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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Specific details on test material used for the study:
Not specified

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Not specified
Duration of exposure:
Not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6 total
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
one animal receiving this dose died
Clinical signs:
Isolated instances of lethargy, diarrhea, ptosis, and yellow nasal discharge, and moderate erythema (six rabbits), slight edema (one rabbit), and moderate edema (five rabbits).
Body weight:
Not specified
Gross pathology:
At necropsy, gross observations were normal for three animals. Necropsy of the remaining animals revealed the following changes: red areas in the intestines, mottled liver, white nodules in the liver, dark areas in the lungs, mottled kidneys, pale kidneys, dark spleen, and dark areas in the stomach.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated for acute dermal toxicity in rabbits using a limit test dose of 5000 mg/kg bw. The LD50 of the test substance was greater than this dose. According to GHS criteria for acute dermal toxicity, criteria for classification for acute dermal toxicity are not met.