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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1969-05-27 to 1969-06-04
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Toxicological Evaluation of Some Food Colours, Emulsifiers, Stabilizers, Anti-Caking Agents and Certain Other Substances
Author:
World Health Organization
Year:
1969
Bibliographic source:
FAO Nutrition Meetings Report Series No. 46A WHO/FOOD ADD/70.36

Materials and methods

Objective of study:
excretion
metabolism
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test animals were fed Stearoyl lactylate, calcium salt and Stearoyl lactylate, sodium salt and metabolism and excretion were investigated
- Short description of test conditions: The metabolism of test chemical mixture was quantified using C14-labelled lactic acid with stearoyl lactylate containing C14 in the lactic acid moiety. The metabolism of a mixture of one stearic acid and C14 labelled lactic acid with stearoyl lactylate containing C14 in the lactic acid moiety was compared.
- Parameters analysed / observed: C14 excretion through CO2 and lactic acid
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Reference substance 002
Cas Number:
5793-94-2
Specific details on test material used for the study:
OTHER SPECIFICS
Test item for metabolism experiment: mixture of 1 Stearic acid and C14-labelled Lactic acid was compared with Stearoyl lactylate containing C14 in the lactic acid moiety.
Test item for excretion experiment: Stearoyl lactylate, calicum salt and Stearoyl lactylate, sodium salt.

RADIOLABELLING INFORMATION (if applicable)
- Locations of the label: C14 label located in the Lactic acid moiety
Radiolabelling:
yes
Remarks:
C14 in the lactic acid moiety

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on exposure:
Not reported
Duration and frequency of treatment / exposure:
Not reported
No. of animals per sex per dose / concentration:
Not reported
Positive control reference chemical:
Not reported
Details on study design:
- Dose selection rationale: Not reported
- Rationale for animal assignment (if not random): Not reported
Details on dosing and sampling:
TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: faeces, breath (CO2)
- Time and frequency of sampling: not specified

METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled (delete / add / specify): faeces
- Time and frequency of sampling: Not specified
Statistics:
Not reported

Results and discussion

Main ADME resultsopen allclose all
Type:
metabolism
Results:
Lactate derived from stearoyl lactylate is metabolized normally after prompt and quantitative release prior to absorption.
Type:
excretion
Results:
Traces of lactate in the faecal fat showed good utilization of the stearic acid moiety and of the calcium.
Type:
excretion
Results:
58% of the C14 in the physical mixture was excreted in the first 24 hours as CO2 through the lungs and 61% of the lactic acid moiety similarly. There was no difference in C14 distribution and excretion in animals receiving lactate in either form.

Toxicokinetic / pharmacokinetic studies

Details on excretion:
Rats fed the sodium or calcium salt excreted only traces of lactate in the faecal fat showed good utilization of the stearic acid moiety and of the calcium.

Applicant's summary and conclusion

Conclusions:
In conclusion it has been shown that calcium stearoyl lactylate will be hydrolised into stearic acid and lactic acid, which gets further metabolised an excreted as CO2.
Executive summary:

In in vitro tests with lipase by Hodge et al. (1961), ready hydrolysis into stearic and lactic acid was observed. Rats fed the sodium or calcium salt excreted only traces of lactate in the faecal fat showed good utilization of the stearic acid moiety and of the calcium.

Experiments comparing the metabolism of a mixture of one stearic acid and C14 labelled lactic acid with stearoyl lactylate containing C14 in then lactic acid moiety, showed that 58% of the C14 in the physical mixture was excreted in the first 24 hours as CO2 through the lungs and 61% of the lactic acid moiety similarly. There was no difference in C14 distribution and excretion in animals receiving lactate in either form. Thus lactate derived from stearoyl lactylate is metabolized normally after prompt and quantitative release prior to absorption.

In conclusion it has been shown that calcium stearoyl lactylate will be hydrolised into stearic acid and lactic acid, which gets further metabolised an excreted as CO2.

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