Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-24 to 1985-06-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10-12 weeks
- Weight at study initiation: male: 324-353 g, female: 275-286 g
- Housing: individually for 24 h after exposure; up to 5 animals per dose per sex in polypropylene cages
- Diet: ad libitum, no food over night before treatment and 2 h after treatment, Rat & Mouse Expanded Diet No. 1, supplied by Special Diet Services Limited, Witham, Essex
- Water: ad libitum, tap water
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 ± 2.5
- Humidity (%): 45-66
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: hair clipped dorsal, lateral and ventral regions (6 x 12 cm)
- % coverage: 10 % of complete body surface
- Type of wrap if used: 7 x 4 cm patch of surgical gauze, strip of elastic adhesive bandage wrapped around the trunk of the animal twice

REMOVAL OF TEST SUBSTANCE
- Washing: skin and surrounding hair were sponged thoroughly with warm water, rinsed and dried using absorbant paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 50 mg/kg bw (0.05 mL/kg), 400 mg/kg bw (0.43 mL/kg), 2000 mg/kg bw (2.13 mL/kg), 5000 mg/kg bw (5.32 mL/kg)
- Concentration: undiluted
- Constant volume or concentration used: yes, several animals were treated with constant concentrations and for within each concentration group a constant volume was used
Duration of exposure:
24 h
Doses:
50, 400, 2000 and 5000 mg/kg bw
No. of animals per sex per dose:
2 for range finding test, 5 for main study
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2, 3, 4 and 5 h after application and afterwards at least once per day. The body weight was measured on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
Animals showed no observable response to treatment.
Body weight:
One female showed a small weight loss in the first week and reduced weight gain in the second week. Other animals showed normal weight gain.
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal toxicity study in rats was performed. The animals showed no signs of toxicity and therefore it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.
Executive summary:

An acute dermal toxicity study in rats was performed according to OECD 402 with 50, 400, 2000 and 5000 mg/kg bw of the test substance. One female rat showed a small weight loss in the first week and reduced weight gain in the second week, while all other animals showed a normal weight gain. No mortality was observed and the animals showed no signs of toxicity. Due to these results it was concluded that the dermal LD50 was > 5000 mg/kg bw in rats.