Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-407-9 | CAS number: 63948-88-9
Endpoint summary
Administrative data
Description of key information
The substance is not irritating to skin or eye.
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
For ZAN 573, in vitro testing was inconclusive for skin and eye irritation, necessitating the conduct of in vivo testing. The substance was found not to be irritating to the skin of rabbits. Eye irritation (mild) was observed which resolved within 7 days, primarily in one of three animals in vivo. The substance is not evaluated to be an eye irritant. No studies were undertaken for respiratory irritation.
The substance is a member of the category of cyclic acid anhydrides, which are known to cause respiratory irritation and sensitisation. ZAN 573 has similar chemical behaviour and analogous breakdown products in environmental and biological systems as the category members. The common functional group is a1,3-dioxo-1,3-dihydro-2-furan ring (i.e., a cyclic acid anhydride) directly attached to an aromatic ring. The cyclic anhydride moiety is quickly hydrolysed to form a dioic acid. The cyclic acid anhydride moiety and its dioic acid derivatives are the principal loci of toxicity, rather than the remainder of the molecule. Within the category, oligomeric forms of the cyclic acid anhydrides are less likely to be absorbed across biological membranes than the simple, monomeric forms, so that this read-across represents the worst case scenario.
Justification for classification or non-classification
The substance is demonstrated not to fulfil irritation criteria for skin or eye, in vivo. The criteria of Regulation (EC) No 11272/2008 are not met, and so the substance is not classified for these routes of administration. Without specific data on skin and eye irritation, the substance would have been classified for these endpoints also, consistent with other category members.
Due to its structural features, category membership and specific content of trimellitic anhydride, the substance is classified as a respiratory irritant, STOT-SE Category 3, H335.
The category-based read-across information to acceptable to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.
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.
