Registration Dossier

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:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
24h exposure
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ziram
- Lot no.: 8331 AA
- Purity: 98.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Source: A. Smith, Warlingham, Surrey and Froxfield Rabbits, England
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.2-2.9 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24h
Doses:
2 g/kg
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occured.
Clinical signs:
There were no signs of toxicity.
Body weight:
A loss in bodyweight was recorded for two females on Day 8. All other rabbits achieved anticipated bodyweight gains throughout the study.
Gross pathology:
Pale renal cortices were observed in the kidneys of one male at post-mortem. Terminal autopsy revealed no other macroscopic abnormalities.
Other findings:
Dermal responses:
Slight erythema only was observed in two males and two females. The reactions had resolved completely by Day 3 or 4 of the study. The remaining three males and three females showed no response to treatment.

Applicant's summary and conclusion