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:

The GPMT test yielded a clear positive result for undiluted NIKKOL VC-IP.

The human patch tests (included in section 7.10.4) were performed with low concentrations (5 and 10%), therefore the results are not considered applicable for the undiluted substance. Systemic exposure to the substance may not have occurred; volunteers might not sufficiently be induced by the test substance, limiting the acceptability of these studies for evaluation of the skin sensitizing properties of NIKKOL VC-IP. These data might be more appropriate for evaluation of the skin sensitizing potential of end-use products.

Therefore, the available negative human patch tests cannot nullify the positive GPMT test. It should therefore be concluded that NIKKOL VC-IP needs classification with H317.


Migrated from Short description of key information:
In a GPMT test performed according to OECD 406 NIKKOL VC-IP was a skin sensitizer.

Justification for classification or non-classification

Based on the available information, NIKKOL VC-IP is classified according to CLP 1272/2008.

Categories Display