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Diss Factsheets
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EC number: 266-533-8 | CAS number: 66988-04-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Basic toxicokinetics
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:
- 1 969
- 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
- Reference substance name:
- Reference substance 002
- Cas Number:
- 5793-94-2
Constituent 1
- 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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