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: see 'Remark'
Remarks:
Well-conducted study, available as unpublished report, minor restrictions in design and reporting, but otherwise adequate for assessment. Proof of the identity of the substance used in a study is the responsibility of the data owner of the study (internal company reference code 15537).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
The test substance was administered at dose level 2000 mg/kg bw to the clipped skin of 10 rabbits (5 non-abraded, 5 abraded) for 24 hr under occlusive conditions. At 24 hours, patches were removed and the site washed. Animals were observed for 14 days for signs of mortality, toxicity and pharmacological effects. Gross pathology was performed on animals which died during the study
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CPRD #10233, Safety Study #212-82
- Physical state: pale yellow liquid
- Specific gravity: 1.05
- Supplier: American Cyanamid Company
- Date of receipt: 5/03/82
- Storage: in the container provided by the sponsor at ambient room temperature and humidity

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 2.1-2.7 kg
- Housing: 2/cage in suspended wire mesh cages
- Diet: fresh Purina Rabbit Chow (Diet #53-21), ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: ca. 10% of the body surface
- % coverage: 100
- Type of wrap if used: gauze patch; the torso was further wrapped with plastic which was secured with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hr

Duration of exposure:
24 hr
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded pretest and at termination in the survivors.
- Necropsy of survivors performed: no
- Other examinations performed: the test sites were scored for dermal irritation on days 1, 7 and 14 using the numerical Draize scale.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no mortalities.
Clinical signs:
Lethargy, diarrhea, few feces and/or ptosis were noted in isolated instanses.
Body weight:
Body weight changes were normal
Other findings:
Dermal responses, generally slight on day 1, were minimal on day 7 and absent on day 14.

Applicant's summary and conclusion