Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01.10. - 29.10.1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

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
Details on test material:
- Physical properties: liquid
- Storage conditions: room temperature

Test animals

Species:
rat
Strain:
other: Tif:RAIf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland
- Weight at study initiation: 217 to 248 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Macrolon cages type 3
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 01.10. to 17.10.1991

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: on the back of the animals
- % coverage: 10
- Type of wrap if used: a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned with lukewarm water.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount applied: 2 mL
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
Mortality : daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality occurred in this study.
Clinical signs:
Slight piloerection was observed in both, female and male animals. The animals recovered within 2 days.
Body weight:
The body weight was not affected.
Gross pathology:
At autopsy, no deviations from normal morphology were found.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The dermal LD50 value of the test article in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

The acute dermal toxicity of the test substance was assessed in a toxicity study following OECD guideline 402 and in compliance with GLP. The test article was administered to five TIF:RAIf rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortality occurred. Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days. At autopsy, no deviations from normal morphology were found. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.