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Registration Dossier
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EC number: 700-989-5 | CAS number: -
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is rated a "1" because it applied GLP and used appropriate testing procedures.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Phthalate Ester Testing in the National Toxicology Program's Environmental Mutagenesis Test Development Program
- Author:
- Zeiger E, et al
- Year:
- 1 982
- Bibliographic source:
- Environ Health Perspect 45:99-101
- Reference Type:
- publication
- Title:
- Mutagenicity Testing of di(2-ethylhexyl) Phthalate and Related Chemicals in Salmonella
- Author:
- Zeiger E, et al
- Year:
- 1 985
- Bibliographic source:
- Environ Mutagen 7(2):213-232
Materials and methods
- Principles of method if other than guideline:
- Method: other: Ames BN et al. Mutat Res. 31:347-364.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Di-''isodecyl'' phthalate
- EC Number:
- 247-977-1
- EC Name:
- Di-''isodecyl'' phthalate
- Cas Number:
- 26761-40-0
- Molecular formula:
- C28H46O4
- IUPAC Name:
- 1,2-benzenedicarboxylic acid, di-isodecyl ester
- Details on test material:
- IUCLID4 Test substance: other TS: DIDP with different CAS#
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:
- homogenates of Aroclor 1254-induced Sprague-Dawley rat and Syrian hamster liver S9
- Test concentrations with justification for top dose:
- from 100 up to 10,000 ug/plate
- Vehicle / solvent:
- 95% ethanol
- Details on test system and experimental conditions:
- IUCLID4 Type: Ames test
- Evaluation criteria:
- A positive mutagenic response was defined as a reproducible, dose-related increase in his+ revertants over spontaneous level
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:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: other: Salmonella strains TA98, TA100, TA1535, TA1537
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic in the preincubation modification of the Salmonella microsome test.
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