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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reported by the U.S. National Toxicology Program, performed according to good laboratory practices. Tests performed by two independent laboratories, each in triplicate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Principles of method if other than guideline:
See Zeiger et al. 1985. Environ Mutagen. 7:213-232.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
See rat and mouse 13 week studies

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 S9
Test concentrations with justification for top dose:
0, 33.3, 100, 333.3, 1000, 3333.3, 6666.7 ug/plate
Controls
Untreated negative controls:
yes
Positive controls:
yes
Details on test system and experimental conditions:
See Zeiger et al. (1985) Environ. Mutagen 7:213-232.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
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):
negative

Tetrachlorophthalic anhydride was negative in the Ames test without and without metabolic activation.
Executive summary:

Tetrachlorophthalic anhydride was negative in the Ames test without and without metabolic activation.