Registration Dossier
Registration Dossier
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EC number: 406-370-3 | CAS number: 58890-25-8 MDI/CHA
Endpoint summary
Administrative data
Description of key information
Two in vivo skin irritation studies: not irritating
In vivo eye irritation study: not irritating
In vitro eye irritation study: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Six Japanese white rabbits were exposed to a single (occlusive) dose for 4 h. No irritation was observed. The result of the study was obtained from ELINCS notification 91-06-0295-00 (10-year rule). Information from migrated NONS file, as per inquiry number 06-2119971773-26-0000, permission to refer granted by ECHA.
In another skin irritation study, 3 albino New Zealand White rabbits were treated with the substance in accordance with OECD 404 (2002). A semi-occlusive application procedure was used. There was no mortality or systemic clinical changes related to the test item administration. There was no effect of treatment on body weight. At 1 hour after patch removal, well defined erythema (score 2) was observed in 1/3 animals. At 24 hours after patch removal, very slight erythema (score 1) was observed in 1/3 animals. At 48 and 72 hours after patch removal, there were no observed signs on the skin of the treated animals. Accordingly, the study was terminated after the observation performed at 72 hours. The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for erythema were 0.00, 0.33 and 0.00. The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for oedema were 0.00, 0.00 and 0.00.
Eye irritation:
In an in vivo eye irritation study with rabbits performed according to OECD 405 guideline and GLP principles, slight irritation (conjunctivae (redness) and chemosis) was observed in all animals. The effects were fully reversible within 7 days.
In a supporting study performed similar to OECD 437 (BCOP), an in vitro irritancy score of 2.4 was determined for the substance. As this score is <=3, it was also confirmed in an vitro study that the substance does not need to be classified for eye irritation.
Justification for classification or non-classification
Based on the study results, MDI/CHA does not have to be classified for skin irritation and eye irritation according to Regulation (EC) No 1272/2008 and its amendments.
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.
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