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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Test animals

Species:
other: Rat (Wistar)

Administration / exposure

Vehicle:
other: Propylene glycol, specific weight 1.036

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
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 1
Clinical signs:
other: Signs of toxicity related to dose levels: Clinical signs observed during the study period were as follows: Dose level Clinical signs 2000 mg/kg Females: Lethargy, ventral lateral recumbency, uncoordinated movements, slow breathing and watery disc
Gross pathology:
Effects on organs:
Macroscopic post mortem examination of the animals that were
found dead or sacrificed for ethical reasons during the
study revealed: stomach: thickening of the limiting ridge;
urinary bladder: enlarged and several reddish focus/foci;

prostate: enlarged, dark red or reddish discolouration,
moist; seminal vesicles: enlarged and/or moist; spleen:
reduced in size; body cavities containing watery fluid;
thymus: light red focus/foci; Kidney: pelvic dilation. Since
pelvic dilation of the kidney is occasionally seen among
rats of this age and strain, the toxicological significance
of this finding is doubted. No treatment related

abnormalities were found at macroscopic examination of the
surviving animals.

Applicant's summary and conclusion

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