Potassium dodecyl sulphate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

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

Reference Type:

review article or handbook

Title:

Reverse bacterial mutation assay for Sodium Dodecyl Sulfate

Author:

U. S. National Library of Medicine

Year:

2017

Bibliographic source:

CCRIS - Chemical Carcinogenisis Research Information System, US national Library of Medicine reviewed by SRC, 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

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

Test material information

Constituent 1

Reference substance name:

Sodium dodecyl sulphate

EC Number:

205-788-1

EC Name:

Sodium dodecyl sulphate

Cas Number:

151-21-3

Molecular formula:

C12H25NaO4S

IUPAC Name:

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

Method

Target gene:

Histidine

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
- Vehicle(s)/solvent(s) used: Distilled water

Controls

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.

Statistics:

Not specified.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 98, TA100, TA1535 and TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

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

Conclusions:

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.