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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Data waiving:
other justification
Justification for data waiving:
other:

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 2004/73, B.1.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1

Test animals

Species:
other: HanRcc:WIST (SPF) rats

Administration / exposure

Vehicle:
other: Desiccated corn oil.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 2 000 mg/kg bw
Mortality:
Female: 300 mg/kg bw; Number of animals: 6; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Clinical signs:
Signs of toxicity related to dose levels:
After the 2000 mg/kg administration moderated to marked
sedation and ventral recumbency was observed in all animals.
Other effects were absence of reflexes, poor coordination
and bradypnea observed in two animals in different timings.
The three animals were killed in extremis after 5 hours of
treatment.


For the 300 mg/kg dosage slightly ruffled fur in three
animals and hunched posture in one animal was observed up to
5 hours. No death was observed.

The body weights were within the normal range for the strain
and age.
Gross pathology:
Effects on organs:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU