Studies by Spain on 2-ethylhexanoic acid - a carboxylic acid used in esters for synthetic lubricants - found no adverse effects concerning reproduction at the highest dose tested, which means the chemical is no longer under consideration for additional classification by the European Chemicals Agency.
Sweden-based Perstorp, which claims to be the worlds largest producer of 2-EHA, issued a press release on April 5 about the studys findings and the chemicals removal from the action plan list. Other notable producers of 2-EHA include BASF, Oxea, Eastman and KH Neochem.
According to Perstorp, the agency had listed the chemical on its annually updated Community Rolling Action Plan (CoRAP) based on determination that it was toxic to fertility and potentially toxic to neurodevelopment. Following member state Spains study findings, the chemicals agency removed 2-EHA from the action plan. 2-EHA is no longer under consideration for additional classification and labeling, Pertorp stated. This product is considered safe with risk mitigation measures in place.
Perstorp said that 2-EHA will remain classified as Reproductive Toxicity Category 2, which means restricting consumer use and taking risk mitigation measures when using it at production facilities.
Despite 2-EHA being the most accessible and cost-effective carboxyloic acid available, the suspicion caused the market sentiment to sway towards replacement of 2-EHA in some cases, Andreas Nilsson, product manager for Perstorp, said in the companys news release. These studies now make 2-EHA the best investigated carboxylic acid. We are very happy that these suspicions have been lifted.
The chemical was originally selected for substance evaluation to clarify suspected risks about reproductive toxicity - fertility, wide dispersive use, consumer use, high aggregated tonnage and high risk characterization ratio. According to Spains substance evaluation documentation, an additional reproductive toxicity study was performed on rats to assess the potential hazard of 2-ethylhexanoic acid. The evaluation noted that the original concerns were based on results of a one-generation reproductive toxicity study, which was neither carried out in according with any internationally recognized test method nor in compliance with good laboratory practice (GLP).
No fertility or reproductive effects were observed in male and female rats in the original combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, according to the substance evaluation conclusion document. This new information from good quality studies does not confirm any of the findings related to fertility and neurodevelopmental toxicity that were observed in the previous non-guideline and non-GLP studies.
In its substance evaluation documentation, Spain concluded the new studies provide sufficient and reliable information to conclude that 2-EHA does not show a specific effect on fertility and neurodevelopmental toxicity. For this reason, the evaluating [member state competent authority] considers that the concerns have been clarified, and neither further information nor additional classification is required following this substance evaluation, it stated.
According to Perstorps website, 2-EHA is a colorless liquid widely used in esters for synthetic lubricants and PVB film plasticizers, in production of metal soaps for paint driers, in automotive coolants and PVC stabilizers.