Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 290-476-8 | CAS number: 90170-43-7
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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
