Registration Dossier
Registration Dossier
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EC number: 215-664-9 | CAS number: 1338-41-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary source available.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Triolate
- Author:
- Elder, R.L., ed.
- Year:
- 1 985
- Bibliographic source:
- Journal of the American College of Toxicology, Vol4, 3, 1985, p 65-121
- Reference Type:
- publication
- Title:
- Sorbitan monostearate metabolism. Lack of deposition upon chronic feeding
- Author:
- Wick, A.N. and Joseph, L.
- Year:
- 1 953
- Bibliographic source:
- J Agric Food Chem 1, 398
Materials and methods
- Objective of study:
- distribution
- Principles of method if other than guideline:
- The accumulation and deposition of sorbitan stearate in body fat was studied.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan stearate
- EC Number:
- 215-664-9
- EC Name:
- Sorbitan stearate
- Cas Number:
- 1338-41-6
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- 1,4-anhydro-6-O-stearoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): sorbitan stearate
- Analytical purity: not specified
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- 28 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1% in diet = 100 mg/kg bw (calculation based on the assumption of a an average rat body weight of 200 g and an average daily uptake of 20 g feed/animal)
- No. of animals per sex per dose / concentration:
- 9
- Control animals:
- not specified
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (distribution)
- Tissues and body fluids sampled: body fat; carcasses were frozen, dehydrated, and extracted for the test substance with hot chloroform. The radioactivity of crude fat, fatty acids, glycerol, and residue was determined.
- Time and frequency of sampling: at termination of the study, when the rats were killed
Results and discussion
Main ADME results
- Type:
- distribution
- Results:
- the test substance did not accumulate in body fat stores
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- A small portion (0.35 to 0.49 %) of the radioactivity was in crude fat, 0.15 to 0.32 % was in fatty acids, 0.01 to 0.07 % was found in glycerol, and 0.04 to 0.09 was found in the residue.
Applicant's summary and conclusion
- Conclusions:
- Administration of the test substance to rats via diet for 28 days did not result in an accumulation in body fat stores.
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