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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
comparable to guideline study GLP, Comparable to OECD 476 and OPPTS 870.5300 Reliability 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
yes
Remarks:
yes Information on number of cells used and other important parts of the experimental design are not provided.
Principles of method if other than guideline:
Similar to OECD 476 and OPPTS 870.5300
GLP compliance:
yes
Type of assay:
in vitro mammalian cell gene mutation tests using the thymidine kinase gene

Test material

Constituent 1
Reference substance name:
Dodecane-1-thiol (CAS # 112-55-0)
IUPAC Name:
Dodecane-1-thiol (CAS # 112-55-0)

Method

Target gene:
TK+
Species / strain
Species / strain / cell type:
other: L5178 TK+/- lymphoma cell
Metabolic activation:
with and without
Test concentrations with justification for top dose:
30, 20.1, 13.5, 9.0, 6.0, 4.0, 2.7, and 1.8 µg/mL
Vehicle / solvent:
Solvent control used
Controls
Untreated negative controls:
yes
Positive controls:
yes
Remarks:
ethylmethane sulfonate (620 ug/ml) without metabolic activation and 3-methylholanthrene (3 ug/ml) with metabolic activation
Positive control substance:
3-methylcholanthrene
ethylmethanesulphonate

Results and discussion

Test results
Key result
Species / strain:
other: mouse lymphoma L5178Y cells mammalian cell line
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: other: Acceptable growth inhibition exhibited at 30 ug/ml.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not measured/tested

Any other information on results incl. tables

Cells  exposed to eight  graded  doses of test substance with and  without  metabolic  activation  did  not  exhibit  a dose-dependednt increase in mutation frequency at the TK +/- locus. A test was considered positive if dose-related response at two or more test concentrations is at least two or three-fold higher than mutation frequency of solvent control.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: Negative
Executive summary:

In a mammalian cell gene mutation assay focused on the T/K locus, L5178Y Mouse Lymphoma cells cultured in vitro were exposed to dodecane-1-thiol at concentrations at 1.8, 2.7, 4.0, 6.0, 9.0, 13.5, 20.1, and 30.0 µg/mL in the presence and absence of mammalian metabolic activation.    
 
Concurrent  positive  controls  were  ethylmethane  sulfonate  (620  ug/ml)  without  metabolic activation  and  3-methylcholanthrene  (3  ug/ml)  with  metabolic  activation.  A  negative and solvent control were also run concurrently. Under experimental conditions, dodecane-1thiol did not
exhibit a positive response and is considered to be not mutagenic in this test system. This study received a Klimisch score of 1 and is classified as reliable without restriction because the study adhered closely to OECD guidelines.