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:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
(3R,4S,5R,6R)-3,4,5-tris[(trimethylsilanyl)oxy]-6-{[(trimethylsilanyl)oxy]methyl}tetrahydro-2H-pyran-2-one
EC Number:
608-732-8
Cas Number:
32384-65-9
Molecular formula:
C18 H42 O6 Si4
IUPAC Name:
(3R,4S,5R,6R)-3,4,5-tris[(trimethylsilanyl)oxy]-6-{[(trimethylsilanyl)oxy]methyl}tetrahydro-2H-pyran-2-one

Test animals

Species:
rat
Strain:
other: Crl:WI(Han)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % aqueous hydroxyethylcellulose (Natrosol® 250 HX)
Doses:
300 and 2000mg/kg
No. of animals per sex per dose:
3

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 300 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present study, a single oral administration (gavage) of
BI 10773 TMS-LACTON at doses of 300 (females) and 2000 mg/kg (males and females) was
associated with no signs of toxicity and no deaths. Thus, the approximate lethal dose (ALD)
is above 2000 mg/kg in male and female rats.