Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb-Mar 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-deoxy-1-formamido-D-glucitol
EC Number:
618-251-5
Cas Number:
89182-60-5
Molecular formula:
C7 H15 N O6
IUPAC Name:
1-deoxy-1-formamido-D-glucitol
Details on test material:
N-Formylaminosorbit, white powder, Batch: BXR2DEX, content: 98.8%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
demineralized water
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
40, 200, 1000 mg/kg in an application volume of 10 ml/kg
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects observed up to the highest dose

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No animal died unscheduled within the study. Up to and including the highest dose group no clinical signs as well as no effects on body weight gain, food intake, hematology and clinical chemistry were observed. FOB and MA/LMA didnot indicate neurotoxicity up to 1000 mg/kg. Moreover, no substance-related adverse effects were detected on organ weights and at necropsy and histopathology.

Applicant's summary and conclusion

Executive summary:

N-Formylaminosorbit was administered daily via gavage in demineralized water to 5 male and 5 female Wistar rats per dose group, in doses of 0, 40, 200 and 1000 mg/kg body weight for a period of 4 weeks. The animals were regularly observed and weighed. Food intake was determined. FOB as well as MA/LMA tests and clinical laboratory investigations on blood samples were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed.

Survival was not affected by treatment and no adverse effects were detected up to and including the highest dose group.

Therefore, the NOAEL in male and female rats was established to be 1000 mg/kg body weight/day.