6-deoxy-L-mannose

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: U.S. FDA, Redbook 2000: IV.C.2: Acute Oral Toxicity Tests (1993)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-deoxy-L-mannose

EC Number:

222-793-4

EC Name:

6-deoxy-L-mannose

Cas Number:

3615-41-6

Molecular formula:

C6H12O5

IUPAC Name:

6-deoxy-L-mannose

Test material form:

other: crystalline powder

Details on test material:

- Purity: 98%

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Age at study initiation: approximately 10 weeks old
- Weight at study initiation: 209.0-217.5 g
- Fasting period before study: approximately 17.5-18.25 hours prior to dosing, with food being returned to the rats approximately 2.75-3 hours after dosing
- Housing: Individually in solid-bottom caging with bedding and appropriate species-specific enrichment.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26ºC (68-79ºF)
- Humidity (%): 30-70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): approximate 12-hour light/dark cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL per kg of body weight. Individual dose volumes were calculated using the fasted body weights obtained prior to dosing.

DOSAGE PREPARATION (if unusual): The dosing formulations were sonicated prior to dose administration and stirred throughout the dosing procedure.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, or abnormal behavior. Except as noted below, animals were weighed on test days -1, 1, 8, and 15, and were observed for clinical signs at the beginning of fasting, just before dosing (test day 1), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter. Clinical observations were inadvertently not recorded on test day 5. The daily animal health observations recorded on those days, and the clinical observations collected on the preceding and succeeding days, were sufficient to assess the animals’ conditions.
- Necropsy of survivors performed: yes

Statistics:

Not applicable

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: highest dose tested

Mortality:

No deaths occurred during the study.

Clinical signs:

other: There were no clinical abnormalities observed.

Gross pathology:

No gross lesions were present in the rats at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats): >5000 mg/kg

Executive summary:

A single dose of the test substance was administered by oral gavage to fasted female rats at a dose of 5000 mg/kg. The five rats were dosed on the same day. All rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. The rats were necropsied to detect grossly observable evidence of organ or tissue damage. There were no incidents of mortality, clinical abnormalities, or overall (test day 1-15) body weight loss. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the test substance was not considered acutely toxic via the oral route of exposure in female rats at a dose level of 5000 mg/kg. In the absence of test substance related mortality, an LD₅₀ was not calculated.