Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: OECD guidelines No. 401 EEC Directive 92/69 B.1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
rat

Administration / exposure

Vehicle:
other: demineralised water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 070 mg/kg bw
95% CL:
810 - 1 430
Mortality:
Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Clinical signs:
Signs of toxicity related to dose levels:
Apart from mortality, the following phenomena occurred most
frequently: ataxia, hypotonia, piloerection and sniffing.

Hypothermia, flat body posture and loss of righting reflex
were observed before dying. Tremors occurred inconsistently
in females only, excitation and palpebral ptosis only once
in females, and exopthalmos only once in males.

All surviving rats completely recovered within 2 days after
administration of T001625.
Gross pathology:
Effects on organs:
The most commonly observed abnormalities were: vibices or
petechia in the glandular part of the stomach (in both
sexes) or in the stomach (males only); dilatation or
congestion sometimes with red and/or watery content in the
gastro-intestinal tract; dilatation with watery content in
the urinary bladder (in both sexes once only); and moderate
autolysis (in males once only).

Applicant's summary and conclusion

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