Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 282-001-8 | CAS number: 84082-55-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lupinus albus, Leguminosae.
Endpoint summary
Administrative data
Description of key information
No reaction observed during the induction and the challenge phases in a repeat insult patch test with test item on 113 volunteers.
No irritation in 11 volunteers after single application of 0.02 mL of the product for 48 h in occlusive patch test.
Additional information
A panel of 113 men and women human volunteers participated in a repeat insult patch test in which a test item applied as such, to the back of the subjects under occlusive patches. 112 subjects completed the study. During the induction phase 9 patches were applied, separated by a 48 h interval. The patches were removed 48 h after application. Following 2 weeks rest period, a challenge patch was applied and the sites scored 30 minutes, 48 and 72 h after application.
No reaction were observed during the induction and the challenge phases.
Under the conditions employed in this study, the test item did not induce clinically significant skin irritation nor show any evidence of induced allergic contact dermatitis. The test item can be considered as "hypoallergenic".
In a single patch test, 11 volunteers (men and women) from 19 to 41 years of age, with a normal skin, without any dermatological lesion on the experimental area, have been included in the study. Single application of 0.02 mL of the test item, on the external face of the arm, maintained for 48 h in contact with the skin, with the help of an occlusive patch (Haye's-Chambers).
11 volunteers have been included and were analyzed. The average irritation index is 0.
Under the conditions employed in this study, test item wasconsidered as non-irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
