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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Under the conditions of a repeated insult (occlusive) patch test procedure conducted in a panel of 112 subjects, with all types of skin, the product "Dermatologist-Tested" and did not induce clinically significant skin irritation nor show any evidence of induced allergic dermatitis in human subjects.
The product can be considered as "hypoallergenic".
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- Data on human volunteers are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A panel of 113 men and women human volunteers participated in a repeat insult patch test in which a test product 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 nor the challenge phase.
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".
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a human repeat insult patch test, the test item was concluded to be hypoallergenic. Based on this result and due to the nature of the main constituents of the registered substance (proteins from Lupinus Albus seeds), the registered substance does not need to be classified as skin sensitiser.
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.
