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Toxicological information

Genetic toxicity: in vitro

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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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,4,4-trimethyl pentene (also known as diisobutylene and diisobutene).
- Physical state: clear, colourless liquid.
- Analytical purity: Batch R11 95.19%, Batch 155833 no information
- Lot/batch No.: Batch No 2 (a 50:50 mixture of two original batches of 2,4,4-trimethyl pentene - the details of which are as follows: Batch No. R11 supplied by Shell and Batch No. 155833 supplied by Erdolchemie.
- Expiration date of the lot/batch: 29 April 1997
- Storage condition of test material: Under nitrogen, protected from light in a cool store

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Arochlor-induced rat liver S9
Test concentrations with justification for top dose:
Range finding test: 5, 15, 50, 150, 500, 1500 µg 2,4,4 trimethyl pentene
Main test with pre-incubation: 50, 150, 500 and 1500 µg 2,4,4 trimethyl pentene
Vehicle / solvent:
Vehicle(s)/solvent(s) used: ethanol
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
ethanol
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
as a solution in DMSO for TA1535 +S9 and WP2uvrA +S9
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
as a solution in DMSO for TA1537 -S9
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
as a solution in DMSO for TA98 +S9
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
as a solution in DMSO for TA1537 +S9, TA100 +S9 and TA98 +S9
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
as a solution in DMSO for TA1535 +S9, TA100 +S9, WP2uvrA +S9
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins at 37°C
- Exposure duration: 2 days at 37°C

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated. For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article.
Statistics:
The mean and standard deviation of the number of revertants per plate were calculated. No statistical analyses.

Results and discussion

Test resultsopen allclose all
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:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

2,4,4-trimethyl pentene did not exhibit any mutagenic activity under the conditions of test.
Executive summary:

The mutagenic potential of 2,4,4 -trimethylpentene was assessed in a bacterial reverse mutation assay (the Ames test) with and witout metabolic activation. 2,4,4-trimethyl pentene, did not exhibit any mutagenic activity under the conditions of test.