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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Propionsäure Hoe 31891
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Pharma Forschung Toxicologie
- Weight at study initiation: 153 - 200g
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum, ALTROMIN 1324 Atltogge Lage/Lippe
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm²
- Type of wrap if used: covered with aluminium foil and elastic patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 hours, rinsed with warm water
Duration of exposure:
24 h
Doses:
1000, 2500, 3150, 4000 and 5000 mg/kg
No. of animals per sex per dose:
6
Details on study design:
- Duration of observation period following administration: 14 - 21 days
- Other examinations performed: clinical signs, pathology
Statistics:
Linder & Weber; Cavalli-Sforza

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
3 235 mg/kg bw
Mortality:
1000 mg/kg: 0/6
2500 mg/kg: 1/6
3150 mg/kg: 1/6
4000 mg/kg: 6/6
5000 mg/kg: 6/6
Clinical signs:
Animals found dead died in a narcotic like condition in abdominal position. The skin on the back was dicoloured brown,hard and necrotic.
Gross pathology:
sacrificed animals: no abnormality
animals found dead: 5000 mg/kg: 3 dead animals showed pale spotted liver and a bloody small intestine. Regarding to autolytic changes, no macroscopic assessement of the other dead animals was possible.

Applicant's summary and conclusion