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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Analogue substance (refer to IUCLID chapter 13)
IUPAC Name:
Analogue substance (refer to IUCLID chapter 13)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 2 % solution of CMC
Details on dermal exposure:
Total number of animals: 5 males, 5 females
Duration of exposure:
Single occlusive dermal application followed by an observation period of 15 days
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Number of animals per group/per dose: 5 males, 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Clinical signs:
other: No signs or symptoms of systemic toxicity or local irritation effects were observed.
Gross pathology:
No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information
Conclusions:
The acute dermal toxicity test was carried out with the analogue substance. As a result of the test, the LD50 of the analogue substance was determined to be greater than 2000 mg/kg. Due to the structural similarity of the analogue substance and the substance subject of registration it can concluded that the LD50 for the substance subject of registration will be > 2000 mg/kg, too.