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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Reference Type:
other: monograph provided by ECHA
Title:
Endpoint record:Acute toxicity dermal
Author:
ECHA
Year:
2010
Bibliographic source:
Document from ECHA

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
There is no need to add in this field.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
75 - 95% (typical 88%, verified by UV/visible spectrum, Infrared (IR) spectrum, Nuclear Magnetic Resonance (NMR), and Mass spectrum.)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Nothing to add in this field.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
The test substance was moistened in water before application.
A dose of 2 000 mg/kg was applied under semiocclusive dressing to an area of shorn skin on the back and flank for 24 hours.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
limit test
Statistics:
no data

Results and discussion

Preliminary study:
Nothing to add in this field.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Observation period: 14 days
Mortality:
no death
Clinical signs:
No signs of systemic toxicty were observed during the observation period.
Body weight:
All animals showed expected gain in bodyweight.
Gross pathology:
No signs of skin irritation were noted during the study. No abnormalities were noted at necropsy.
Other findings:
Nothing to add in this field.

Any other information on results incl. tables

Mortality: No deaths were recorded.

Clinical observations: No clinical signs of toxicity were noted.

Morphological findings: No signs of skin irritation were noted during the study. No abnormalities were noted at necropsy.

Comment: All animals showed expected gain in bodyweight.

LD50: > 2 000 mg/kg

Result: The test chemical was of low dermal toxicity in rats.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material has low toxicity via acute dermal toxicity study in rats.
Executive summary:

According to OECD TG 402, the acute dermal toxicity test was well conducted and the results indicated the test material has very low toxicity in rats.