Registration Dossier

Administrative data

Description of key information

A total of two key studies have been identified as having assessed acute toxicity in the rat following oral and inhalatory exposure. A supporting oral toxicity study using an analogue chemical (diethyl carbonate) as the test substance is also available and indicates minimal toxicologic effects. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
17 600 mg/m³

Additional information

Acute oral toxicity:

The key study followed the OECD 401 guideline and was GLP-compliant. Five male and five female rats were used for each dose group and observed for 14 days post-exposure. The main clinical findings were ataxia, hunched posture, lethargy, reduced respiratory rate and laboured respiration. The LD50 was determined to be >5000 mg/kg. A supporting study using a chemical analogue (diethyl carbonate) as the test material confirmed the findings of the key study of low oral toxicity and gave a LD50 of >15000 mg/kg.

Acute inhalation toxicity:

The key study followed the OECD 403 guideline and was GLP-compliant. A limit test using five male and five female rats was conducted with nose only exposure for 4 hours. Test animals were observed over a 14-day period and surviving animals were sacrificed and necropsied. Clinical effects during exposure include increase in respiratory rate, wet fur and an isolated instance of laboured respiration. No macroscopic abnormalities were observed at necropsy. The LC50 was determined to be >17.6 mg/l (measured).

Acute dermal toxicity:

This endpoint has been waived as the main route of exposure will be predominantly via the inhalation route.

Justification for classification or non-classification

Acute oral toxicity:

Based on the results of the key study (oral LD50 >5000 mg/kg) ethylmethylcarbonate is:

- Not classified for the oral route in accordance with the criteria given in Regulation 1272/2008 (EU CLP GHS).

- Not classified for the oral route in accordance with the criteria given in Directive 67/548/EEC (DSD).       

 

Acute inhalation toxicity:

Based on the results of the key study (inhalation LC50 > 17.6 mg/l) ethylmethylcarbonate is:

- Not classified for the inhalation route in accordance with the criteria given in Regulation 1272/2008 (EU CLP GHS).

- Not classified for the inhalation route in accordance with the criteria given in Directive 67/548/EEC.

Although there is a case for classification of the inhalation route, the findings of the key study indicate that no treatment-related mortalities were observed and in addition no significant clinical effects were observed (clinical effects that were observed were mainly due to restraint procedures - these were transient and disappeared by day 1).

Acute dermal toxicity:

No information available for classification.

No classification for acute toxicity via the oral, inhalation or dermal route is applied to ethylmethylcarbonate in Annex VI of the CLP Regulation No.1272/2008.