Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: C-01650 (4-HAP)
purity: 99.97%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Approximately weight = 2.0 - 3.0 kg at time of dosing. Animal weights fell within 20% of the group mean.
Each animal was assigned an unique and individual number. This number was permanently indicated on the animal with an ear tag.
Animals were housed separately from any other species. They were individually housed in stainless steel, wire mesh bottom cages.
Room temperature: 63 - 73°F; relative humidity: 30 - 70%; day/night rhythm: 12 h dark, 12 h light.
Fresh certified feed and fresh potable water was provided ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approxiniately 24 hours prior to dermal administration, the hair was clipped from the dorsal area of the animals. Five male and five female rabbite were randomly selected by a computer randomization program. Animals were selected based on their body weight the day of dosing. Undiluted test article was administered demally to five male and five female rabbits at a dose of 2.0 g/kg. Individual doses were adjusted based on tbe animal's body weight on the day of dosing. Immediately after test article administration, the application site was moistened sufficiently with sterile water to ensure good contact with the skin and then occlusively wrapped for 24 hours.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 13 days for a total of 14 days of observation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the animals died during the study period.
Clinical signs:
All of the animals on the study exhibited one or more of the following observations: abnormal stools, ocular discharge, erythema, and edema at the test site. By day 13, none of the animals had any observable abnormalities.
Body weight:
All of the animals gained weight by the end of the study period.
Gross pathology:
All of the animals were necropsied on the day following the last observation. All of the animals exhibited no visible lesions at necropsy.

Applicant's summary and conclusion