Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2007
Bibliographic source:
IUCLID4 data set, 2007

Materials and methods

Test guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
a total of 10 animals
Details on study design:
TEST ORGANISMS:
- Strain: Hsd/Win:WU / SPF
- Source: Harlan Winkelmann GmbH, Borchen (Germany)
- Weight at study initiation: 200-300 g
- Controls: no
ADMINISTRATION:
- Area covered: dorsolumbar region, 50 x 50 mm2 = approximately 10 % of
the body surface
- Concentration in vehicle: 40 g/100 ml (suspension)
- Total volume applied: 5 ml/kg bw
- Occlusion: semiocclusive gauze dressing
- Removal of test substance: after 24 hours with warm water and absorbent
paper
EXAMINATIONS:
- Mortality: twice daily
- Clinical signs: 30 minutes after dosing, hourly thereafter for about 6 hours,
once daily for next 14 days
- Dermal response: once a day for 14 days
- Body weights: days 0 (prior to dosing), 7, and 14
- Macroscopic examination: day 14

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
MORTALITY: There were no deaths.
Clinical signs:
CLINICAL SIGNS: There were no signs of systemic reaction to treatment.
After removal of the dressing until the end of the study no skin irritations
were noticed. Body weight gain was satisfactory in males but low in
females, which is a physiological finding in rats at this age.
NECROPSY FINDINGS: No abnormalities were revealed by macroscopical
examination.

Applicant's summary and conclusion