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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study based on national standard, acceptable for assessment, but with limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Code of Federal Regulation - 16 CFR, Part 1500.3
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MIPB, isopropyl biphenyl
- Substance type: organic
- Physical state: liquid
- Lot-No. A-36477

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bunnyville Farms, littletown, Pennsylvania
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 3.1 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: one square inch (6.25 cm²); 2/4 animals per group, abraded or nonabraded skin
- Type of wrap if used: gauze patch wrapped with nonadsorbant binder.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with tap water

Duration of exposure:
24 h
Doses:
4640 and 6000 mg/kg bw
No. of animals per sex per dose:
4 per dose, in total 8 animals
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality, except
1/4 animals (group 4640 mg/kg) on day 2, but considered unrelated to the treatnment and was replaced.
Clinical signs:
Depression in all animals but 1/4 in the 6000-mg/kg group,
anorexia in 3/4 and phonation in 1/4 animals in the 4640-mg/kg group.

Body weight:
no data
Gross pathology:
1/4 animals jelly-like material in the intestines,
no other particular findings in any of the other animals.
Other findings:
Signs of dermal irritation observed in all of the rabbits at the 4640 mg/kg level included slight to moderate erythema and slight desquamation.
At the 6000 mg/kg level, slight to moderate erythema and slight desquamation occurred in all of the animals with the findings being of longer duration in the abraded site animals. Edema occurred on Day 1 in one intact site animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU