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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Test animals

Species:
other: Rat (Wistar strain Crl: (WI))

Administration / exposure

Vehicle:
other: Propylene glycol.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Mortality:
Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 200 mg/kg bw; Number of animals: 3; 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:
No mortality occurred among males and females dosed at 200
mg/kg body weight. All females treated at 2000 mg/kg were
found dead within 6 hours or on day 2 post-treatment.


Lethargy was noted in all animals dosed at 200 mg/kg on day
1 only. Clinical signs including lethargy, tremors, muscle
twitching, ventro lateral recumbency, shallow respiration,
uncoordinated movements, ptosis, piloerection and/or hunched
posture were noted among the females dosed at 2000 mg/kg.
Gross pathology:
Effects on organs:
No treatment-related abnormalities were found at macroscopic
post mortem examination of the animals.

Applicant's summary and conclusion

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