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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Acceptable, reasonably well documented publication Deviations: - missing data: an evaluation of the rate and extent of absorption is not given, and an investigation of tissue distribution and metabolic pathway was not conducted. - less tha 95 % of the administered dose was recovered in excreta, and the post-exposure period consisted of only 4 days instead of 7.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1964

Materials and methods

Objective of study:
metabolism
Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.36 (Toxicokinetics)
Version / remarks:
adopted 1988
Deviations:
yes
Remarks:
, please refer to "rationale for reliability incl. deficiencies" above
Principles of method if other than guideline:
Method followed: None specified at the time of conduct
Treated mice were maintained in metabolic cages, expired air was collected in two successive absorption vessels containing either sodium or potassium hydroxide solution, and isotope recovery in urine and faeces was measured.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 1-14C radiolabelled sorbic acid
Radiolabelling:
yes

Test animals

Species:
mouse
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: about 22 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on exposure:
- Volume administered: 0.5 ml
- Specific activity of test substance: 640 000 cpm. or 850 000 cpm.

VEHICLE
- Concentration in vehicle: 0.136 % or 15.5 %; 1280000 or 1700000 c.p.m./mL
Duration and frequency of treatment / exposure:
single administration
Doses / concentrations
Remarks:
Doses / Concentrations:
40 or 3000 mg/kg b.w.
No. of animals per sex per dose:
Low dose: 4 females
High dose: 2 females
Control animals:
no
Details on study design:
- Post dose observation period: 4 days
Details on dosing and sampling:
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: exhaled air, urine, faeces;
- Time and frequency of sampling: exhalation, faeces and urine were collected daily and radioactivity was measured.
- Isotope recovery
- Method type(s) for identification: Chromatography

Results and discussion

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Within 4 days, approx 80 % of the administered radioactivity was expired as radioactive carbon dioxide, only 2.6-5.4 % via urine and less than 1 % via faeces. In urine, 0.7 % of the administered dose could be recovered as unchanged sorbic acid, and 0.2-0.6 % was recovered as muconic acid.
Tox. behaviour: none

Any other information on results incl. tables

Adverse effects on prolonged exposure: none

Applicant's summary and conclusion

Conclusions:
The major metabolic pathway was concluded to be oxidation to CO2 and water.
Decision on results of acute toxicity tests conducted in the framework of this study: substance is well tolerated.
The extrapolation from sorbic acid to potassium sorbate or vice versa is considered not to be restricted in any way, since the determinant of potential toxicity is on the "sorbate" anion.