L-Arginine, N2-(2,3-dihydroxypropyl)-, monohydrochloride

Endpoint summary

Description of key information

Non-irritant and non-sensitising to the skin under occlusive conditions in RIPT (E. Dubenskaya, M.D; 2005).

Additional information

STUDY OBJECTIVE

To prove the absence of the skin sensitisation potential of a product applied to the skin, under maximized conditions, with controlled product amount and application site, supervised by a dermatologist.

 

METHODOLOGY

As per client requests, the test material K-7470 was diluted to 16.66% in distilled water. Dilutions were freshly prepared on each application day. 0.2 ml or 0.2 g of the test material is dispensed onto the occlusive, hypoallergenic patch.  The patch is then applied directly to the skin of the intrascapular regions of the back, to the right or left of the midline and the subject is dismissed with instructions not to wet or expose the test area to direct sunlight.  After 24 hours the patch is removed by the panellist at home.  This procedure is repeated until a series of consecutive 24 hour exposures have been made for every Monday, Wednesday, and Friday for three consecutive weeks. In the event of an adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. In most instances this is approximately 24 hours after patch removal. Clients are notified immediately in the case of adverse reaction and determination is made as to treatment program if necessary. Subjects are given a 10 -14 day rest period after which a challenge or retest dose is applied once to the previously unexposed test site. The retest dose is equivalent to any one of the original nine exposures. Reactions were scored 24 and 48 hours after application. Comparison is made between the nine inductive responses and the test dose.  

 

STUDY LENGTH

6 weeks.

 

FREQUENCY OF APPLICATION

9 applications on the 3 first weeks (induction period).

1 application on the last week (challenge period).

 

APPLICATION SITE

Back (Scapular area).

 

NUMBER OF SUBJECTS

52 subjects completed the study.

 

POPULATION DESCRIPTION

Female and male, age range from 18 to 69 years old.

 

ETHICS

This study was conducted in conformance with the Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, Published by the Association of Food and Drug Official of The United States.

 

RESULTS

During the study, no subjects presented skin clinical signs related to the product.

 

CONCLUSION

The test material  did not induce a skin sensitisation process in the study group when tested under occlusion at a 16.66% diluted in distilled water.

Therefore, the test material  was considered as a non-irritant and non-primary sensitiser to the skin according to the reference (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, Published by the Association of Food and Drug Official of The United States).