Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-980-0
EC Name:
-
Cas Number:
129499-78-1
Molecular formula:
C12H18O11
IUPAC Name:
(5R)-5-[(1S)-1,2-dihydroxyethyl]-4-hydroxy-3-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-2,5-dihydrofuran-2-one

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Vehicle:
other: Eau distillée

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
MORTALITÉ:
Aucune mortalité pendant l'essai.
SIGNES CLINIQUES:
Des selles molles ont étés observées pendant l'essai.
POIDS CORPORELS:
Aucun changement n'a été noté
Gross pathology:
Effects on organs:
Aucun effet sur les organes.

Applicant's summary and conclusion

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