Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP complianced.

Data source

Reference
Reference Type:
other: Inquiry result from ECHA
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/CEE, B.1
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
Sex:
male/female

Administration / exposure

Vehicle:
water
Remarks:
distilled

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 1000mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2000mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related ot dose levels:
MORTALITE:
Aucune mortalite pendant l'essai.
SIGNS CLINIQUES:
Des selles molles ont etes observees pendant l'essai.
POIDS CORPORELS:
Aucun changement n'a ete note.
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