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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

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.

There is no justification to perform further animal tests on this substance, especially in regard to its use in cosmetic products.

Human data (presented to CIR expert panel meeting December 12-13, 2011) :

Sodium lauriminodipropionate was reported to be “practically nontoxic” to the skin and “minimally irritating” upon skin contact. It was also reported to be “minimally irritating” to the eye. Sodium lauriminodipropionate was “practically nontoxic” upon ingestion. From the Final Report on the Safety Assessment of Sodium Lauriminodipropionate.

1 A human repeat insult patch test (HRIPT) of the potential of 2.2% sodium lauriminodipropionate (7.34% of 30% solution) to induce contact sensitization was conducted using 104 subjects.20 The subjects received 0.2 ml applications of a 2.0% foaming face wash solution in distilled water. Induction applications were made to the infrascapular region of the back with a 2 cm2 Webril pad portion of an adhesive dressing. The test sites were occluded. The patches were removed after 24 h and there were 9 consecutive applications. Following 2 week nontreatment period, the challenge application was applied to a previously untreated site for 24 h, and the site was scored 24 and 48 h after patch removal. During the induction phase, there were as few as 3 (days 1and 2) and as many as 39 (day 9) “?”responses (doubtful response, barely perceptible erythema). There were no other responses during the induction phase. In the challenge phase, there were 8 and 7 “?” responses at 24 h and 48 h after patch removal, respectively. There were no other responses during the challenge phase. The study concluded that there was no evidence of sensitization to a foaming face wash formulation containing 2.2% sodium lauriminodipropionate. In another HRIPT, the potential of 3.5% active sodium lauriminodipropionate (11.67% of a 30% solution) to induce contact sensitization was studied in 116 subjects.

2 The subjects received 0.5 ml applications of 2.5% shampoo formulation solution in distilled water. Induction applications were made to the arm with a 7/8 inch diameter Webril disc secured with adhesive dressing. The test sites were occluded. The patches were removed after 24 h and there were 9 consecutive applications. Following 2 week non-treatment period, the challenge application was applied to a previously untreated site for 24 h, and the site was scored 48 and 96 h after application. One subject had mild to moderate erythema during the induction and had a positive response at challenge in the original test site. The subject subsequently underwent rechallenge patching with the test material, with a 2.5% w/v aqueous solution of another shampoo formulations containing 3.5% sodium lauriminodipropionate, and a 0.4% w/v solution of the fragrance used in the original test formulation in mineral oil. Mild erythema was observed to the similar shampoo formulation at the 48 h scoring, which resolved completely at the 96 h scoring. No other responses were observed in this subject. Mild erythematous reactions were reported in several other subjects during the induction phase as well as during challenge. These reactions, and the ones observed in the subject that underwent rechallenge, were determined to be irritant responses consistent with surfactant use. The study concluded that there was no evidence that the shampoo formulation containing 3.5% sodium lauriminodipropionate caused delayed contact hypersensitivity.

Migrated from Short description of key information:

Following intradermal induction and challenge, no evidence of sensitisation was seen in guinea pigs.

Justification for selection of skin sensitisation endpoint:

Report on maximised study

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Negative skin sensitisation and typically supplied and used in non-inhalable form.