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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Commission Directive 96/54/EC, Method B1.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: Rat, Wistar strain.

Administration / exposure

Vehicle:
other: Arachis oil BP.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 500 mg/kg bw; Number of animals: 2; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 2; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Preliminary Study:


There were no deaths or clinical signs of toxicity at dose
levels of 500 and 2000 mg/kg bodyweight.


Based on this information a dose level of 2000 mg/kg
bodyweight was selected for the main study.



Main study:


There were no deaths.


No clinical signs of toxicity were noted during the study.


All animals showed expected gains in bodyweight over the
14-day study period.
Gross pathology:
Effects on organs:
Main Study:


No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU