Registration Dossier
Registration Dossier
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EC number: 222-581-1 | CAS number: 3539-43-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- The substance that has been tested for this end point is the potassium salt of lauryl phosphate, which has a carbon chain length of 12 C instead of 16C.
Potassium lauryl phosphate was not mutagenic in the Ames test. This substance is a slightly shorter chain length than potassium cetyl phosphate, the K salt of the substance being registered. According to the CIR review for these type of substances, no alkyl phosphates that were tested appeared to exhibit any genotoxicity
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Remarks:
- GLP details are not specified in the CIR review
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phosphoric acid, dodecyl ester, potassium salt
- EC Number:
- 254-414-3
- EC Name:
- Phosphoric acid, dodecyl ester, potassium salt
- Cas Number:
- 39322-78-6
- Molecular formula:
- C12H26KO4P
- IUPAC Name:
- potassium dodecyl hydrogen phosphate
Constituent 1
- Specific details on test material used for the study:
- None given
Method
- Target gene:
- S. typhimurium: ≤2500 μg/plate without and ≤5000 μg/plate with metabolic activation
Escherichia coli: ≤5000 μg/plate with and without metabolic activation
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Vehicle / solvent:
- Deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Potassium lauryl phosphate was not mutagenic in the Ames test. This substance is a slightly shorter chain length than potassium cetyl phosphate, the substance being registered.
According to the CIR review for these type of substances, no alkyl phosphates that were tested appeared to exhibit any genotoxicity
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