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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: no informtion on GLP. Study report lacks some details but nevertheless provides useful supporting information

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
Diesel fuel

Method

Target gene:
L5178Y mouse lymphoma cells
Test concentrations with justification for top dose:
0.125, 0.188, 0.25, 0.375, 0.5 uL/ml - non activation study
0.064, 0.125, 0.188, 0.25, 0.375, 0.5 uL/ml - activation study
Vehicle / solvent:
acetone
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
ACETONE
Positive controls:
yes
Positive control substance:
other: ethylmethane sulphonate and dimethyl nitrosamine
Details on test system and experimental conditions:
L5178Y MOUSE LYMPHOMA CELLS

Results and discussion

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

Diesel fuel was not mutagenic in the mouse lymphoma assay
Executive summary:

The genotoxic activity of diesel fuel was evaluated in a mouse lymphoma assay using L5178Y cells. Assays both in the presence and absence of a mouse liver mirosome fraction were conducted. Dose levels ranged between 0.064 and 0.5 uL/ML.

Results showed no evidence of of genotoxic activity, either in the presence or absence of metabolic activation. The positive control materials both showed expected results.