Registration Dossier
Registration Dossier
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EC number: 273-050-6 | CAS number: 68936-98-1 The complex combination of hydrocarbons produced by the distillation of products from cumene manufacturing process. It consists primarily of diisopropylbenzene with various small amounts of C4 substituted benzenes and heavier non-aromatic hydrocarbons.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline 471 (adopted 1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Laus GmbH)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Cumene bottoms (Benzene, (1-methylethyl)-, distn. Residues)
- IUPAC Name:
- Cumene bottoms (Benzene, (1-methylethyl)-, distn. Residues)
- Details on test material:
- Batch number 341309
Yeliowish Liquid.
UVCB substance (Benzene, (1-methylethyl)-, distn. Residues)
CAS No 68936-98-1
This substance is an UVCB. Under this definition, no components can be considered as impurities (purity 100%)
Constituent 1
Method
- Target gene:
- His-
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500, 5000 µg/plate in the 1st experiment
0, 314, 628, 1256, 2512, 5024 µg/plate in the 2nd experiment - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine; Sodium azide; 2-Amino-anthracene
- Details on test system and experimental conditions:
- experiment 1: plate incorporation method
experiment 2: pre-incubation method
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Negative results in experiment 1 and 2.
- 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
The test item is considered as not mutagenic under the conditions of the test.
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