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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pre-GLP

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Executive summary on the ETAD project T 2015 toxicological testing of major colorants, with attachments and cover letter dated June 3, 1988
Author:
ETAD
Year:
1988
Bibliographic source:
NTIS/OTS 0000621
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
no details provided; ETAD toxicological method # 005 (July 1980)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 mix
Test concentrations with justification for top dose:
0 - 0.8-4-20-100-500 - 2500 µg/Platte, 6 concentrations
Vehicle / solvent:
acetone

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation

The test material caused gen mutations in S.typhimurium.