmonella typhimurium TA100, TA1535, TA1537, TA1538, TA98 and E. coli WP2uvrA. Summarizing it can be stated that the test article genamin CC 100 D is not mutagenic in these bacterial test systems either with or without exogenous metabolic activation at the dose levels investigated.