Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26.02. - 25.03.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted December 17, 1985
Deviations:
no
GLP compliance:
no
Remarks:
but performed under quality control, QAU statement included
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Appearance: yellow liquid
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAIf(SPF), F3-hybrid of RII 1/TIF x RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 209 to 252 g
- Housing: individually in Macrolon cages type 3 with standardized soft wood bedding
- Diet: Rat food, NAFAG No. 890, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before exposure

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 15 changes/hour
- Photoperiod: 12 hours dark/12 hours light

IN-LIFE DATES: from 26 February to 18 March 1986

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: area on the back of the rat
- % coverage: at least 10% of the body surface area
- Type of wrap: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: cleaned with lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw (males and females)
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, the animals were submitted to a gross necropsy at the end of the observation period.
- Other examinations performed:
Signs and symptoms: daily for 14 days
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Body weight: immediately before application and on days 7 and 14
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, sedation was observed on the application day. The animals recovered within 10 days.
Body weight:
All rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 in rats was determined to be greater than 2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study following OECD guideline 402, 5 male and 5 female rats were dermally exposed to the test item for 24 hours at a limit dose of 2000 mg/kg body weight. The test article was used undiluted and 2 ml/kg body weight was applied to the clipped back of the animals (10% body surface) under a gauze-lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed and residual test article was washed off with lukewarm water. All animals were observed once daily for 14 days for clinical signs and symptoms and twice daily for mortality. Body weights were recorded on days 1, 7 and 14. All animals were submitted to a gross necropsy at the end of the observation period. All animals survived the 2000 mg/kg dermal application. Dyspnea, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, sedation was observed on the application day. The animals recovered within 10 days. Body weight changes were normal and no deviations from normal morphology were found during necropsy. Based on these observations, the dermal LD50 value of the test item was greater than 2000 mg/kg bw.