Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
ZEO 49, ZEOSYL 113, ZEOSYL 200, and ZEOFREE 153 (not further specified)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Four animals per group used, two each treated on the intact and abraded skin: The substance was mixed with distilled water to form an aqueous paste
Duration of exposure:
24 h
Doses:
2000, 3000, 4000, and 5000 mg/kg
No. of animals per sex per dose:
4 per dose group
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No systemic signs of toxicity were observed.
Gross pathology:
Organ toxicity was not observed.
Other findings:
Local effect: very slight erythema (score 1 of 4), reversible after 2 days (ZEO 49), after 4 d (ZEOSYL) or 5 d (ZEOFREE) in one or a few animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met