AA and its esters have been tested for developmental toxicity in at least one species via oral administration or inhalation. Neither evidence of fetotoxicity nor birth defects were seen at dose levels which did not cause maternal toxicity.

Subchronic and chronic testing indicates no effects on reproductive organs. Acrylic acid has been tested in a guideline two-generation reproduction study. The NOAEL for reproductive effects was an order of magnitude higher than that for parental toxicity in the F1 generation. There was no indication of an adverse reproductive effect at any dose level tested. A guideline two- generation reproduction study has also been conducted for methyl acrylate as representative for the other esters. In this study, the no-observed-effect concentration (NOEC) for parental systemic toxicity was based on microscopic changes in the nasal tissues seen at higher concentrations. Secondary to this parental toxicity, pup body weights were decreased, but no further developmental effects were observed. The NOEC for reproductive toxicity was 75 ppm, the highest concentration tested.

Excerpt from ARTF Category Justification - For this endpoint, the common primary metabolic pathway of the category members (i.e. common functional groups and rapid metabolism by ester cleavage leading to the common metabolite AA) is considered as the most relevant aspect of the category approach. Qualitatively, this aspect can be categorised as scenario 3 “(Bio) transformation to common compound(s)”, whereas AA is the toxicologically relevant metabolite for local and systemic effects.

The variable part of the category approach is the length or configuration of the side chain of the parent ester and the alcohol metabolite and their impacts on physico-chemical properties and subsequent properties. Despite the variation, the available data support a lack of toxicity for reproduction for all the category members across the tested species. Overall, the read-across is applied with a high level of confidence.

For more information, see Category Justifcation Document for use under EU REACH.

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