6-deoxy-L-mannose

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data taken from accepted publication with limited details on methods and results.

Data source

Reference

Reference Type:

publication

Title:

Abnormal intestinal permeability to sugars in diabetes mellitus

Author:

Mooradian AD, Morley JE, Levine AS, Prigge WF, and Gebhard RL

Year:

1986

Bibliographic source:

Diabetologia, 29:221-224

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

basic toxicokinetics

Principles of method if other than guideline:

The excretion of the test substance in humans was studied.

GLP compliance:

no

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

Details on test material:

-Purity: Not reported

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 13
- Sex: Male
- Age: mean age 52.4±1.8 years (range 26-74)

Ethical approval:

other: subjects were given informed consent

Route of exposure:

oral

Reason of exposure:

intentional

Details on exposure:

Males were given a single ingestion of 1.0 g. The solution was hyperosmolar (1505 mOsm/L) to enhance oligosaccharide permeability. The subjects ingested the undiluted solution within a period of 3 minutes and followed this with an equal volume of water. Patients remained fasting for 2 additional hours and then took water ad libitum to facilitate adequate urine output. A 5-hour collection of urine was obtained.

Examinations:

- Urine analysis: Total urine excretion was examined.

Results and discussion

Outcome of incidence:

Excretion was 84.3±18.4 mg/5 hours with a range of 31.5-290 mg/5 hours.

Applicant's summary and conclusion

Conclusions:

Excretion in humans was 84.3±18.4 mg/5 hours with a range of 31.5-290 mg/5 hours.

Executive summary:

The excretion of the test substance in humans was studied. Thirteen males were given an oral sugar solution containing 1 g test substance. The solution was hyperosmolar (1505 mOsm/L) to enhance oligosaccharide permeability. Subjects ingested the undiluted solution within a period of 3 minutes and followed this with an equal volume of water. Patients remained fasting for 2 additional hours and then took water ad libitum to facilitate adequate urine output. A 5-hour collection of urine was obtained. Excretion was 84.3±18.4 mg/5 hours with a range of 31.5-290 mg/5 hours.