Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature (handbook)

Data source

Reference
Reference Type:
review article or handbook
Title:
Patty's Industrial Hygiene and Toxicology
Author:
Rowe and McCollister
Year:
1982
Bibliographic source:
Clayton and Clayton (eds), Vol.2C, 3rd ed. (1982), John Wiley & Sons, New York, 4604 - 4605, 4608, 4701

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: other: Ames test, no further information provided
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-2-ol
EC Number:
200-908-9
EC Name:
2-methylbutan-2-ol
Cas Number:
75-85-4
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-2-ol

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Test concentrations with justification for top dose:
no data

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
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 genetic toxicity of the test item was determined in an Ames test. No genetic toxicity was observed in this test.
Executive summary:

The genetic toxicity of the test item was determined in an Ames test. Salmonella typhimurium strains (TA 1535, TA 1537 and TA1538) were used with and without metabolic activation. No genotoxicity effects were observed during this study.