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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 September 1978 - 16 November 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
two dose levels; scarce study report omitts details of test conditions which are, however, contained in raw data.
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 2.95 kg; females: 3.1 kg
- Diet: SNIFF, ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm² (200 mg/kg bw) and 45 - 102 cm² (400 mg/kg bw)

REMOVAL OF TEST SUBSTANCE
- Washing: After the application time the skin was washed with water/Lutrol (1:1)
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
200, 400 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 400 mg/kg bw
Mortality:
400 mg/kg bw: After day 7 4/5 males and 5/5 female rabbits died and mortality ocurred mainly within the first 24 hours.
200 mg/kg bw: None of the 5 male rabbits died and 3/5 females died within 24 hours.
Clinical signs:
Systemic toxicity: cyanosis, apathy, dyspnea, accelerated breathing, abdominal position with flaccid extremities, lateral position, trembling.
Local irritations: All animals showed formation of soft necrosis after removal of dressing. The surviving animals showed formation of a hard, non-displaceable necrosis within the observation period.
Body weight:
no data
Gross pathology:
Animals that died:
Heart: acutely dilated, right; acute congestion;
Lungs: notable congestion, in some animals edematized;
Liver: gray-white lobular periphery broader.

Any other information on results incl. tables

Table 1: Mortality

 Dose (mg/kg bw)  Gender  1 h  24 h  48 h  7 days 14 days 
 200  male  0/5  0/5  0/5 0/5  0/5
 200  female  0/5  3/5  3/5  3/5  3/5
 400  male  0/5  3/5  3/5  4/5  4/5
 400  female  0/5  5/5  5/5  5/5  5/5

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria