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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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).

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