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Administrative data

Description of key information

Based on the repeated human patch test, no effects were observed on the subjects due to the test item.

Based on the human repeated insult patch test, there is no evidence of skin sensitation potential casued by the test item.

Additional information

Repeated Human Patch Test

A human sensitization test was conducted with a shampoo formulation (G3454.01) containing 3.5% sodium launminodipropionate (concentration is expressed here as active: the ingredient was added at 11.67% and consisted of —30% sodium launminodipropionate). The formulation was tested as a 2.5% solution in distilled water. 0.5 mL of the test article was applied to a webril disc. One hundred and sixteen subjects completed the study. Under the conditions of this study, there was no evidence of delayed contact hypersensitivity to the shampoo formulation containing 3.5% sodium lauriminodipropionate. One subject (panelist 54) had mild to moderate erythematous reactions during induction and a response at challenge at the original site at both 48 and 96 hour scoring that warranted further follow-up. This subject was re-challenged by applying the original test formulation (G3454.01), with a similar shampoo formulation also containing 3.5% sodium lauriminodipropionate (G3544.01) (both tested as 2.5% solutions in distilled water), and with the fragrance used in G3454.01 (test material G3543.01) (tested at 0.4% in mineral oil) to both the original arm and the alternate arm. The only response at re-challenge was mild erythema to shampoo formulation at the 48 hour scoring on the original arm. This response had returned to normal (grade 0) by the 96 hour scoring. Mild erythematous reactions were reported in a number of other subjects during the induction phase and during the challenge. Responses to these subjects including in panelist 54 were judged to be irritant and consistent with the nature of the test material (i.e., a surfactant containing shampoo) (North Cliff Consultants Inc., 1992).

Human repeated insult patch test

A human repeated insult patch test (HRIPT) study was conducted with two test materials, one of which (MV#2764- 178) was a foaming face wash formulation containing 2.2% sodium lauriminodipropionate (concentration is expressed here as active; the ingredient was added at 7.34% and consisted of -30% sodium lauriminodipropionate). The formulation was tested as a 2.0% (w/v) solution in distilled water. 0.2 mL of the test article was applied to a 2 x 2 cm patch. One hundred and four subjects completed the study. Under the conditions employed in the study, there was no evidence of sensitisation (TKL Research Inc., 1991).