β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

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:

1997

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

Test material information

Constituent 1

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%

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

water

Induction 2

Concentration / amount:

0.1%

Challenge

Challenge 1

Route:

intradermal

Vehicle:

water

Challenge 2

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.