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Toxicological information

Basic toxicokinetics

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
3 males and 2 females
Control animals:
no
Positive control:
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