International. Recently, 2-ethylhexanoic acid (2-EHA) has shown no adverse effects with respect to reproduction at the highest dose tested in a study conducted at the request of the European Chemicals Agency (ECHA).
Due to previous suspicions about reproductive toxicity, ECHA included 2-EHA in the Community Balancing Action Plan (CoRAP) as CMR (reproductive toxicity - fertility) and potential neurodevelopmental toxicity. This list has now been removed: 2-EHA is no longer considered for further classification and labeling. The product is considered safe with risk mitigation measures in place.
The reason for this inclusion was the presumed toxicity in fertility, as well as the wide dispersive use, the possible use of the consumer and the high level of added tonnage. These concerns were based on the results of non-guided, non-GLP studies. In order to assess the potential hazard of 2-ethylhexanoic acid, an additional reproductive toxicity study was conducted in rats. The result of this study did not indicate any adverse effects with respect to reproduction at the highest dose tested.
On the basis of the available information, the evaluating Member State, Spain, supported the conclusion. Spain also concluded in its report that no additional classification is required and that no further risk management measures based on the exposure scenarios assessed in the dossier are needed. 2-EHA will continue to be classified as reproductive toxicity category 2, which means that consumer use should be restricted and some risk mitigation measures should be taken into account when used in production facilities.
The Product Manager for Perstorp (one of the world's largest producers of 2-EHA), Andreas Nilsson, states: "Even though 2-EHA is the most accessible and cost-effective carboxylic acid available, suspicion caused market sentiment to tilt towards 2-EHA replacement in some cases. These studies now make 2-EHA the best-researched carboxylic acid. We are very happy that these suspicions have been raised."
2-EHA (2-ethylhexanoic acid) is widely used in esters for PVB film plasticizers and synthetic lubricants, in the production of metal soaps for paint dryers, in automotive refrigerants and PVC stabilizers. Other areas of application include wood preservatives, catalyst for polyurethane and in pharmaceuticals. The annual production amounts to almost 300,000 tons.
Source: Perstop.
