Isobutylamine

Acute Toxicity: dermal

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:

other: 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 n

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.