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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
no
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
Sodium dodecyl sulphate
EC Number:
205-788-1
EC Name:
Sodium dodecyl sulphate
Cas Number:
151-21-3
IUPAC Name:
sodium dodecyl sulfate
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
- Storage condition of test material: No data

Method

Target gene:
Thymidine kinase locus (tk)
Species / strain
Species / strain / cell type:
mouse lymphoma L5178Y cells
Additional strain / cell type 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 / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: methylmethanesulfonate, ethylmethanesulphonate
Details on test system and experimental 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 / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative 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

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

No enhanced mutation rate in the S9 treated or untreated cells was observed in this mouse lymphoma assay. Therefore, the test substance was not considered to be mutagenic.