Registration Dossier

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
Principles of method if other than guideline:
OECD No.423 (2001) "Acute Toxicity-Oral, Acute Toxic Class
Method"

EC, Council Directive 67/548/EEC, Annex V, B.1 tris (2004)
"Acute Oral Toxicity"

EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity - Acute
Toxic Class Method"

JMAFF guidelines (2000) including the most recent partial
revisions.
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:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Hunched posture and/or uncoordinated movements were noted in
all animals on day 1.
Gross pathology:
Effects on organs:
No abnormalities were found at macroscopic post mortem
examination of the animals.

Applicant's summary and conclusion

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