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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with the test substance dissolved in olive oil. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyryl chloride
EC Number:
201-194-1
EC Name:
Isobutyryl chloride
Cas Number:
79-30-1
Molecular formula:
C4H7ClO
IUPAC Name:
isobutyryl chloride
Details on test material:
- Name of test material (as cited in study report): Isobuttersäurechlorid
- Substance number: 79/625

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight at study initiation: male mean weight: 202 g; female mean weight: 172 g
- Fasting period before study: 15-20 hours before administration

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
Concentration in vehicle: 2.94 - 29.4 % (w/v)

MAXIMUM DOSE VOLUME APPLIED:
5 mL/kg
Doses:
147, 316, 464, 681, 1000, 1470 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: at the start of the test and after 2-4, 7 and 13 days
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 680 - < 1 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 100 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred at 147-681 mg/kg bw
5/5 males and 1/5 females died at 1000 mg/kg bw
10/10 animals died at 1470 mg/kg bw
All deaths were observed 1 hour - 1 day after administration of the test substance.
Clinical signs:
147 and 316 mg/kg bw: no clinical signs
464 mg/kg bw: dyspnea, apathy, uncoordinated movement, poor general state
681 mg/kg bw: dyspnea, apathy, uncoordinated movement, bristly fur, poor general state
1000 mg/kg bw: dyspnea, apathy, anomalous lying behaviour, atonia, uncoordinated movement, bristly fur, salivation, poor general state
1470 mg/kg bw: dyspnea, agonal respiration, apathy, anomalous lying behaviour, uncoordinated movement, trembling, convulsions, bristly fur, poor general state
Body weight:
No effects on body weight gain were noted.
Gross pathology:
Animals which died during the test: Hart: atrial dilatation, local acute hyperaemia; Stomach: extensive haemorrhagic ulceration with haematic contents (corrosive gastritis); Bowels: strong reddening of the mucosa with haemorrhagic contents.
Animals sacrificed at the end of the observation period: no abnormalities.

Applicant's summary and conclusion