Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
BASF-Test: A test group consisting of 3 Sprague-Dawley rats /sex was treated with single dermal applications with unchanged test substance (1000 and 2000 mg/kg bw) or a 50% test substance solution in olive oil (400 mg/kg bw). Exposure took place on 50 cm2 of clipped skin for 24 hours under occlusive conditions. 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: Firma Wiga, Sulzfeld
- Weight at study initiation: males mean weight: 237 g; females mean weight: 186 g
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Remarks:
(only the 400 mg/kg bw application)
Details on dermal exposure:
TEST SITE
- Area of exposure: about 50 cm2
- Type of wrap if used: inert foil fixed with tape

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Drying: with cellulose
- Time after start of exposure: 24 hours

TEST MATERIAL
- Concentration: 2000 and 1000 mg/kg bw applications: unchanged; 400 mg/kg bw application: 50% in olive oil
Duration of exposure:
24 hours
Doses:
400, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: observations on mortality reported after 1 hour, 1 day, 2 days, 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred at any of the doses applied.
Clinical signs:
Systemic effects:
Dyspnea, apathy, agitation, poor general condition.

Local effects:
At 400 mg/kg bw: After 24 hours: spotted necrosis and slight edema; After 7 days, slightly scaled skin and slight spotted parchment-like necrosis. After 13 days: partial slight spotted necrosis.
At 1000 mg/kg bw: After 24 hours: equivocal redness and slight edema; After 7 days: slight spotted necrosis with slightly scaled skin; After 13 days: partial slight spotted necrosis.
At 2000 mg/kg bw: After 24 hours: equivocal redness, partial strong spotted necrosis, strong edema; After 7 days, strong spotted parchment-like necrosis; After 13 days, strong spotted leather-like necrosis.
Body weight:
A normal body weight gain was observed.
Gross pathology:
No effects.

Applicant's summary and conclusion