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: GLP guideline study according to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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 state: melt, yellow to dark yellow

- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, Switzerland
- Age at study initiation: Young adult animals
- Weight at study initiation: 220 - 246 g
- Housing: individually
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Switzerland); ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before exposure


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 45 - 65
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: distilled water
Details on dermal exposure:
TEST SITE
- Type of wrap if used: The test article was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml / kg bw (The test article was evenly dispersed on the skin.)
- Constant volume or concentration used: yes


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
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 application and on days 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occurred in this study.
Clinical signs:
Piloerection was seen, being a common symptom in acute dermal tests. At the application site, erythema was observed on day 1 after administration
to day 3 in the males, day 2 in the females. The animals recovered within 3 to 4 days.
Body weight:
- mean males: d0 - 230 g, d7 - 261 g, d14 - 301 g;
- mean females: d0 - 231 g, d7 - 233 g, d14 - 240 g;
Gross pathology:
At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under cconditions tested, the test substance did not show any death relating to dermal systemic effects. At the application site, erythema was observed on day 1 after administration to day 3 in the males, day 2 in the females. The animals recovered within 3 to 4 days.