Syrups, wheat, hydrolyzed starch

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

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

Adequacy of study:

supporting study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation for a read-across substance.

Data source

Reference

Reference Type:

publication

Title:

Metabolism and caloric utilization of orally administered maltitol-14C in rat, dog, and man.

Author:

HH Rennhard & JR Bianchine

Year:

1976

Bibliographic source:

J. Agric. Food Chem., Vol. 24, No. 2, 287-291

Materials and methods

Objective of study:

excretion

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 417 (Toxicokinetics)

Version / remarks:

-reliability scoring based on 1984 guideline

Deviations:

yes

Remarks:

-purity and physico-chemical properties of test article, and housing and feeding conditions were not reported; only 1 dose tested; observation period should be 7 days or up until 95% of the absorbed dose for excretion studies, whichever comes first

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

4-O-α-D-glucopyranosyl-D-glucitol

EC Number:

209-567-0

EC Name:

4-O-α-D-glucopyranosyl-D-glucitol

Cas Number:

585-88-6

IUPAC Name:

4-O-alpha-D-glucopyranosyl-D-glucitol

Details on test material:

- Name of test material (as cited in study report): Maltitol
- Physical state: Liquid (solution)
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not reported
- Specific activity (if radiolabelling): Not reported
- Locations of the label (if radiolabelling): Maltitol-U-14-C
- Expiration date of radiochemical substance (if radiolabelling): Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Radiolabelling:

yes

Remarks:

maltitol-U-14C

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: Not reported
- Weight at study initiation: 95 to 200 g
- Fasting period before study: Not reported
- Housing: Not reported
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
-Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: "solution" not specified

Details on exposure:

Details on exposure were not provided.

Duration and frequency of treatment / exposure:

Single administration

Doses / concentrations

Remarks:

Doses / Concentrations:
1 mL of the radioactive maltitol solution (125 to 260 mg/kg bw, 49.7 μCi).

No. of animals per sex per dose / concentration:

3 males and 2 females

Control animals:

no

Positive control reference chemical:

None used.

Details on study design:

Details on study design were not provided.

Details on dosing and sampling:

PHARMACOKINETIC STUDY (excretion)
- Tissues and body fluids sampled: urine and faeces obtained from all rats; breath was sampled in one rat
- Time and frequency of sampling: Sampled from 0 to 14 hours, 14 to 24 hours, 24 to 48 hours, and 48 to 72 hours.
- Other: Caloric utilization was measured.

Results and discussion

Preliminary studies:

None used.

Toxicokinetic / pharmacokinetic studies

Details on excretion:

See Table 1 under remarks on results section.

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

Approximately 13% of total faecal radioactivity was due to volatile fatty acids.

Any other information on results incl. tables

Table 1: Recovery of Radioactivity following Oral Administration of Maltitol-U-14C to Rats

Rat no.	Interval (hr)	Percent of administered radioactivity recovered
		^14CO2	Urine	Faeces
1	0 to 72	45.5	9.40	13.22
2	0 to 72	-	4.03	11.55
3	0 to 72	-	3.94	4.38
4	0 to 48	-	4.34	4.96
5	0 to 48	-	3.90	4.29

 

Caloric utilization in rat no.1 was reported to be 76% (based on recovery of ¹⁴CO₂of rat no.1 and catabolic transformation factor of 0.6 for readily absorbed compounds such as acetate and glucose). The total 14C recovery was calculated to be approximately 98% (based on caloric utilization and urine and faeces of rat no.1).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results