L-Sorbose, 6-deoxy-6-(formylamino)-

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

89182-60-5

EC Number:

618-251-5

Cas Number:

89182-60-5

IUPAC Name:

89182-60-5

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.