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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No guideline followed. Not a GLP study. Evaluation of clinical symptoms was not reported. The identity of the test material was not established.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Graded doses of the test material were applied to the skin of rabbits and observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Details were not provided clearly and completely except a handwritten note "50% in silicone oil" on page 1 of the entire report summarizing the conclusions from 3 different toxicity studies. In the dermal toxicity study report, the test material is stated as Cedox TS-50.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
Eight rabbits equally divided as to sex, weighing 2317 to 2831 gms were used. No other details were provided.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The hair was clipped from the back of each rabbit. the skin was abraded for 1/2 of the rabbits in each group. The rabbits were divided into four groups of 2 rabbits (one male and one female) for each group (dose levels of 1000, 2000, 3000, and 4000 mg/kg). The test material was applied as received to the backs in appropriate doses. The site of application was covered with gauze bandaging and occluded with Saran wrap.
Duration of exposure:
14 days
Doses:
1000, 2000, 4000 and 8000 mg/kg
No. of animals per sex per dose:
one male and female per dose.
Control animals:
no
Details on study design:
No other details provided
Statistics:
None

Results and discussion

Preliminary study:
The rabbits were observed for death at 24 hours and daily thereafter for a total of 14 days. It was concluded that the acute dermal toxicity (LD50) value in albino rabbits would be greater than 8000 mg/kg.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
other:
Remarks on result:
other: Not clear as to how the dose formulations were calculated and prepared from the test item.
Mortality:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity (LD50) value in albino rabbits would be greater than 8000 mg/kg.
Executive summary:

There were no mortalities.

Although the study concluded that the LD50 value in rabbits was greater than 8000 mg/kg, due to the non-GLP nature of the experiment, and the lack of some details on the test item and some experimental conditions, the level of confidence in the conclusions is somewhat less reliable.