2-ethylbutyric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

other: Not available

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylbutyric acid

EC Number:

201-796-4

EC Name:

2-ethylbutyric acid

Cas Number:

88-09-5

Molecular formula:

C6H12O2

IUPAC Name:

2-ethylbutyric acid

Test material form:

not specified

Test animals

Species:

rat

Strain:

other: T23-48:Crj:CD(SD)IGS

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

0 (control) and 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 10 - 15 days.
- Frequency of observations and weighing: Hours after administration: 0-1, 2, 3, 4, 5, and 6; Days of observation: 2, 3, 4, 5, 6, 7, 8, 9, and 10-15.
- Necropsy of survivors performed: Yes.
- Other examinations performed: Body weight change measured on days 1, 2, 4, 8, 11, and 15.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

Transient salivation was evident within 1 hour after the treatment in one male and two females. One male and three females exhibited rales, which continued for several days, and there was a reported decrease in faeces volume and a perianal smudge noted in three males on day 2.

Body weight:

Reduction in body weight in both sexes

Gross pathology:

No abnormalities

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral LD50 (lethal dose, 50 %) of >2000 mg/kg was determined for 2-ethylbutyric acid in male and female rats.

Executive summary:

A 14-day experiment was undertaken to determine the acute oral toxicity of 2-ethylbutyric acid according to Good Laboratory Practise (GLP) and OECD Guideline 401 (Acute Oral Toxicity). Male and female rats (strain: T23-48:Crj:CD(SD)IGS) were exposed to 0 (control) and 2000 mg/kg in a corn oil vehicle as part of a limit test. Transient salivation was observed in one male and two females at 1-hour and one male and three females exhibited rales, which continued for a number of days. On day 2, three males were observed to have a perianal smudge and decreased faecal volume. Additionally, body weight in exposed rats was significantly lower than the 0 mg/kg control at some observation points. No mortality had been recorded at the termination of the experiment on day 14, nor abnormalities following necropsy that could be associated with the treatment. The acute oral LD50 for 2-ethylbutyric acid was subsequently determined to be 2000 mg/kg, which is outside of the criteria for classification as an acute toxin (oral) (CLP Regulation (EC) No 1272/2008).