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EC number: 236-942-6 | CAS number: 13557-75-0
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1969-01-14 to 1969-05-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: In vivo metabolism study in rats to determine the distribution of 14C activity in rat tissues and excreta following oral administration of sodium capryl lactylate-14C
- Short description of test conditions: A single dose of sodium capryl lactylate-14C was administered by stomach tube to each of four male albino rats at the rate of 250 mg/kg. These animals had received unlabeled sodium capryl lactylate at the same dose rate daily for three days prior to the administration of the tagged material.
- Parameters analysed / observed: Selected tissues, urine, feces and expired CO2 were analysed for radioactivity - GLP compliance:
- not specified
Test material
- Reference substance name:
- Decanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt
- Cas Number:
- 13557-74-9
- IUPAC Name:
- Decanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
(sodium capryl lactylate-14C)
- Source and lot/batch No.of test material: C.j. Patterson Company
RADIOLABELLING INFORMATION (if applicable)
- A primary standard was made by dissolving 11.2 mg of the compound in 10 mL methyl alcohol. The specific activity, as determined in this test system, was found to be 401.464 cpm/mg, which, after correction for 78% instrument efficiency, yields a value of 514.697 dpm/mg or 0.232 µc/mg.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The dose formulation was prepared by suspending 0.5150 g sodium capryl lactylate-14C in 19.5 mL distilled H2O
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Housing: Animals were housed in standard wire mesh cages. After receiving the last dose of unlabeled compound, four rats were individually placed onto modified Roth all-glass metabolism cages and conditioned for 24 hours prior to administration of the tagged material.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: two weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: A primary standard was made by dissolving 11.2 mg of the compound in 10 mL methyl alcohol. The specific activity, as determined in this test system, was found to be 401,464 cpm/mg, which, after correction for 78% instrument efficiency, yields a value of 514,697 dpm/mg or 0.232 uc/mg. The dose formulation was prepared by suspending 0.5150 g sodium capryl lactylate in 19.5 mL distilled H2O.
- Duration and frequency of treatment / exposure:
- Unlabeled compound: once per day for three days
Labeled compound: single treatment
Doses / concentrations
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on study design:
- - Rationale for animal assignment (if not random): After receiving the last dose of unlabelled compound, four rats were individually placed into modified Roth all-glass metabolism cages and condition for 24 hours prior to administration of the tagged material. Selection was based on general performance during the acclimation period, such as body-weight gain, food consumption, and appearance.
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, tissues, gastrointestinal tract contents, CO2.
- Time and frequency of sampling: Two animals were sacrificed 24 hours after dosing, and the remaining two at 48 hours. Thus, the entire experimental period lasted 48 hours. During this period, samples were collected at 8-hour intervals.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- Between the four rats, the range of metabolism into carbon dioxide was 68.98-71.23%
- Type:
- excretion
- Results:
- Between the four rats, the range of dose cleared through urine was 18.62-23.88%
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The compound is almost completely absorbed, and approximately 20% of the dose is cleared through the urine. Very little of the radioactivity was excreted in the feces or retained in the gastrointestinal tract contents.
The compound is rapidly metabolized, the major portion of the dose being converted to CO2 , primarily within 24 hours after administration.
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
Approximately 16 hours after dosing, one rat died. An autopsy was performed which revealed severe necrosis of the stomach. This condition was also found in the other three experimental animals at sacrifice and was especially prominent in another rat. In these animals there was extensive ulceration and is some areas the stomach wall was almost perforated. Although the death of this rat could not be definitely attributed to this condition, it is evident that sodium capryl lactylate at the concentration used caused tissue damage in all animals, and apparently exerts an irritant effect similar to that of a caustic alkali.
Percent of compound that is metabolized and converted into CO2is below.
Hours |
Rat No. 1 |
Rat No. 2 |
Rat No. 3 |
Rat No. 7 |
8 |
51.23 % |
66.86 % |
63.93% |
92.37% |
16 |
16.70% |
2.10% |
5.05% |
7.05% |
24 hours |
1.44% |
0.74% |
|
1.81% |
24-hour total |
69.37% |
69.70% |
68.98% |
71.23% |
Percent of compound that is absorbed and cleared through the urine.
Hours |
Rat No. 1 |
Rat No. 2 |
Rat No. 3 |
Rat No. 7 |
8 |
10.18% |
17.41% |
21.76% |
16.26% |
16 |
9.18% |
1.57% |
2.12% |
2.13% |
24 |
0.33% |
0.11% |
|
0.23% |
24-hour total |
19.69% |
19.09% |
23.88% |
18.62% |
The total recovery of the administered dose amounted to 94.4% for rat No. 1; 94.0% for rat No. 2; 97.0% for rat No. 3 and 93.1% for rat No. 7.
Applicant's summary and conclusion
- Conclusions:
- Sodium capryl lactylate after oral exposure is almost completely absorbed and rapidly metabolised in the rat with the major portion of the dose being converted to CO2 primarily within 24 hours after administration. The recovery of the administered dose (radioactivity) for the 4 rats at 48 hours after dosing ranged from 93 to 97%.
- Executive summary:
A single dose of sodium capryl lactylate-14C was administered by stomach tube to each of four male albino rats at the rate of 250 mg/kg. These animals had received unlabelled sodium capryl lactylate at the same dose rate daily for three days prior to the administration of the tagged material. Samples of urine, faeces and expired CO2, collected periodically from each rat until sacrifice, and selected tissues obtained at necropsy were analysed for radioactivity.
Sodium capryl lactylate after oral exposure is almost completely absorbed and rapidly metabolised in the rat with the major portion of the dose being converted to CO2 primarily within 24 hours after administration. The major portions of the radioactivity were recovered in the CO2 and urine, primarily within 8 hours after dosing. The recovery of the administered dose (radioactivity) for the 4 rats at 48 hours after dosing ranged from 93 to 97%.
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