Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a LLNA performed according to OECD 429 Guideline and in compliance with GLP, groups of CBA/J mice (4 females/dose) were exposed to 25 µL

of nopyl acetate in Acetone/Olive oil (4/1, v/v) at concentrations of 0 (vehicle control), 5, 10, 25, 50 and 100 % (v/v) to the dorsal surface of both ears for three consecutive days.

No clinical signs and no mortality were observed during the main test. No local reactions and no notable increase in ear thickness were observed at any of the tested concentrations. Stimulation Index for 5, 10, 25, 50 and 100% was 0.73, 1.44, 7.14, 3.61 and 3.63, respectively. The calculated effective concentration inducing a SI of 3 (EC3) was 14.11 %. A significant lymphoproliferation (SI > 3) was noted at concentrations ≥ 25%. In the absence of local irritation, the significant lymphoproliferative responses observed were attributed to delayed contact hypersensitivity.

Therefore, nopyl acetate was considered as skin sensitising.

Migrated from Short description of key information:
Nopyl acetate induced skin sensitisation in a Local Lymph Node Assay (LLNA): EC3 = 14%.

Justification for selection of skin sensitisation endpoint:
Only one study available for this endpoint

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Nopyl acetate induced positive response in a LLNA with an EC3 = 14%, therefore it is classified as sensitising "R43: may cause sensitisation by skin contact" according to Directive 67/548/EEC and skin sensitiser Category 1B according to CLP Regulation (EC) No 1272/2008.

Categories Display