Proposal to classify chloroethane as a reproductive toxicant and endocrine disruptor
A substance already classified for certain hazards
Chloroethane, which was formerly used as an anaesthetic, is a gas used as a fuel additive. It is also used in the manufacture of chemicals and rubber products. Between 100 and 1000 tonnes of chloroethane are manufactured or imported each year in the European Union.
Chloroethane has already been classified for the following hazards under the CLP Regulation:
- Flammable gas, Category 1 (H220: Extremely flammable gas),
- Gases under pressure,
- Carcinogenicity, Category 2 (H351: Suspected of causing cancer),
- Hazardous to the aquatic environment, chronic toxicity, Category 3 (H412: Harmful to aquatic life with long-lasting effects).
New adverse effects identified
Available studies on animal models have shown that chloroethane has adverse effects in rats on sperm count and quality across two generations, and leads to pre-implantation losses (embryos lost before implantation in the uterine lining) and a longer gestation duration.
Moreover, post-implantation losses (embryos lost after implantation in the uterine lining) were observed in female rats during gestation. In male pups exposed in utero until weaning, delayed sexual maturation and a reduction in anogenital distance were observed. Furthermore, in rabbits, skeletal malformations were observed in foetuses exposed in utero.
The effects observed in adult male rats and during development show that the substance is an endocrine disruptor for human health. As these effects can impact species found in the environment, the endocrine-disrupting nature can therefore also be considered relevant for the environment.
In light of the findings of these studies, ANSES recommends extending the harmonised classification of chloroethane under the CLP Regulation to include the following hazard classes:
- Reproductive toxicity, Category 1B (H360FD: May damage fertility. May damage the unborn child);
- Endocrine disruption for human health, Category 1 (EUH380: May cause endocrine disruption in humans);
- Endocrine disruption for the environment, Category 1 (EUH430: May cause endocrine disruption in the environment).
Harmonised classification proposal submitted for public consultation
The harmonised classification for chloroethane proposed by ANSES has been made available for public consultation on the ECHA website until 26 June 2026. This consultation gives all stakeholders the opportunity to comment on these proposals, while providing any additional scientific arguments and further information they may have.
Following this consultation stage, ANSES will be asked to respond to the comments received. The initial proposal, comments and ANSES's responses to them will then be placed before ECHA’s Committee for Risk Assessment (RAC), which will debate them and issue an opinion on the classification of chloroethane.
Based on this opinion, the European Commission will draft regulatory texts allowing the proposed classifications to be included in the CLP Regulation.
The Regulation on Classification, Labelling and Packaging (CLP)
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, known as the CLP Regulation, is the legislation in force in the European Union to ensure the protection of workers, consumers and the environment with regard to chemicals. In particular, it aims to identify any hazards posed by a substance or substance mixture due to its physico-chemical properties and/or its effects on health and the environment. This Regulation defines how these substances and mixtures must be classified, labelled and packaged. It also has impacts on other European regulations, possibly leading to the prohibition or substitution of substances or mixtures depending on their hazard characteristics. Once a substance or mixture has been classified with regard to the identified hazards, appropriate labelling informs the user about these hazards through pictograms and safety data sheets. ECHA is responsible for implementing the CLP Regulation.