Registration Dossier
Registration Dossier
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EC number: 941-718-2 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to sound scientific principles.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to sound scientific principles.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without metabolic activation 0.6 ug/mL; with metabolic activation 5000 ug/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
Exposure to test material in the presence of and in the absence of metabolic activation did not increase the induction of mutations. Therefore isododecane is not considered to be mutagenic in this test system. - Executive summary:
This data is being read across from the source study that tested Isododecane based on analogue read across.
Exposure to test material in the presence of and in the absence of metabolic activation did not increase the induction of mutations. Therefore isododecane is not considered to be mutagenic in this test system.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 2,2,4,6,6-pentamethylheptane
- EC Number:
- 236-757-0
- EC Name:
- 2,2,4,6,6-pentamethylheptane
- Cas Number:
- 13475-82-6
- Molecular formula:
- C12H26
- IUPAC Name:
- 2,2,4,6,6-pentamethylheptane
Constituent 1
Method
- Target gene:
- Chinese Hamster V79 cells in vitro (V79/HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Chinese Hamster V79 cells in vitro (V79/HPRT)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor
- Test concentrations with justification for top dose:
- without S9: 0.1, 0.3, 0.6, 1, 2, 3 ug/mL
with S9: 100, 500, 1000, 5000 ug/mL - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- Remarks:
- DMSO
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- without metabolic activation 0.6 ug/mL; with metabolic activation 5000 ug/mL
- Vehicle controls validity:
- valid
- 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: negative with and without metabolic activation
Exposure to test material in the presence of and in the absence of metabolic activation did not increase the induction of mutations. Therefore isododecane is not considered to be mutagenic in this test system. - Executive summary:
Exposure to test material in the presence of and in the absence of metabolic activation did not increase the induction of mutations. Therefore isododecane is not considered to be mutagenic in this test system.
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