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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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The appropriate amount of test substance (200 or 2,000 mg/kg bw) was applied evenly over a dose area of approximately 10% of the body surface and covered with a gauze pad. After 24h of exposure to the substance, the pads were removed and the test sites were gently cleansed of any residual test substance.
Duration of exposure:
24h
Doses:
200 or 2,000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
200 mg/kg bw: 0/10
2,000 mg/kg bw: 9/10

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
An acute dermal toxicity test was conducted with rats to determine the potential for IR9804 to produce toxicity from a single topical application. Under test conditions of this study, the single dose acute dermal LD50 of the test substance is between 200 and 2,000 mg/kg bw of body weight in male and female rats.