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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:
other information
Study period:
Jan to Feb 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP study, comparable to Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no bacteria strain included to detect cross-linking mutagens (e.g. TA 102)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 74.804
- Batch No.: BA 76700

Method

Target gene:
Histidine gene locus
Species / strain
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Metabolic activation system:
liver S9-mix from Aroclor 1254 -treated rats
Test concentrations with justification for top dose:
AD-Cyanhydrin: six concentrations from25 to 1000 µg/plate
9-Acridinamine: 100.0 µg/plate
2-Aminoanthracene: 2.0 µg/plate
2-Nitrofluorene: 10.0 µg/plate
Benzo[a]pyrene: 5.0 µg/plate
Sodium azide: 2.0 µg/plate
Cyclophosphamide: 400 µg/plate



Controls
Solvent controls:
yes
Remarks:
DMSO or phosphate buffer pH 7.4, 0.1 mol/l
Positive controls:
yes
Positive control substance:
other: 9-Acridinamine, 2-Aminoanthracene, 2-Nitrofluorene, Benzo[a]pyrene, Sodium azide, Cyclophosphamide

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
growth inhibition were observed on TA 1535, TA 1537 and TA 1538 starting at 500 µg/plate and on TA 98 at 1000 µg/plate without S9-mix
Vehicle controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Precipitates in the agar were found at least in the highest concentration.

Applicant's summary and conclusion

Executive summary:

AD-Cyanhydrin was examined for mutagenic activity up to 1000 µg/plate in the five histidine-dependent Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98 with and without metabolic activation. Growth inhibition could be observed on TA 1535, TA 1537 and TA 1538 starting at 500 µg/plate and on TA 98 at 1000 µg/plate without S9-mix. Precipitates in the agar were found at least in the highest concentration

There was no evidence for a mutagenic activity of AD-Cyanhydrin, when tested up to the dose level of 1000 µg/plate in the absence and presence of S9 mix.