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EC number: 939-529-5 | CAS number: 1471313-51-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor 1254 pretreated rats
- Test concentrations with justification for top dose:
- 4 up to 5000 microgram / plate
- Vehicle / solvent:
- Aqua bidest
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Evaluation criteria:
- 2-fold increase in mean number of revertants per plate
Dose-related increase in mean number of revertants per plate - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
ambiguous without metabolic activation
Based on the study results of this bacterial mutagenicity assay (Ames test), sodium cocoyl taurate is not muatgenic neither in the presence or absence of metabolic activation. - Executive summary:
Sosium cocoyl taurate was tested for mutagenicity with the strains TA 100, Ta 1535, TA 1537, and TA 98 of Salmonella typhimurium. The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. The test substance was dissolved in Aqua bidest and a dose range of 6 different doses from 4 microgram/plate to 5000 microgram/plate was used. Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literaure. All the positve control compounds gave the expected increase in the number of revertant colonies. In the cytotoxicity tests, the test item proved to be toxic to most of the bacterial strains at doses of 2500 microgram/plate and above. In the mutagenicity study, 5000 microgram/plate was chosen as top dose level which did not result in any relevant (dose-dependent) increase in the number of revertants in any of the bacterial strains tested, neither in the preence nor in the absence of metabolic activation. On the basis of the results of this study, it can be stated that sodium cocoyl taurate is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose lebvels investigated.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The registration substance was tested for potential point mutation in a guideline conform bacterial reverse mutation assay (Ames test) according to OECD TG 471 with and without metabolic activation. Independent experiments using several test concentrations up to the limit dose of 5000µg/platedid not cause gene mutations by base pair changes or frameshifts in the genome of any of the tester strains used. Therefore, the submission substance is considered to be non-mutagenic in this bacterial reverse mutation assay. This study was selected as key study.
The registration substance was tested for potential gene mutation in a guideline conform mouse lymphoma assay (HPRT locus) according to OECD TG 476 in L5178Y cells. Using independent experiments, no biologically relevant increase of mutants was found after treatment with the test item, neither with nor without metabolic activation. No dose-response relationship was observed. Therefore, the submission substance is considered to be non-mutagenic in the mouse lymphoma assay. This study was selected as key study.
The registration substance was tested for the potential to induce micronuclei in human lymphocytes in vitro in tha absence and presence of metabolic activation. Several dose levels up to 320 µg/mL and two exposure periods (4 and 20 hours) were tested. No biologically increase of micronuclei was found, either with or without S9 -mix. No dose-response relationship was observed. Therefore the submission substance is considered to be non-mutagenic in the micronucleus test in vitro. This study was selected as key study.
Additionally, supporting evidence concerning the absence of genotoxic / mutagenic properties is coming from study results with the structural analogue sodium methyl oleyl taurate, which was not muatgenic in the Ames test, the mammalian cell gen mutation assay (HPRT) and the cytogenetic in vitro test in V79 mammalian cells.
In conclusion, the registration substance is found to be not genotoxic / mutagenic in various test systems. This conclusion is further supported by read-across to data from a structural closely related compound.
Justification for selection of genetic toxicity endpoint
There are several key studies covering bacterial point mutation testing, testing for gen mutations in mammalian cells as well as chromosome mutations in mammalian cell systems. All studies are performed on the registration substance and representing guideline conform tests according to GLP with a Klimisch rating of 1. Additionally, study results from the read-across analogue sodium methyl oleyl taurate are in line and confirm above conclusions.
Justification for classification or non-classification
Based on the available data from three independent mutagenicity assays and supported by data from a structural analogous compound, a respective mutagenic potential of the test item can be excluded. Thus, the registration substance does not have to be classified for mutagenicity in accordance with the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) as well as in the EU Classification, Labellling and Packaging Regulation (1272/2008/EC).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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