Registration Dossier
Registration Dossier
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EC number: 905-459-9 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Study performed according to Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Guideline No. 473
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
- EC Number:
- 905-459-9
- Molecular formula:
- C12H18
- IUPAC Name:
- Reaction mass of 1,3-diisopropylbenzene and 1,4-diisopropylbenzene
- Details on test material:
- Lot/batch No.: CAF5267
Purity: 99.8 %
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung cells (CHL/IU)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from rat liver (induction with phenobarbital and 5,6-benzoflavone)
- Test concentrations with justification for top dose:
- -S9 mix (continuous treatment): 0, 0.0038, 0.0075 and 0.015 mg/mL
-S9 mix (short-term treatment): 0, 0.0019, 0.0038 and 0.0075 mg/mL
+S9 mix (short-term treatment): 0, 0.03, 0.06 and 0.12 mg/mL - Vehicle / solvent:
- Acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- Positive controls:
- yes
- Remarks:
- see below
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- Positive controls:
-S9 mix: Mitomycin C
+S9 mix: Cyclophosphamide
Continuous treatment: 24 and 48 hrs
Short-term treatment: 6 hrs
2 plates/test - Evaluation criteria:
- according to OECD Guideline No. 473
- Statistics:
- Yes
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster lung cells (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See Additional information on results
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Cytotoxicity:
Short-term treatment: >= 0.015 mg/mL
Continuous treatment: >= 0.03 mg/mL
Applicant's summary and conclusion
- Conclusions:
- The TS caused no chromosomal aberrations or polyploidy in Chinese hamster lung cells (CHL/IU), with or without an exogenous metabolic activation system.
- Executive summary:
The TS was tested in an in vitro mammalian chromosome aberration test with Chinese hamster lung cells (CHL/IU) according to OECD Guideline No. 473.
The test concentrations were as follows:
-S9 mix (continuous treatment; 24 or 48 hrs): 0, 0.0038, 0.0075 and 0.015 mg/mL
-S9 mix (short-term treatment; 6 hrs): 0, 0.0019, 0.0038 and 0.0075 mg/mL
+S9 mix (short-term treatment; 6 hrs): 0, 0.03, 0.06 and 0.12 mg/mL.
The TS caused no chromosomal aberrations or polyploidy in Chinese hamster lung cells (CHL/IU), with or without an exogenous metabolic activation system.
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