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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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report was not available although data have been peer-reviewed in reference work (EHC 218, 2000).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1992
Report Date:
1992
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Test concentrations with justification for top dose:
50, 100, 150, 225 and 300 micrograms per ml with 5% S9; 5, 50, 75, 100 and 130 micrograms per ml in the absence of S9
Details on test system and experimental conditions:
HGPRT assay

Results and discussion

Test results
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Observed at the highest dose level with a dose-related trend both in presence and absence of S9
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: CHO

Applicant's summary and conclusion

Conclusions:
TBEP was not genotoxic under the conditions of this test system either with or without metabolic activation.
Executive summary:

To evaluate the potential of TBEP for mutagenicity in mammalian cells, the substance was tested in the Chinese Hamster Ovary HGPRT mammalian cell forward gene mutation assay with and without metabolic activation. Test concentrations were 50, 100, 150, 225 and 300 micrograms per ml with 5% S9; 5, 50, 75, 100 and 130 micrograms per ml in the absence of S9. Cytotoxicity was observed at the highest dose level with a dose-related trend both in presence and absence of S9. There was no evidence of mutagenicity at any dose tested, with or without metabolic activation.

The study report was not available, however the data have been peer-reviewed in two reference works (IPCS EHC 218, 2000 and ECETOC JACC report 21, 1992). The data reported in these publications is considered adequate to satisfy the requirements for this endpoint.