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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:
supporting study
Study period:
01.10.1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
- Principle of test: Patch test to determine skin irritaion and corrosion in rabbits
- Short description of test conditions: The flank skin of 2 rabbits was depilated with an electric machine on an area of a minimum area of 6 x 3 cm. One half of the shaved skin area was additionally skarified with a cupping peeler. 0.5 ml of the undiluted test substance were applied on approx. 2.5 x 2.5 cm gas compress. The ccompress were fixed on the prepared skin with adhesive stripes and cover with impermeable PVC- foil (6-8 cm). Finally, the hull of the animals were wrapped with an elastic (Dauerbinde K). The exposure time was of 1 hour. The evaluation of the irritant effect was done right after the removal of the patches.
- Parameters analysed / observed: Irritation of the skin
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Specific details on test material used for the study:
undiluted test substance

Test animals

Species:
rabbit
Strain:
Himalayan
Remarks:
Albino Himalayan rabbits Hoe: HIMK (SPF Wiga) own breeding
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Weight at study initiation: 1.5 to 2.0 kg
- Housing: one animal per cage
- Diet (e.g. ad libitum): ERKA 8300 ab libitum
- Water (e.g. ad libitum): ab libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: flank skin
- % coverage: minium area of 6 x 3 cm
- Type of wrap if used: impermeable PVC foil (6-8 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: 1 hour

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL with gas compress of 2.5 x 2.5 cm
- Concentration (if solution): undiluted solution
- Constant volume or concentration used: yes
Duration of exposure:
1 hour
Doses:
0.5 mL of undiluted substance
No. of animals per sex per dose:
2 animals were tested
Control animals:
no
Details on study design:
- Necropsy of survivors performed: no
- Other examinations performed: animal behaviour

Results and discussion

Clinical signs:
After application of the undiluted substance, severe dark red erythema with deep skin damage was observed after 1 hour of exposure. A swelling of the skin was not observed. The treatment site had superficial cracks and a clear, colorless secretion. In a narrow area the skin was burned, green-brown and brown-black colored on the bulging edges. The two experimental animals reacted very violently when they were in contact with the test substance (screaming, stomping) and showed a very restless behavior after the consultation for about 20 minutes. Subsequently, the rabbits showed a dull passive behavior. For reasons of animal welfare law, the experiment was terminated after the aforementioned test.







Applicant's summary and conclusion

Conclusions:
The test of skin comptability of the test substance has shown that under the test conditions of the patch test, the undiluted test substance has strong skin-irritating properties and marked irritation. The results present in this study cannot be used for classification.
Executive summary:

The test of skin comptability of the test substance has shown that under the test conditions of the patch test, the undiluted test substance has strong skin-irritating properties and marked irritation.