Registration Dossier

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:

Comparison of values between treated groups and control group revealed that the test substance did not cause statistically significant increase in LN cell count or in LN weight. Also index of LN weight and LN cell count was not exceeded in any dose level.

In conclusion, at the given experimental conditions the test substance elicited negative result in LLNA test.


Migrated from Short description of key information:
EU method B.42 with modifications as described in publications of Ulrich P, Streich J, Suter W, 2001; Ehling et al., 2005; Ehling et al., 2005A.
(non Radioactive measuring of cell proliferation). Validated method.
GLP study

Justification for classification or non-classification

From the results of the LLNA study follows that the substance has no skin sensitising properties and therefore it is not classified as sensitizing substance.