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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Comparable to guideline study, predates GLP, very limited reporting, but acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
Single dose of 2000 mg/kg bw of the test substance was applied to pre-moistened hair-clipped skin of each of the 6 rabbits under occlusive dressing. The patch was removed 24 hours post-dosing and animals were observed for 7 days.
GLP compliance:
no
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): Ethyl Ziram (WTR 38)
- Physical state: White powder

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- Type of wrap if used: Covered with a two-ply layer of wet gauze and overcovered with an empervious sleeve.
Duration of exposure:
24 hours
Doses:
Single dose: 2000 mg/kg
No. of animals per sex per dose:
6 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
All animals remaind asymptomatic during the observation period.
Body weight:
Body weight gain was observed.
Gross pathology:
No data.

Applicant's summary and conclusion