Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.1bis (Fest-Dosis-Methode)
GLP compliance:
yes
Test type:
fixed dose procedure

Test animals

Species:
other: rat, Sprague-Dawley ICO OFA.SD (IOPS Caw.)

Administration / exposure

Vehicle:
corn oil
No. of animals per sex per dose:
Preliminary sighting study: 2 (female)
Main study: 5 (male)
Main study: 5 (female)
Details on study design:
Preliminary sighting study:
The test substance was administered at the doses of 500 and
50 mg/kg b.w. One female was used for each dose-level.

Main study:
The test substance was administered at the dose-level of

50 mg/kg b.w. to a group of 5 males and 5 females.

Results and discussion

Preliminary study:
Species/strain: rat, Sprague-Dawley ICO OFA.SD (IOPS Caw.)
500 mg/kg bw: Evident toxicity: Y; Mortality: Y
50 mg/kg bw: Evident toxicity: Y; Mortality: N
mg/kg bw: Evident toxicity: ; Mortality:

Observations:
50 and 500 mg/kg b.w.: Hypocactivity and piloerection.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
50 mg/kg bw
Dose descriptor:
other: 50 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: 0; No. of deaths: 0; No. of animals used: 5
Gross pathology:
Effects on organs:
Macroscopic examination of the main organs of all animals
revealed no apparent abnormalities.
Other findings:
No clinical signs and no mortality were observed at

50 mg/kg b.w.

Body weight gain of animals was not affected by treatment.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information