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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 278-928-2 | CAS number: 78491-02-8
Endpoint summary
Administrative data
Description of key information
In a human repeat insult patch test using an aqueous 0.5% solution of test substance, 1/97 subjects showed an irritant reaction but no sensitisation reactions were seen.
Dermal contact sensitisation to the test substance has however been confirmed in small numbers of human subjects showing dermal symptoms sufficient to cause referral for patch testing.
Additional information
A reliable study in which 97 volunteers participated found only one subject reacting to in a manner indicative of a cumulative irritation response, and no evidence of skin sensitisation.
Analysis of certain American patch test data for patients referred for confirmation of suspected skin sensitisation reactions suggests that possibly up to 1-5% of reported dermal sensitisation reactions to cosmetic products may be related to the test substance.
An expert review issued by the Australian chemical regulatory authority has concluded that human data suggest weak skin sensitisation potential of the substance.
A detailed investigation of dry patch test reactions has concluded that 600 microg/sq.cm is a safe concentration of test substance for use in sensitivity screening. The reported data suggest that 200 microg/sq.cm is likely to elicit reaction in most already sensitised subjects, and among the small population of individuals known to be sensitised cross-sensitivity to formaldehyde appears high.
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.
