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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
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near guideline study. GLP status unknown, Minor restrictions in design and reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Principles of method if other than guideline:
Evaluation for specific locus forward mutation induction in the L5178Y Thymidine Kinase (TK) mouse lymphoma cell.
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): toluene
- Physical state: colourless liquid

Method

Species / strain
Species / strain / cell type:
other: TK locus in cultured L5178Y mouse lymphoma cells.
Metabolic activation:
with and without
Metabolic activation system:
co-factor supplemented post mitochondrial fraction (S9) from mouse liver
Test concentrations with justification for top dose:
0.05, 0.10, 0.15, 0.20 and 0.30 µL/mL
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: ethylmethanesulphonate (0.5 µL/mL without activation) , N-dimethylnitrosamine (0.5 µL/mL with activation)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 3 days

NUMBER OF REPLICATIONS: 3

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative 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

Toluene was not mutagenic in the mouse lymphoma assay (with or without metabolic activation).
Executive summary:

Toluene was not mutagenic in the mouse lymphoma assay (with or without metabolic activation). All data were within the expected range of the spontaneous background.