Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Exposure based adaptation of information requirements:

According to REGULATION (EC) No 1907/2006, Annex IX and Annex X, repeated dose toxicity testing (section 8.6) may be omitted, if relevant human exposure can be excluded in accordance with Annex XI section 3. Furthermore and in accordance with section 3.2 (b) of Annex XI (as amended by Regulation 134/2009), testing for repeated dose toxicity can be omitted when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.

Classification:

Ethyl vinyl ether (EVE) is classified with H336 ("May cause drowsiness or dizziness") based on human data (abandoned historical use of EVE as human anesthetic agent).

At room temperature, EVE is a volatile and highly flammable liquid and may generate explosive atmospheres. The acute toxicity after inhalation is low. The available in vitro tests for genetic toxicity gave no hint on a mutagenic or clastogenic effect.

Process description:

The industrial method used for the production of EVE is the reaction of acetylene with ethanol in the presence of potassium hydroxide in the liquid phase (Reppe vinylation). The choice of operating pressure depends on the boiling point of the alcohol to be vinylated. The alcohol ethanol is vinylated under a pressure of ~1.5 MPa as the boiling point is below the reaction temperature. Working under pressure affords the acetylene to be diluted with nitrogen to avoid uncontrolled decomposition (75 % maximum for EVE). Because of the applied reaction conditions and the handling of gaseous compounds the manufacturing facilities are designed as closed systems for higher pressures. The reaction is carried out in a stirred vessel type reactor. The alcohol/KOH-mixture is charged at the top, while the gaseous mixture of acetylene and nitrogen is fed in from below. The un-reacted acetylene is recycled to the reactor and supplemented with pure acetylene. EVE is produced in a continuously run process in a closed system.Transfers, buffer/storage tanks, reactors, processing equipment and feeds are operated in fully closed systems. EVE is the starting material for the manufacture of polymers and co-polymers. During manufacture and processing of EVE, worker exposure is controlled by the use of closed systems, industrial hygiene controls, and personal protective equipment. Any risk of accumulation is minimized by natural ventilation, as the chemical is produced in closed systems installed in open air. At processing sites, the exposure of workers is minimized by vapor abstraction. Prior to repair and maintenance work, vessels, pipes and other equipment are purged to remove any residual EVE. Dedicated systems designed to handle EVE are used for loading and unloading purposes to prevent the formation of explosive atmospheres and to minimize exposure. The vent gases are either incinerated or cleaned by means of a scrubber. At the production and processing sites, workers wear personal protective equipment which includes gloves, face shields and safety goggles in view of the low pH during processing. During repair and maintenance operations, respiratory protective equipment is additionally used. Exposure to EVE via air is routinely controlled by personal air sampling. Additionally, only a small, well-defined and trained group of workers will perform occasionally sampling tasks for quality control under strictly controlled conditions.

Consumer exposure to residual EVE is considered to be negligible, since most of the marketed vinyl ether polymers and co-polymers are heat-treated and potentially existing residual EVE is expected to evaporate during this process.

 

Rigorous containment measures:

The substance is manufactured and used under strictly controlled conditions over the entire lifecycle. Exposure is limited to occasional sampling tasks for quality control. Transport, storage tanks, reactors, processing equipment, and feeds operate in fully closed systems.

 

Procedural and control technologies are used to minimise residual emissions/exposure as well as qualitative risk considerations:

Operational and technical conditions and measures affecting and controlling workers exposure, such as local exhaust ventilation as well as personal protective equipment, such as goggles, chemically resistant gloves, and respiratory protection where potential exposure may occur.

 

On the basis of the described process conditions, testing of EVE in a Sub-chronic Toxicity Study (OECD 413) as well as in a Chronic Toxicity Study (OECD 452) was not performed since the criteria of exposure based adaptation of information requirements are met.

Justification for classification or non-classification

Classification for repeated dose toxicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.