Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

The criteria for classification were not met.

Additional information

The dermal carcinogenic potential of isooctyl acrylate was assessed by applying a 25 microliters of a 5% (v/v) dilution in acetone to the backs of 40 C3H/HeJ male mice. These mice were selected because of a low incidence of spontaneous skin tumors. A negative control group receiving acetone was dosed simultaneously. The dermal route of exposure was selected because this constitutes the most likely route of exposure to this substance.

A squamous cell carcinoma, not at the site of application, was found in the treated group of mice. In addition, an initially diagnosed dermal melanoma was found at the site of application in the treated group. Two nodules in the acetone control group were diagnosed with a hematoma and fat necrosis. Skin alterations in the treatment group included hyperkeratosis, dermatitis and surface crusting.

The initially diagnosed melanoma was reviewed by an additional pathologist who stated 'that the cells comprising this melanoma are well differentiated with no indication of nuclear or cytologic pleamorphism or atypia. The lesion is well circumscribed and confined to the dermis.' It was the pathologist’s opinion was that this constitutes a benign lesion and would not be expected to invade or metastasize given non subsantive change in morphology if the animal had lived longer. (see attached letter -->ATT 1)

The conclusion reached is that the test substance was not found to be carcinogenic.