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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
reporting details
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyric anhydride
EC Number:
202-603-6
EC Name:
Isobutyric anhydride
Cas Number:
97-72-3
Molecular formula:
C8H14O3
IUPAC Name:
isobutyric anhydride
Details on test material:
- Physical state: liquid
no further data provided

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean: male: 318g; female: 223g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 - 31.6%

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
Doses:
10000, 6810, 4640, 3160 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: before substance application and on day 4 and day 7 after application. Observations: daily
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 7 700 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Mortalities were seen at all doses except for the low dose group
Mortality:
At the highest dose (10000mg/kg) all animals died within 48 hours. At 6810 mg/kg 3 of 5 female rats died within 24 hours and 1 male rat died after 7 days of application. At 4640 mg/kg 1 of 5 female rat died after 7 days. At the lowest dose no animal died within the observation time of 14 days.
Clinical signs:
In all dose groups in the first hours after treatment were dyspnae, apathy and staggering found. In the higher dose groups (except lowest dose group) abdominal position, tremor, opisthotonus, diarrhoe, exsiccose, lacrimation and salivation were found.
Body weight:
At the lowest dose animals showed normal body weight gain at all time points. In the other groups at the beginning of the study a body weight reduction was seen which normalised during the further study.
Gross pathology:
animals found dead: heart: acute dilatation and hyperemia; stomach: dilated, strong intravascular injection, substance induced mucosal malacia as well as bloody ulceration in the glandular stomach; intestine: partly atonic
scheduled sacrificed animals: stomach: agglutination of the gastro-oesophageal vestibule.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU

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