Registration Dossier

Administrative data

Description of key information

A GLP-study according to OECD guideline 401 and several non-GLP studies equivalent or similar to OECD guidelines 401, 402 and 403 are available for ethyl 3-ethoxypropionate.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
4 309 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 967 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
4 080 mg/kg bw

Additional information

Oral: several studies on acute oral toxicity in rats are available for ethyl 3 -ethoxypropionate (EEP). All studies are off acceptable quality (Klimisch rating 1 or 2) and the reported LD50 values are all greater than 3200 mg/kg bw. The lowest LD50 of 4309 reported in the key study for female rats is taken forward for the risk assessment.

Dermal: several studies on acute dermal toxicity in rabbits and guinea pigs are available for ethyl 3 -ethoxypropionate. All studies are of acceptable quality (Klimisch 2) and the lowest reported LD50 was 4080 mg/kg bw in male rabbits. In guinea pigs no deaths were observed up to the highest dose tested (20 ml/kg bw).

Inhalation: several studies on acute inhalation toxicity in rats are available for ethyl 3 -ethoxypropionate. All studies are acceptable with restrictions (Klimisch 2). No mortality was observed in any of the studies at substantially saturated vapor concentrations. The highest concentration (998 ppm, 5967 mg/m3) that has been verified with analytics is taken forward for the risk assessment.

Justification for classification or non-classification

LD50 values for oral and dermal route are greater than 2000 mg/kg/bw and no mortality was observed in any of the acute inhalation studies at substantially saturated vapor concentrations. According to the EU criteria for classification and labeling, ethyl 3 -ethoxypropionate is not classified for acute toxicity for any route of exposure.