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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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1984-09-24 to 1985-01-02
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This publication is classified as reliable with restrictions because while it is an acceptable and a well-documented study report following basic scientific principles, no data on GLP was provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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: Oily liquid
Details on test material:
- Name of test material (as cited in study report): Primol 185 (GOO2)

Method

Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Test concentrations with justification for top dose:
10, 50, 100, 500 and 1000 μg/ml with and without activation
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
Evaluation criteria:
A test material was considered positive if it yielded a 2-fold increase over the spontaneous mutant frequency of controls at one dose level or more.
Statistics:
For each dose group, the total colony counts from each VC and TFT plate was recorded. Relative and total cloning growth, mutant frequency and induced mutant frequency were then calculated from this information.

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:
not applicable
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

Highly refined base oil was found to be negative with and without metabolic activation.
Executive summary:

In a mammalian cell gene mutation assay, mouse lymphoma L5178Y cells cultured in vitro were exposed to a highly refined base oil at concentrations of 10, 50, 100, 500 and 1000 μg/ml with and without metabolic activationfor three hours.

The dosing period was three hours followed by two day expression period for the test and control cultures. Triplicate cultures, cloned in selective medium, were then incubated for ten to twelve days. Surviving and mutant colonies were then counted on a colony counter and the mutation frequencies were calculated. The positive controls did induce the appropriate response.  Highly refined base oil was found to be negative with and without metabolic activation.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because while it is an acceptable and a well-documented study report following basic scientific principles, no GLP data was provided.