Registration Dossier
Registration Dossier
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EC number: 211-185-4 | CAS number: 632-79-1
Genetic toxicity: in vitro
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:
- 1 993
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 substance name:
- Tetrachlorophthalic anhydride
- EC Number:
- 204-171-4
- EC Name:
- Tetrachlorophthalic anhydride
- Cas Number:
- 117-08-8
- IUPAC Name:
- 4,5,6,7-tetrachloro-2-benzofuran-1,3-dione
- Details on test material:
- See rat and mouse 13 week studies
Constituent 1
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.
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