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:

Four skin sensitisation studies, all according to Magnusson and Kligman, have been performed of which three have been performed according to OECD test guideline 406 and GLP principles. Different concentrations were used for induction and challenge, ranging from 0.1 -0.01% for induction, 75 -100% for topical induction and 7.5 -100% for topical challenge. When challenged with 75 -100% substance, also the control animals showed irritation resulting in rechallenge with a 25 -50% solution. All studies showed a clear positive response in sensitisation, all animals were sensitised. Positive and negative controls showed the validity of the study. Therefore, XDI is considered to be a skin sensitiser (sub-category 1A).


Migrated from Short description of key information:
In four guinea-pig skin maximisation tests, performed according to test guidelines, XDI showed to be a skin sensitiser with all exposed animals responding positively.

Justification for selection of skin sensitisation endpoint:
There are 4 studies available. Two studies have Klimisch score 1 and two have Klimisch score 2. As all these reliable studies showed a clear positive response in sensitisation (all animals were sensitised), no specific study is selected.

Respiratory sensitisation

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

In accordance with the ECHA Guidance document "Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance"of May 2008 (page 258 - 290), diisocyanates need to be considered for classification as a respiratory sensitiser. In the scientific literature diisocyanates are identified as chemicals causing the development of occupational asthma after workplace exposure. The available data does not show that such a classification is not warranted for XDI.


Migrated from Short description of key information:
Diisocyanates need to be considered for classification as a respiratory sensitiser because in the scientific literature diisocyanates are identified as chemicals causing the development of occupational asthma after workplace exposure. For XDI there is no data available that shows that such a classification is not warranted.

Justification for selection of respiratory sensitisation endpoint:
No study available. The endpoint conclusion is not based on a study, but on human experience.

Justification for classification or non-classification

Skin sensitisation

Based on the available studies, XDI should be classified according to the CLP Regulation (EC) No. 1272/2008 with Cat.1A, H317 "May cause an allergic skin reaction".

Respiratory sensitisation

As XDI is a diisocyanate, XDI should be classified according to the CLP Regulation (EC) No. 1272/2008 and ECHA Guidance with Cat. 1, H317 "May cause allergy or asthma symptoms or breathing difficulties if inhaled".