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: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyryl chloride
EC Number:
205-498-5
EC Name:
Butyryl chloride
Cas Number:
141-75-3
Molecular formula:
C4H7ClO
IUPAC Name:
butanoyl chloride
Details on test material:
- Name of test material (as cited in study report): n-büttersäurechlorid
- Substance number: XXVI 622
- Substance type: liquid

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: males: 208 g; females: 176 g
- Diet: Herilan MRH

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 42 cm2
Duration of exposure:
24 hours
Doses:
1000 and 2000 mg/kg bw
No. of animals per sex per dose:
3 (1000 mg/kg bw)
6 (2000 mg/kg bw)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily (except the weekends)
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0/6 at 1000 mg/kg bw
1/12 at 2000 mg/kg bw
Clinical signs:
Dyspnea (at the start of the study), apathy, aggression, uncoordinated movement, spastic gait, anaemic appearance, poor general condition, local skin irritation converting to necrosis.
Body weight:
Normal body weight gain was observed.
Gross pathology:
Animals dying during the test: hart: acute atrial dilatation, local acute hyperaemia; liver: anaemia.
Animals sacrificed at the end of the observation period: no abnormalities.

Applicant's summary and conclusion

Categories Display