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EC number: 297-083-0 | CAS number: 93334-10-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (no data on test substance purity)
Data source
Reference
- Reference Type:
- publication
- Title:
- The metabolism of sorbitan monostearate
- Author:
- Wick, A., N.
- Year:
- 1 953
- Bibliographic source:
- Food research, 1953, 18:79-84
- Report date:
- 1952
Materials and methods
- Objective of study:
- distribution
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- (analytical purity of test substance not given, limited documentation)
- 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:
- C24H46O6
- IUPAC Name:
- 1,4-anhydro-6-O-stearoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): sorbitan monostearate
- Locations of the label (if radiolabelling): polyol residue or stearic acid fraction
- Analytical purity: not specified
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- C14
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 190-210 g
- Fasting period before study: no fasting
- Diet: Purina Laboratory Chow
- Individual metabolism cages: yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water emulsion or corn oil because of different absorption properties
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): absorption from the intestinal tract by itself is not necessarily identical with its route when dissolved in oil or in water
- Concentration in vehicle: dose dependent
- Amount of vehicle (if gavage): 4 mL corn oil or 8 mL water - Duration and frequency of treatment / exposure:
- single exposure, 48 h observation time
Doses / concentrations
- Remarks:
- Doses / Concentrations:
dependent on the experiment: 100, 240, 258, 263, 303, 307, 400 or 1293 mg in 4 or 8 mL vehicle (0.5-6.5 mg/kg bw)
- No. of animals per sex per dose / concentration:
- 1/experiment
- Control animals:
- no
- Details on study design:
- 11 different experiments were performed: In experiments 1 to 6 the polyol was labeled. For experiment 1 and 2, the test substance was emulsified in water, for 3 to 6 in corn oil. In experiments 7 to 11 the stearate was labeled. For experiment 7 to 9, the test substance was emulsified in water, for 10 and 11 in corn oil.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, plasma, serum or other tissues, cage washes, bile
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, faeces, liver, kidneys, intestinal tract, hind lend muscle or entire carcas for fat, CO2
- Time and frequency of sampling: CO2 for 48h in 6h intervals, others after 48h
- From how many animals: (samples pooled or not) single samples
- Method type(s) for identification: by BaCO3 obtained directly or by dry combustion, or by direct counting
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- When administerd in corn oil, 90% of the test substance is hydrolysed in the intestinal tract and after its absorption. The resulting anhydrid is poorly absorbed. When administered in water only 50% are hydrolyzed. The anhydrids of sorbitol were largly excreted into the urine before they could be completely oxidized to CO2.
- Details on distribution in tissues:
- 5-7% of the administered C14 that was fed in corn oil was found in the tissue.
Fractionation of the crude fat extract of tissues excluding the intestinal tract indicated that less than 0.1% of the fed C14 may represent sorbitans derived from fed sorbitan monostearate or sorbitan esters synthesized from circulating sorbitan.
- Details on excretion:
- Urine contains 44-66% of the fed C14 as sorbitol anhydrids.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Stearic acid and anhydrids of sorbitol
Any other information on results incl. tables
Table 1: Percent distribution of radioactivity 48 hours after oral administration of C14 labeled sorbitan monostearate:
|
Polyol labeled |
Stearate labeled |
|||||||||
Experiment number |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
Expired CO2 |
15 |
14 |
18 |
19 |
24 |
20 |
18 |
7 |
12 |
33 |
21 |
Urine |
25 |
16 |
66 |
66 |
50 |
44 |
1 |
1 |
1 |
1 |
1 |
Stool |
|||||||||||
CHCl3 soluble |
31 |
54 |
7 |
6 |
7 |
8 |
75 |
76 |
69 |
37 |
33 |
CHCL3 insoluble |
17 |
12 |
12 |
8 |
10 |
12 |
3 |
5 |
4 |
2 |
2 |
Combined tissues |
-- |
3 |
6 |
7 |
5 |
7 |
-- |
10 |
15 |
32 |
41 |
Total recovery |
88 |
99 |
109 |
106 |
96 |
91 |
97 |
99 |
101 |
105 |
98 |
Exp. 1, 2, 7-9: test substance administered in water
Exp. 3 -6, 10, 11: test substance administered in corn oil
A small amount (3 -7%) of the ingested radioactivity was recovered in the tissues 48 hours after the feeding of the labeled polyol. Under similar conditions a 4- to 6 -fold increase in C14 deposition occured by feeding the stearate labeled compound when dissolved in corn oil. The percentage of the injected C14 in the crude fat was 0.76 and 0.46% (see Table 2):
Table 2: Percent distribution of radioactivity in tissues 48 hours after oral administration of C14 labeled sorbitan monostearate:
|
Polyol labeled |
Stearate labeled |
|||||||
Experiment number |
2 |
3 |
4 |
5 |
6 |
8 |
9 |
10 |
11 |
Liver |
|||||||||
CHCl3 soluble |
0.06 |
0.08 |
0.09 |
0.1 |
0.11 |
1.38 |
1.45 |
4.3 |
4.7 |
CHCL3 insoluble |
0.23 |
0.52 |
0.55 |
0.57 |
0.50 |
0.35 |
0.62 |
0.92 |
1.82 |
Kidneys |
|||||||||
CHCl3 soluble |
0.01 |
0.01 |
0.02 |
0.08 |
0.03 |
0.18 |
0.05 |
0.14 |
0.18 |
CHCL3 insoluble |
0.02 |
0.05 |
0.05 |
0.05 |
0.05 |
0.05 |
0.14 |
0.09 |
0.49 |
Intestines |
|||||||||
CHCl3 soluble |
0.07 |
0.29 |
1.18 |
0.12 |
0.76 |
0.61 |
0.62 |
2.53 |
2.54 |
CHCL3 insoluble |
0.18 |
0.98 |
0.77 |
0.59 |
1.64 |
0.18 |
0.23 |
0.73 |
0.85 |
Carcass |
|||||||||
CHCl3 soluble |
0.53 |
1.13 |
1.39 |
0.68 |
0.91 |
6.2 |
11.3 |
17.95 |
26.4 |
CHCL3 insoluble |
1.44 |
2.58 |
2.85 |
2.84 |
2.80 |
1.45 |
1.07 |
5.65 |
3.9 |
Total recovery |
2.54 |
5.64 |
6.9 |
5.03 |
6.8 |
10.4 |
15.48 |
32.31 |
40.88 |
Exp. 1, 2, 7-9: test substance administered in water
Exp. 3 -6, 10, 11: test substance administered in corn oil
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.