Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

The test substance Vinyl-2-ethylhexanoate (VEHA) was assessed for the potential to induce skin sensitization in an O.E.C.D. test guideline 429 mouse Local Lymph Node Assay (LLNA) with GLP compliance. The test substance VEHA was positive for skin sensitization in the O.E.C.D. test guideline 429 mouse LLNA study. VEHA induced a Stimulation Index (SI) of 3-fold at a concentration of 50 % v/v. Undiluted VEHA induced an SI of approximately 5.1. The EC3 concentration value was approximately 50 % v/v. Classification and Labeling as a skin sensitizer is required under the GHS and EU CLP and DSD.


Migrated from Short description of key information:
The test substance Vinyl-2-ethylhexanoate (VEHA) was positive for skin sensitization in the O.E.C.D. test guideline 429 mouse LLNA study. VEHA induced a Stimulation Index of 3-fold at a concentration of 50 % v/v. The EC3 concentration value wasapproximately 50 % v/v.

Justification for selection of skin sensitisation endpoint:
Positive skin sensitizing result in an O.E.C.D. test guideline 429 mouse Local Lymph node Assay.

Justification for classification or non-classification

Based on the findings of an O.E.C.D. test guideline 429 mouse LLNA, the substance meets the criteria for a skin sensitizer as per Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures.