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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:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TP-90B Rubber Chemical
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone, Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 201-257 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Area covered: 10% of the total body surface of each animal.

Occlusion: A strip of aluminum foil was placed over the treated site, and the whole assembly held in place by encircling the trunk of the animal with a length of elastic bandage.

Removal of test substance: After a period of 24 hours, the adhesive bandage and gauze dressings were removed. The treated skin was washed gently with warm water to remove residual test item.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not required
Details on study design:
Animals were checked twice daily for mortality and morbidity. Clinical signs were observed immediately upon dosing, approximately 1, 2 and 4 hours after dosing and daily thereafter for a total of 14 days. Body weights were measured on Day -1, immediately prior to dosing (Day 1) and at weekly intervals thereafter (Days 8 and 15). All animals were killed on Day 15 by carbon dioxide narcosis. They were subjected to a gross necropsy examination for both external and internal abnormalities. The cranial, thoracic and abdominal cavities were opened to allow examination of their contents. Larger organs were sectioned. Particular attention was paid to the treated site.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred following dosing in male or female animals.
Clinical signs:
No signs of toxicity were observed.
Body weight:
Changes in body weight observed during the period of the study were within the range expected for this strain and age of animal in the males. The only exception was a single male, which showed a body weight loss during the first week of the observation period. A reduced body weight gain was also observed in the females at the end of the study.
Gross pathology:
No abnormalities were found on necropsy of animals on termination of the study.

Applicant's summary and conclusion