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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White Russian
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: White Russian
- Age at study initiation: males 7-12 months, females 7-8 months
- Weight at study initiation: males: 2.48-2.67 kg, females 2.52 - 2.71 kg
- Fasting period before study: 16 h (overnight)
- Housing: individually, stainless steel cages with grating floor type ASTA, size: 48.5x40x36.5 xm supplied by ASTA Pharma AG
- Diet: Standard diet ssniff K; approx. 120 g/ day x animal
- Water: tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS: according to guideline

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: between shoulder and sacral region
- % coverage: not reported
- Type of wrap if used: occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/ kg bw, application was warmed up to 30 C to lower viscosity
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continuous observation for signs of toxicity the first 4 to 6 h p.a., then once daily; body weights were recorded at the beginning and also 7 d and 14 d p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Limit test

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured.
Clinical signs:
3 males showed piloerection on the first 3 days after application, no other symptoms.
Body weight:
2 females showed a slight decreased body weight
Gross pathology:
At necropsy no findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met