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Toxicological information

Genetic toxicity: in vitro

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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:
1996
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

Constituent 1
Chemical structure
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

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.