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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:
Data is from peer reviewed journal.

Data source

Reference Type:
review article or handbook
Reverse bacterial mutation assay for Sodium Dodecyl Sulfate
U. S. National Library of Medicine
Bibliographic source:
CCRIS - Chemical Carcinogenisis Research Information System, US national Library of Medicine reviewed by SRC, 2017

Materials and methods

Test guideline
according to guideline
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of Sodium Dodecyl Sulfate in Salmonella typhimurium TA 98, TA100, TA1535 and TA 1537 by reverse mutation assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dodecyl sulphate
EC Number:
EC Name:
Sodium dodecyl sulphate
Cas Number:
Molecular formula:
Sodium dodecyl sulfate
Details on test material:
- Name of test material : Sodium Lauryl Sulphate (sodium dodecyl sulphate)
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
Name of test material (as cited in study report): Sodium Dodecyl Sulfate
- Molecular formula: C12H25NaO4S
- Molecular weight: 288.3815g/mol
- Substance type: Organic


Target gene:
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
RAT LIVER, S-9, AROCLOR 1254 (10%), HAMSTER LIVER, S-9, AROCLOR 1254 (10%)
Test concentrations with justification for top dose:
Without S9- 3-333 µg/plate
With S9- 10-1000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Distilled water
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: Preincubation method
Rationale for test conditions:
Not specified.
Evaluation criteria:
Evaluation was done considering a dose dependent increase in the number of revertants/plate.
Not specified.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 98, TA100, TA1535 and TA 1537
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Not specified
Remarks on result:
other: No mutagenic effect were observed.

Applicant's summary and conclusion

When Sodium Dodecyl Sulfate (151-21-3) was observed for its mutagenic potential in salmonella typhimurium TA 98, TA100, TA1535 and TA 1537. Sodium Dodecyl Sulfate did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
Executive summary:

In a reverse gene mutation assay on Salmonella typhimurium strain TA 98, TA100, TA1535 and TA 1537. The bacterial strains were exposed to Sodium Dodecyl Sulfate at concentration of 10-1000 µg/plate in the presence of S9 metabolic activation. While the concentration were 3-333 µg/plate in the absence of mammalian metabolic activation. No mutagenic effects were observed in all tested strains with and without metabolic activation. Therefore Sodium Dodecyl Sulfate cannot be considered as mutagenic in vitro in salmonella typhimurium TA 98, TA100, TA1535 and TA 1537. Hence it cannot be classified as gene mutant in vitro.