Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the results of the skin and eye irritation studies, this material should not be classified as 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)
Additional information
A primary skin irritation test was conducted withalbino rabbits. Following exposure, dermal irritation was evaluated by the method of Draize. Under the conditions of this study, the test substance caused well-defined erythema and slight edema. Dermal desquamation occurred for two animals on Day 10 (study termination). The inflammation was not perceived as significant as the mean values for erythema and edema were not equal to 2 (or more) by the 24 hour time point, or for at least two animals separately. Per Annex VI of the Dangerous Substances Directive, this material should not be classified as irritating.
A primary eye irritation test was conducted withalbino rabbits. Ocular irritation was evaluated by the method of Draize. There was no corneal opacity observed in any treated eye during this study. Under the conditions of this study, the test substance caused iritis, which cleared by 24 hours and conjunctival irritation, which cleared by 72 hours. All animals were free of ocular irritation by 72 hours. The test substance Methyl (Polyhydroxymethyl) Stearate can be considered as non-irritating to the eye (EU DSD, Annex VI).
Justification for classification or non-classification
Per Annex VI of the Dangerous Substances Directive, this material should not be classified as irritating.
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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