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:

Based on the positive results of LLNA study the test substance may be a potential contact allergen, but the irritation effect observed does not rule out the possibility that it may be a false positive result.

 


Migrated from Short description of key information:
The Local Lymph Node Assay (LLNA) with radionuclides was used. The testing was conducted according to the EU Method B.42, Skin sensitization: Local Lymph Node Assay, Council Regulation (EC) No. 440/2008, published in O.J. L142, 2008.
GLP study

Justification for classification or non-classification

On the basis of LLNA test results, the subsatnce Tar, brown-coal, low-temp. - should be classified as skin sensitising substance - Skin Sens. 1; H317 May cause an allergic skin reaction - according to Regulation (EC) No 1272/2008 criteria (R43 May cause sensitisation by skin contact - according to DSD criteria).