Hydrocarbons, C5-8

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Toluene

EC Number:

203-625-9

EC Name:

Toluene

Cas Number:

108-88-3

Molecular formula:

C7H8

IUPAC Name:

toluene

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.