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:

An increase in cell proliferation of draining lymph nodes, statistically significant at the highest concentration, was observed in all dose groups, with a Stimulation Index of 2.21, 1.84 and 2.87 at the low, medium and high dose (2.5 %, 5 % and 10 %), respectively.

The lack of dose-relation was ascribed to inhomogeneous values of absorbance within Group 3. An abnormally high value for animal no. 41 of Group 4 (Replicate 1) was also observed. Nevertheless, values of SI were above the threshold of 1.6 for all treated groups.

In the group treated with the positive control item, a Stimulation Index of 9.30 was calculated. As it was greater than 2, the study was regarded as valid.


Migrated from Short description of key information:
The potential of the test item, V516690, to cause skin sensitisation reactions following topical application to the skin of CBA/JN (CBA/J) mice, was assessed using the LLNA:BrdU-ELISA method, according to the OECD Guideline for testing of chemicals no. 442b. An increase in cell proliferation of draining lymph nodes was observed in all treatment groups. The calculated Stimulation Indices were 2.21, 1.84 and 2.87 at low, mid- and high dose levels, respectively.

Justification for classification or non-classification

European legislation concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:

Classification : Category 1 ;

Signal word: Warning ;

Hazard statement: H317: May cause an allergic skin reaction