Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Migrated from Short description of key information:
The substance as described in Section 1.2 contains approx. 30% of benzene-1,2,4-tricarboxylic acid 1,2-anhydride, CAS 552-30-7 / EC 209-008-0. This substance is classified for skin sensitisation (class 1). Therefore testing has not been done and classification for skin sensitisation of benzene-1,2,4-tricarboxylic acid 1,2-anhydride applies also to the substance as described in Section 1.2

Respiratory sensitisation

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

The sensitisation potential of benzene-1,2,4-tricarboxylic acid 1,2-anhydride (TMA), which is a major component of about 30% in the substance as described in Section 1.2 is likely to cause respiratory sensitisation in exposed subjects as well. It may be relevant that TMA is a fine powder and the substance as described in Section 1.2 is manufactured and used as flakes. However, flakes are known to be broken up by shearing forces. This results in smaller particles, which are partially (depending on the strenght and duration of shearing forces) respireable.


Migrated from Short description of key information:
The substance as described in Section 1.2 contains approx. 30% of benzene-1,2,4-tricarboxylic acid 1,2-anhydride, CAS 552-30-7 / EC 209-008-0. This substance is classified for respiratory sensitisation (class 1). Therefore testing has not been done and classification for respiratory sensitisation of benzene-1,2,4-tricarboxylic acid 1,2-anhydride applies also to the substance as described in Section 1.2

Justification for classification or non-classification

The substance is classified with Resp. Sens 1, H334 and Skin Sens 1, H317 due to the fact that significant amount, typically 30%, of the substance contains TMA, which is classified as Resp. Sens 1, H334 and Skin Sens 1, H317