[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Diisobutylen nitrosate (approx. 20% pure) was applied to the clipped, intact skin of 1 male New Zealand White rabbit each at a dose of 1000, 2300 or 3400 mg/kg bw. Additionally 2 rabbits were dosed at 5000 mg/kg bw. the test sites were occluded for 24 hours. Observations for mortality were made daily for 14 days after treatment.

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

not available

EC Number:

691-232-7

Cas Number:

474266-68-7

Molecular formula:

not available

IUPAC Name:

not available

Details on test material:

composition:
app. 20% diisobutylene nitrosate
app. 80% diisobutylene

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

1000, 2300, 3400 or 5000 mg/kg bw

No. of animals per sex per dose:

1000, 2300 or 3400 mg/kg bw = 1 animal/dose
5000 mg/kg bw = 2 animals/dose

Control animals:

not required

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

other: ALD = approximate lethal dose

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

The 2 rabbits treated with 5000 mg/kg bw died within 6 hours following application of the test material; no other deaths occured. Slight to severe erythema and mild edema were observed in the treated rabbits. Other dermal effects observed in the rabbits included necrosis, fissuring and epidermal scaling of the skin. In addition, labored breathing, vocalization, stained fur, convulsions and a change in eye color from pink to black were observed in the treated rabbits.

Applicant's summary and conclusion

Executive summary:

Diisobutylen nitrosate (approx. 20% pure) was applied to the clipped, intact skin of 1 male New Zealand White rabbit each at a dose of 1000, 2300 or 3400 mg/kg bw. Additionally 2 rabbits were dosed at 5000 mg/kg bw. The test sites were occluded for 24 hours. Observations for mortality were made daily for 14 days after treatment.

The 2 rabbits treated with 5000 mg/kg bw died within 6 hours following application of the test material; no other deaths occured. Slight to severe erythema and mild edema were observed in the treated rabbits. Other dermal effects observed in the rabbits included necrosis, fissuring and epidermal scaling of the skin. In addition, labored breathing, vocalization, stained fur, convulsions and a change in eye color from pink to black were observed in the treated rabbits.

Under the conditions of this test, the ALD was 5000 mg/kg of body weight.