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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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/EEC, B.1.tris
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: rat, Wistar HsdCpb:Wu

Administration / exposure

Vehicle:
other: water with 2% Cremophor EL

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No clinical signs were observed in animals treated with 300
mg/kg bw.


The following clinical signs were observed in animals
treated with 2000 mg/kg bw.: decreased motility, poor
general condition, lateral position, abdominal position,

tachypnea and dazed condition


There were no toxicological effects on body weight or body
weight gain in animals treated with 300 mg/kg bw. and in the
surviving animal treated with 2000 mg/kg bw.
Gross pathology:
Effects on organs:
The necropsies performed at the end of the study revealed no
particular findings in animals treated with 300 mg/kg bw.



No gross pathological changes were observed in animals
treated with 2000 mg/kg bw. that died during the observation
period or in the surviving animal sacrificed at the end of
the study period.

Applicant's summary and conclusion

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