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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Test animals

Species:
other: Rat (Charles River)

Administration / exposure

Vehicle:
other: 1% w/v aqueous methylcellulose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 300 mg/kg bw
Mortality:
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 1
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Clinical signs:
other: Signs of toxicity related to dose levels: Three females dosed at 2000 mg/kg were found dead on Day 2. Clinical signs prior to death comprised hunched posture, piloerection, salivation, unsteady gait, underactivity, and partially closed eyelids seen in
Gross pathology:
Effects on organs:
Macroscopic examination of the decedents treated at 2000
mg/kg revealed congestion (characterised by darkened
tissues/organs or blood vessels injected) of the
subcutaneous tissue, brain and heart in all three animals,
and lungs, liver, spleen, stomach, duodenum, caecum, small
and large intestines in two animals. Pallor of the kidneys
was noted in three animals and of the liver and spleen in
one animal. Fluid contents (clear/brown or clear watery
with black specks) were noted in the stomach and duodenum of
three animals and the small intestine of two animals. In
addition, an enlarged/swollen/thickened heart, small
(atrophy) caecum and gaseous distension of the stomach were
also noted in one animal.


Macroscopic examination at study termination on Day 15
revealed pallor of the lungs in two females treated at 300
mg/kg and congestion (darkened tissue/organ) in the spleen
of two animals treated at 2000 mg/kg. No abnormalities were
revealed in any other animal at the macroscopic examination
at this time.

Applicant's summary and conclusion

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