Registration Dossier

Administrative data

Description of key information

The test substance is irritating to skin. It is not irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation of the test substance is described with an weight-of evidence approach. Two in vivo studies with test substance mixtures (1983: 45% Ni(TTP)4, 35% free TTP, slightly irritating; 1982: 10% Ni(TTP)4, 10% free TTP, moderately irritating) and one in vivo study with the main component of the test substance, the ligand TTP (1969; highly irritating) are available. Based on these data, the test substance is considered to be a skin irritant.

Eye irritation: A guideline study with the ligand TTP revealed only minimal signs of irritation in the eyes of rabbits. Based on this result, the submission substance, which is expected to rapidly release TTP, is not considered to be an eye irritant.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The available data for skin irritation of the test substance are not detailed enough to apply the classification criteria of REGULATION (EC) 1272/2008 for skin irritation. As a conservative approach, the submission substance needs to be classified for skin irritation of category 2 according to REGULATION (EC) 1272/2008, based on the results of the available studies.

 

Based on the results of a reliable eye irritation study with the ligand TTP, the submission substance does not have to be classified for eye irritation according to the REGULATION (EC) 1272/2008.