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Toxicological information

Acute Toxicity: dermal

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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
A single dermal dose of the undiluted test substance was applied to one group of 10 Wistar rats (5 males and 5 females) at a dose level of 4000 mg/kg bw (3.43 mL/kg). The test material was applied to the clipped epidermis (dorsal and dorsolateral parts of the trunk) of each animal and was covered by a semiocclusive dressing for 24 hours. Post-observation period: 14 days.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refridgerated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: 200-300 g
- Fasting period before study: > 15 h
- Housing: Single housing in fully air-conditioned rooms.
- Diet (ad libitum): Kliba-Labordiaet 343 (Klingentakmuehle AG, Kaiseraugst, Switzerland)
- Water (ad libitum): tap water
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: about 50 cm²
- Type of wrap: The bandage consisted of four layers absorbent Gauze and fixomull stretch (adhesive fleece).


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.43 mL/kg
- Concentration: undiluted


Duration of exposure:
24 h
Doses:
4000 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: Individual readings 30 - 60 min. after removal of the semiocclusive dressing (day 1), at least once each workday.
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight, scoring of skin findings.
Statistics:
Statistical analysis: Binomial test (Snedecor and Cochran, 1989).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Mortality:
No mortality observed.
Clinical signs:
Systemic signs of toxicity were not noted.
Body weight:
Body weight gain was generally observed in the course of the study.
Gross pathology:
No pathologic findings noted. No abnormalities were noted at necropsy of animals sacrified at the end of the study.
Other findings:
The following local effects were observed 1 day or 7 days after application: very slight, well-defined or moderate erythema, very slight to slight edema, scaling and superficial scabbing.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met