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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:
9 to 23 December 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24 February 1987
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
The substance is the Source of the read-across.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Free access to mains drinking water and food was allowed throughout the study.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
Test material, moistened with arachis oil, was applied evenly to an area of shorn skin (ca. 10% of body surface area). The area was covered with surgical gauze and self-adhesive bandage. The animals were caged individually for the 24 h exposure period. After 24 h, the bandage was removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil to remove residual test material.
Duration of exposure:
24 h.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female.
Control animals:
no
Details on study design:
Animals observed for death or overt signs of toxicity for 14 days.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (dermal, rat) > 2000 mg/kg.