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

Endpoint summary

Description of key information

In vitro skin sensitisation: Waived

In vivo skin sensitisation: Waived

Human skin sensitisation test (RIPT) (see Section 7.10.4): Negative for skin sensitisation

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. Available data to fulfil this endpoint were obtained from a Repeat Insult Patch Test Skin Irritation/Sensitisation study (RIPT) conducted on N-Glyceryl Arginine HCI.

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. Available data to fulfil this endpoint were obtained from a Repeat Insult Patch Test Skin Irritation/Sensitisation study (RIPT) conducted on N-Glyceryl Arginine HCI.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

HRIPT - human skin sensitisation test (2005)

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 0.2g 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 exposed 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 9 consecutive 24 hour exposure 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).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test item does not meet the criteria for classification according to the Globally Harmonized Classification System or for the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.