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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:
1999-12-09 to 1999-12-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butyloctanoic acid
EC Number:
248-570-1
EC Name:
2-butyloctanoic acid
Cas Number:
27610-92-0
Molecular formula:
C12H24O2
IUPAC Name:
2-butyloctanoic acid
Test material form:
liquid
Details on test material:
- Name of test material: 2-butyl octanoic acid
- Molecular formula: C12H24O2
- Molecular weight: 200.32 g/mole
- Smiles notation: O=C(O)C(CCCCCC)CCCC

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS:
- Source: Harlan Nossan S. r. l., Correzzana (MI), Italy
- Age: approx. 5-6 weeks
- Weight at study initiation: 126-150 g
- Controls: none

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution containing 0.5% (w/v) carboxymethylcellulose
Details on oral exposure:
ADMINISTRATION:
- Doses: single doses of 2000 mg/kg bw
- Volume administered: 10 ml/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Post dose observation period: 14 days
EXAMINATIONS: Observation for clinical signs immediately upon dosing, approx. 1, 2, 4 hours after dosing and daily thereafter. Mortality and morbidity check twice daily. Individual body weights were recorded just prior dosing and 7 and 14 days after.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the 14 day post-dose observation period.
Clinical signs:
Piloerection, hunched posture, salivation, reduced activity, swollen abdomen, difficulty in moving, hairloss on head and red staining on muzzle.
Recovery of clinical signs had occurred by day 2 in females and by day 13 in males
Body weight:
Changes in body weight observed during the period of the study were within the range expected for this strain and age of animal.
Gross pathology:
No abnormalities were found on necropsy of animals performed on tennination of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.
Executive summary:

The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.