Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The aim of the study was to evaluate the possible allergenic activity of the test item LUGALVAN BPC dry after topical administration in guinea pigs (PHYCHER Bio developpement, 2013). After induction of 20 guinea-pigs by 3 topical applications with the test item LUGALV AN BPC dry applied diluted at 70% in distilled water under occlusive dressing and a 14-day rest phase, the challenge phase, under occlusive dressing for 6 hours, consisted to a single topical application of the test item diluted at 50% in distilled water and of a negative control (distilled water). The experimental protocol was established from the O.E.C.D. guideline n°406 dated July 17th, 1992, the method B.6 of the Council regulation No. 440/2008 and the US EPA OPPTS guideline 870.2600 (March 2003). The study was conducted according to GLP. No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item at 50%. No cutaneous intolerance reaction was recorded in animals from the negative control group. In conclusion, in view of these results, under these experimental conditions, the test item LUGALV AN BPC dry shows no skin sensitisation potential.

Migrated from Short description of key information:
Buehler-Test (OECD 406): not sensitizing (PHYCHER Bio developpement, 2013)

Justification for classification or non-classification

Based on the available data, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP) for skin sensitization.