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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: valid scientific study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1983
Reference Type:
publication
Title:
No information
Author:
O'Neill et al.
Year:
1977
Bibliographic source:
Mutation Research 45 91-101
Reference Type:
publication
Title:
No information
Author:
Snee and Irr.
Year:
1981
Bibliographic source:
Mutation Research 85 77-93

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: similar to OECD 476
Principles of method if other than guideline:
Method: other; similar to OECD 476
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

TS-Freetext:
98.5% Acetone cyanohydrin. Certificate of analysis.

Method

Target gene:
HPRT
Species / strain
Species / strain / cell type:
other: Chinese hamster cells CHO-K1-BH4
Metabolic activation:
with and without
Metabolic activation system:
Arocor-induced rat liver S9
Test concentrations with justification for top dose:
100 - 950 microgrammes/ml

Results and discussion

Test results
Key result
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 500 microgram/ml and higher
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Chinese hamster cells CHO-K1-BH4

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative