Registration Dossier

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: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
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: Asta Pharma AG
- Age at study initiation: males 11 months; females 10-11 months
- Weight at study initiation: males 2.24-2.77 kg; females 2.41-2.84 kg
- Fasting period before study: 16 hrs. before treatment
- Housing: individualy in stainless steel cages with grating floor
- Diet: standard diet approx. 120 gram/day / animal
- Water: drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity: 35-65%
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: shorn skin between shoulder and sacral region

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: test substance was moistened with the vehicle (1ml/gram test substance)
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continuously observed for the first 4 to 6 hrs after application and then daily; mortality was checked twice daily; body weihgty were recorded at the beginning, 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
no effects
Gross pathology:
no alterations

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
under the conditions of the study no acute toxic effect occurred after dermal application of 2000 mg/kg bw test substance