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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Response of the L5178Y tk+/tk- mouse lymphoma cell forward mutation assay: III. 72 Coded chemicals
Author:
McGregor et al.
Year:
1988
Bibliographic source:
Environmental and Molecular Mutagenesis 12:85-154 (1988)
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
GLP compliance:
no
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): Sodium dodecyl suphate
- Physical state: no data
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no ata

Method

Target gene:
Thymidine kinase locus (tk)
Species / strain
Species / strain:
mouse lymphoma L5178Y cells
Additional strain characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
-S9: 3.125, 6.25, 10, 12.5, 20, 25, 30, 40, 50, 55, 60,65, 70, 80 and 100 µg/mL
+S9: 50, 55, 60, 65, 70, 75, 80, 85, 90 and 95 µg/mL
Vehicle:
DMSO
Controls
Negative controls:
yes
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: methylmethanesulfonate, ethylmethanesulphonate
Details on test system and conditions:
METHOD OF APPLICATION: in medium
Evaluation criteria:
According to guideline.
Statistics:
Yes.

Results and discussion

Test results
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
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

The test item was not considered to be mutagenic.
Executive summary:

No increase in the mutation rate in the treated cells, either with or without metabolic activation, was observed in this mouse lymphoma assay. Therefore, the test substance was considered to be non-mutagenic.