Registration Dossier
Registration Dossier
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EC number: 254-372-6 | CAS number: 39236-46-9
Endpoint summary
Administrative data
Description of key information
A human repeat insult patch test found no evidence of skin irritation or sensitisation, and a test using patients expected to carry antibodies to formalin found no reactions to challenge with the test substance. In two other human studies, no significant primary irritation was reported.
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 human repeat insult patch test found no evidence of skin irritation or sensitisation, and a test using patients expected to carry antibodies to formalin found no reactions to challenge with the test substance.
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 may be high.
A concentration cutoff value of ≥ 1% is recommended.
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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