Registration Dossier
Registration Dossier
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EC number: 944-390-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on read-across from ethylene diformate (acute oral LD50 in the rat: 1510 mg/kg bw) the acute oral LD50 of the reaction mass in the rat is estimated to be within the same range. Due to the classification of the reaction mass as corrosive, studies on acute dermal and inhalation toxicity are not required.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 510 mg/kg bw
- Quality of whole database:
- Database is reliable, justifying the assessment factor of 1 for quality of data base.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
The acute oral toxicity of ethylene diformate (Smyth HF, et al, 1941) was tested by single gavage application to rats. The LD50 determined after the 14 -day observation period was 1510 mg/kg bw (95% CL: 1280 -1780 mg/kg bw). Since ethylene diformate hydrolyses rapidly to 2-hydroxyethylformate and subsequently to ethane-1,2-diol and formic acid (see toxicokinetics section) a comparable LD50 can be estimated for the reaction mass.
Acute dermal and inhalation toxicity
Due to the classification of the reaction mass as corrosive, studies on acute dermal and inhalation toxicity have not been performed.
Justification for classification or non-classification
The LD50 of the reaction mass is considered to be 300 mg/kg bw < LD50 < 2000 mg/kg bw. As a result the substance requires classification for acute oral toxicity, Cat. 4 (H302: Harmful if swallowed) under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918. Due to its corrosive properties a classification for acute dermal and inhalation toxicity is not warranted.
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