Registration Dossier
Registration Dossier
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EC number: 204-812-8 | CAS number: 126-92-1
Genetic toxicity: in vitro
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Similar to Guideline study with acceptable restrictions.
Data source
Reference
- 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:
- Environmental Mutagenesis 7:213-232 (1985)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : no E.coli strain tested
- GLP compliance:
- no
- Remarks:
- Study conducted prior to GLP implementation.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 126-92-1 (purity 39.6%)
- IUPAC Name:
- 126-92-1 (purity 39.6%)
- Details on test material:
- - Name of test material (as cited in study report): Sodium (2-ethylhexyl)-alcohol sulfate
- Physical state: No data
- Analytical purity: 39.6%
- Lot/batch No.: A668K4
- Storage condition of test material: No data
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- -S9: 5, 15, 50, 150, 500, and 1500 µg/plate
+S9: 5, 15, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: sodium azide (TA1535, TA100); 4-nitro-o-phenylenediamine (TA98); 9-aminoacridine (TA1537) / -S9: 2-aminoanthracene
- Statistics:
- No.
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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
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