Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 290-476-8 | CAS number: 90170-43-7
- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Reported in Cosmetic Ingredient Review, 1992 Study performed on Sodium Lauriminodipropionate Primary data not seen, but review considered valid
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Groups of 10 Guinea Pigs were injected 0.1% solutions for a total of 10 injections over 20 days induction period
The animals were rested for two weeks with no treatment and a challenge dose injected near the induction sites. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- EC Number:
- 239-032-7
- EC Name:
- Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate
- Cas Number:
- 14960-06-6
- Molecular formula:
- C18H35NO4Na
- IUPAC Name:
- sodium 3-[(2-carboxyethyl)(dodecyl)amino]propanoate
- Test material form:
- other: dilute solution in water
- Details on test material:
- Used in water at concentration of 0.1%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 10
- Challenge controls:
- Not reported
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse effects reported
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 0.1 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effects reported.
Any other information on results incl. tables
No evidence of sensitisation observed
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No evidence of sensitisation observed
- Executive summary:
No evidence of sensitisation observed
Even when considering the absence of key data in the published report, the conclusions made at the time by those undertaking the review are that the substance can be used in dermally applied cosmetic products. Human monitoring is also reported and no evidence of sensitising effects is reported.
No claims for data ownership are made and it is noted that the review relied on data from industry testing on similar substances.
There is no justification to perform further animal tests on this substance, especially in regard to its use in cosmetic products.
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