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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
other: weak mutagenicity
Cytotoxicity:
yes
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
other: weak mutagenicity
Cytotoxicity:
yes

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
ambiguous

Weakly mutagenic at toxic levels
Executive summary:

Toxicity to the bacteria, observed as thinning of the background lawn of microcolonies was observed in each of three assays. Toxicity occured with all strains at various dose levels in both the presence and absence of S9 mix. Toxicity was also observed as a reduction in the number of revertant colonies. A reduction in the number of revertant colonies was observed in the first mutation assay and the retest with TA 1535 with and without S9 mix and in the second mutation assay, in the presence od S9 mix only. A reduction in colony numbers was also observed with TA 98 in all three assays in the presence of S9 mix only.

Using WoE approach, it was concluded that cyanogen was weakly mutagenic to Salmonella typhimurium TA 100 and E. coli WP2uvrA (pKM101) in the presence and absence of S9 mix. No mutagenic activity was observed with TA 1535, TA 1537 or TA 98.