Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No screening test for reproductive toxicity has been performed on ethyl methyl carbonate since 3-generation and developmental toxicity studies performed on a close chemical analogue are available.


Short description of key information:
A 3-generation rat study of the close chemical analogue diethyl carbonate found no effect of exposure (in drinking water, at a concentration calculated to deliver approximately 200 mg/kg/day) on fertility. The study design did not allow investigation of individual male fertility parameters and might therefore not have detected individual cases of such an adverse effect. However no indication of a group trend for impairment of male fertility was seen. Based on this and the absence of effect on male reproductive organs in rats dosed with ethyl methyl carbonate at 1000 mg/kg/day for 28 days (study reported in section 7.5 of this dossier), it is considered unlikely that ethyl methyl carbonate will show selective reprotoxicity and further testing for antifertility effects is not warranted.

Effects on developmental toxicity

Description of key information
In a mouse teratology study performed essentially in accordance with OECD guideline 414, high-level inhalational exposure (at 3000 ppm) to the close chemical analogue diethyl carbonate was associated with cases of skeletal abnormalities (fused vertebral arches, skullbone malformations) and variations (sternal and rib bones), as well as post-implantation losses and reduced foetal bodyweights.  However the close association with maternal toxicity (marked reduction of bodyweight gain: NOAELs the same for maternal and developmental toxicity) leads to a conclusion that dimethyl carbonate did not show selective developmental toxicity.  It is reasonable to assume that ethyl methyl carbonate would show closely similar activity in this type of study.

Justification for classification or non-classification

Based on the results of the reprotox studies, ethyl methyl carbonate is:

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

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

No classification for reproductive or developmental toxicity is applied to ethyl methyl carbonate in Annex VI of the CLP Regulation No. 1272/2008.