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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
Study period:
April 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
single application for 24 hours, on intact and abraded skin, 4 dose levels, 14-day post observation period
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform, no surface treatment
Details on test material:
precipitated, CAS-No.: 112926-00-8
Specific details on test material used for the study:
Zeo 49

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Sex:
not specified
Details on test animals and environmental conditions:
Mature healthy New Zealand White albino rabbits were selected from the stock colony. Animals were individually housed in stainless steel suspended cages with Purina Rabbit Chow and water ad libitum.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
distilled
Details on dermal exposure:
Rabbits were clipped free of hair over the dorsal area. A single dermal application was employed and test sites were occluded with an impervious bandage for 24 hours.
Duration of exposure:
24 h
Doses:
2000, 3000, 4000, 5000 mg/kg bw
No. of animals per sex per dose:
4 in total per dose: 2 with abraded and 2 with inract skin
Control animals:
no
Details on study design:
Animals were observed for reactions at 4 hours after dosing, and then daily for 14 days. Body weights were recorded at dosing and at termination. Rabbits sacrificed were subjected to a gross examination of the viscera.

Results and discussion

Preliminary study:
Four rabbits were clipped free of hair over the dorsal area. A single dermal application at the following levels was employed: 2000, 3000, 4000, and 5000 mg/kg of body weight.
Test sites were occluded with an impervious bandage. After 24 hours, the bandages were removed. The animals were observed for signs of illness or death for up to four days.
Effect levelsopen allclose all
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Sex:
not specified
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
Dermal reactions were limited to slight erythema on day 1 in one rabbit with abraded skin treated with 3000 mg/kg bw. The other 15 animals showed no reactions. There was no dose-dependent relationship.
Body weight:
All rabbits at all dose levels gained weight.
Gross pathology:
Upon necropsy, at day 14, no gross pathology was noted in the viscera.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
As no mortality occured, the LD50 of Zeo 49 was greater than 5000 mg/kg bw.
Executive summary:

Zeo 49 was evaluated for its dermal LD50 in the rabbit. Single applications were made to the intact and abraded skin.