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Category name:
PM_Hydroxyalkyl Methacrylates

Justifications and discussions

Category definition:
chemical category name: Hydroxyalkyl Methacrylates
Category description:
Currently included in the assessment are hydroxyethyl and hydroxypropyl methacrylate plus the metabolites methacrylic acid, methyl methacrylate, ethylene glycol and propylene glycol as supporting chemicals
Category rationale:
Where data are not available on the target substance, read across has been used to fill endpoint gaps. For human health endpoints, the data gaps refer basically to higher tier endpoints on systemic toxicity. The assessment for the hydroxyalkyl methacrylates as category adopts in the read across approach described in Scenario 4 of ECHA’s RAAF guidance (2017). This scenario covers the category approach for which the read-across hypothesis is based on different compounds which have the same type of effect(s), namely the rapid hydrolysis. One a single substance level, the assessment for HEMA and HPMA, respectively adopts the read across approach described in Scenario 1 of ECHA’s RAAF guidance. This scenario covers the analogues approach for which the read-across hypothesis is based on (bio)transformation to common compound(s), namely to methacrylic acid (MAA) and the respective alcohol. For these REACH information requirements, the effects obtained in a study conducted with one source substance are used to predict the effects that would be observed in a study with the target substance if it were to be conducted. The same type of effect(s) or absence of effect is predicted. The predicted strength of the effects may be similar or based on a worst case.

See attached Category Justification for further details.