Registration Dossier

Administrative data

Description of key information

A 28-study in rats with oral gavage administration of the test material is available for ethyl 3-ethoxypropionate. This study was conducted under GLP and according to OECD guideline 407. For the inhalation route a 90-day in rats conducted under GLP and according to OECD guideline 413 and a non-GLP two-week inhalation study in rats equivalent to OECD guideline 412 are available. In addition a repeated exposure dermal irritation study (non-GLP, not following any guideline) in guinea pigs is available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
500 mg/m³

Additional information

Oral: In a 28-day study in rats with oral gavage administration of the test material no significant adverse effects were observed with ethyl 3-ethoxypropionate. At the highest dose level (1000 mg/kg bw/day) the aspartate aminotransferase and creatinine levels were slightly increased in both sexes, the sorbitol dehydrogenase levels were moderately increased in the males and slightly increased in the females, and the alanine aminotransferase levels were slightly increased in the females. The probable site of toxic action is the liver. The clinical chemistry determinations of the lower dose (100 mg/kg bw/day) males were comparable to the controls. The no observed adverse effect level (NOAEL) for Ethyl 3-Ethoxypropionate is 1000 mg/kg bw/day based on slight changes in liver enzymes. The no observed effect level (NOEL) is 100 mg/kg bw/day.

Inhalation: in a 90-day vapor inhalation study with rats the most notable systemic effect of EEP exposure was a decrease in body weight gain for males and females exposed to 1000 or 500 ppm. The cause of the decreased weight gain was not determined. There were no statistically significant clinical pathologic findings or organ weight changes that were indicative of a toxic response, or any histopathologic findings to suggest a pathologic effect. It is concluded that the principal systemic effect following exposure to 1000 and 500 ppm EEP is a statistically significant decreased body weight gain. Although EEP was not without toxicity the effects seen were of a non-specific nature and did not permit the identification of a target tissue. The no-observed effect level for systemic toxicity is 250 ppm EEP and the no-observed adverse effect level for systemic effects is 500 ppm. This data is supported by a two-week inhalation study in rats with no adverse systemic effects observed up to the limit dose of 1000 ppm.

In addition to those systemic effects slight local irritation was observed at 250 ppm. Therefore, this dose level is considered to be the LOAEC for local effects.

Dermal: repeated applications (9 over a 10 day period) to the clipped backs of guinea pigs produced slight exacerbation of the irritative response. No evidence of percutaneous absorption was seen.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification

The no observed adverse effect levels for ethyl 3 -ethoxypropionate exceed the values triggering classification via all routes of exposure. Therefore no classification for prolonged exposure is required.