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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:
07 July 2016 - 21 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
other: DOT 49 CFR 173.132(b)(2)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
Approximately 24 hours prior to application of the test article, the dorsal area of the animals were clipped free of hair. The prepared site was approximately 10% of the body surface and remained intact. A single dose (2000mg/kg) of the test material, moistened with 1.0 ml of corn oil, was applied and remained in contact with the skin for 24 hours at which time the wrappings were removed. Residual test material was removed by gently washing with corn oil.


Duration of exposure:
24 hours
Doses:
2000 mg/kg of body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Dermal responses were recorded at 24 hours post-dosing and on Day 14. Animals were observed for mortality, toxicity and pharmacological effects at one and four hours post-dosing and once daily thereafter for 14 days. Body weights were recorded pre-test, weekly, and at termination. All animals were examined for gross pathology.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Immediately following unwrapping, very slight erythema and edema were absent. By Day 14, erythema and edema were absent.
Body weight:
All ten animals gained body weight by study termination.
Gross pathology:
The gross necropsy revealed no observable abnormalities.
Other findings:
No abnormal physical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The dermal LD50 of RD 14153 is greater than 2000 mg/kg of body weight in rats.