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EC number: 222-852-4
CAS number: 3634-83-1
There are 4 studies available that address skin sensitisation properties
of XDI. 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
Based on these results, XDI is considered to be a skin sensitiser
No signs of ill health or toxicity were noted. Bodyweight increases in
test group animals were comparable to control group animals. During
induction, slight irritation was seen in test and control animals after
intradermal injections, slight erythema was observed after topical
application in test and control animals.
Bodyweight gains in the test group and control group were comparable.
After challenge, both in test as well as the control group, very slight
to well defined erythema were noted at the challenge sites sometimes
together with very sligh oedema.
At 50%: After re-challenge very slight erythema was noted in one animal
of the control group. Positive oedema responses were noted at challenge
sites of all test group animals at the 24-h observation and five test
group animals at the 48-h observation (erythema could not be scored due
to adverse reactions). At 25%: no skin reactions were noted in the
control group. Positive skin responses were noted at the challenge site
of all animals at 24 hr observation and in 7/8 animals at 48 hr
Bodyweight gains in test group were comparable to control group animals.
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
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
Based on the available studies, XDI is
classified according to the CLP Regulation (EC) No. 1272/2008 with
Cat.1A, H317 "May cause an allergic skin reaction".
As XDI is a diisocyanate, XDI is 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".
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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