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EC number: 250-097-0 | CAS number: 30233-64-8
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: weight of evidence assessment based on hydrolysis products and structural analogues
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: based on expert group reviews
- Justification for type of information:
- Limited data are available fordocosanoic acid, monoester with glycerol The toxicokinetic properties of docosanoic acid, monoester with glycerol is assessed in the present weight of evidence analysis based on existing data on based on existing data on mono-, di- and triglycerides, fatty acids and glycerol.
The following expert opinions (attached in section 13) will be used in the weight of evidence approach:
CIR 2016: Cosmetic Ingredient Review. Safety assessment of monoglyceryl monoesters as used in cosmetics. Final amended report, January 15, 2016.
EFSA (2017a): Re-evaluation of fatty acids (E 570) as a food additive EFSA Journal 2017;15(5):4785
EFSA (2017b): Re-evaluation of glycerol (E 422) as a food additive EFSA Journal 2017;15(3):4720
EFSA (2017c). Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives EFSA Journal 2017;15(11):5045
OECD SIDS (2014). SIDS INITIAL ASSESSMENT PROFILE. Glycerides category. CoCAM 6, 30 - 03 October 2014 - Principles of method if other than guideline:
- As no specific data on toxicokinetics of docosanoic acid, monoester with glycerol is available, the weight of evidence assessment is based on toxicokinetic data on monoglycerides in general and on glycerol and fatty acids. The data is extracted from expert opinions (attached in section 13)
- GLP compliance:
- not specified
- Remarks:
- Data extracted from expert opinions
- Details on absorption:
- Docosanoic acid, monoester with glycerol (CAS 30233-64-8) is ready absorbed (up to nearly 100%) in the gastrointestinal tract either as the monoester or as glycerol and docosanoic acid.
Glycerol is then subject to phosphorylation and oxidation and is used as an energy substrate via glycolysis or participates in gluconeogenesis and lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only minor amounts excreted via urine or faeces.
Fatty acids are after absorption either metabolised or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids, either incorporated into glycerides and phospholipids, are catabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation. - Details on distribution in tissues:
- Docosanoic acid, monoester with glycerol (CAS 30233-64-8) is ready absorbed (up to nearly 100%) in the gastrointestinal tract either as the monoester or as glycerol and docosanoic acid.
Glycerol is then subject to phosphorylation and oxidation and is used as an energy substrate via glycolysis or participates in gluconeogenesis and lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only minor amounts excreted via urine or faeces.
Fatty acids are after absorption either metabolised or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids, either incorporated into glycerides and phospholipids, are catabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation. - Details on excretion:
- Docosanoic acid, monoester with glycerol (CAS 30233-64-8) is ready absorbed (up to nearly 100%) in the gastrointestinal tract either as the monoester or as glycerol and docosanoic acid.
Glycerol is then subject to phosphorylation and oxidation and is used as an energy substrate via glycolysis or participates in gluconeogenesis and lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only minor amounts excreted via urine or faeces.
Fatty acids are after absorption either metabolised or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids, either incorporated into glycerides and phospholipids, are catabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation. - Details on metabolites:
- Docosanoic acid, monoester with glycerol (CAS 30233-64-8) is ready absorbed (up to nearly 100%) in the gastrointestinal tract either as the monoester or as glycerol and docosanoic acid.
Glycerol is then subject to phosphorylation and oxidation and is used as an energy substrate via glycolysis or participates in gluconeogenesis and lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only minor amounts excreted via urine or faeces.
Fatty acids are after absorption either metabolised or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids, either incorporated into glycerides and phospholipids, are catabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation. - Conclusions:
- As no specific data on toxicokinetics of tocosanoic acid, monoester with glycerol is available the weight of evidence assessment is based on toxicokinetic data on monoglycerides in general and on glycerol and fatty acids. Form these data it can be concluded that docosanoic acid, monoester with glycerol is ready absorbed (up to nearly 100%) in the gastrointestinal tract either as the monoester or as glycerol and docosanoic acid as extensive hydrolysis in the gastrointestinal tract is to be expected.
- Executive summary:
Docosanoic acid, monoester with glycerol (glycerol monobehenate) is a mono
constituent substance with a purity of 80-90%. As no specific data on
toxicokinetics of the substance is available, the assessment is based on
toxicokinetic data on monoglycerides in general and on glycerol and fatty acids.
From these data it can be concluded that docosanoic acid, monoester with
glycerol is ready absorbed (up to nearly 100%) in the gastrointestinal tract
either as the monoester or as glycerol and docosanoic acid as extensive
hydrolysis in the gastrointestinal tract is to be expected.
Glycerol is then subject to phosphorylation and oxidation and is used as an
energy substrate via glycolysis or participates in gluconeogenesis and
lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only
minor amounts excreted via urine or faeces.
Fatty acids are after absorption either metabolised or incorporated into
chylomicrons, which enter the systemic circulation. Ultimately, fatty acids,
either incorporated into glycerides and phospholipids, are catabolised via the boxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is
finally excreted via exhalation.
Data is lacking regarding dermal absorption and a default dermal absorption
ratio of 100% may be assumed.
The available information comprises adequate, reliable studies from reference
substances with similar structure and intrinsic properties. The weight-ofevidence approach is justified based on common functional group and common
precursors/breakdown products. The information from these independent
sources is consistent and provides sufficient weight of evidence leading to an
endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No
1907/2006
Reference
Docosanoic acid, monoester with glycerol is a mono-constituent substance. The main component is docosanoic acid monoester with glycerol, the remaining compounds are mainly fatty acids and monoesters of fatty acid and glycerol. The toxicokinetic properties/fate of this substance is assessed in the present as a weight of evidence analysis based on existing data on mono-, di- and triglycerides, fatty acids and glycerol.
The following was concluded from expert opinions:
According to OECD SIDS (2014) monoglycerides are readily absorbed through the duodenal mucosa and converted to triglycerides. Ingested triglycerides are in the small intestine split by pancreatic lipases into monoglycerides, free fatty acids, and glycerol, which can be absorbed by the intestinal mucosa. A small fraction of triglycerides is absorbed as free glycerol and as diglycerides. Once across the intestinal barrier, triglycerides are reformed.
According to CIR (2016), monoglycerides are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides.
EFSA (2017a) in its opinion on glycerol concluded that glycerol is rapidly and near completely absorbed from the gastrointestinal tract; distributed into the total body water space and is primarily metabolised in the liver. After phosphorylation and oxidation, glycerol is used as an energy substrate via glycolysis or participates in gluconeogenesis and lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only minor amounts excreted via urine or faeces.
EFSA (2017b) in its opinion on fatty acids concluded that caprylic-, capric-, oleic-, lauric-, palmitic-, myristic- or stearic acid like other fatty acids are readily and extensively absorbed from the gastrointestinal tract. After absorption, fatty acids are either metabolised or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids, either incorporated into glycerides and phospholipids, are catabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation.
EFSA (2017c) noted that after exposure in rats to cottonseed oil monoglycerides, only traces were found in the faeces, indicating an oral absorption rate of 97.8±0.4%.
Description of key information
Docosanoic acid, monoester with glycerol (glycerol monobehenate) is a mono constituent substance with a purity of 80-90%. As no specific data on toxicokinetics of the substance is available, the assessment is based on toxicokinetic data on monoglycerides in general and on glycerol and fatty acids. From these data it can be concluded that docosanoic acid, monoester with glycerol is ready absorbed (up to nearly 100%) in the gastrointestinal tract either as the monoester or as glycerol and docosanoic acid as extensive hydrolysis in the gastrointestinal tract is to be expected.
Glycerol is then subject to phosphorylation and oxidation and is used as an energy substrate via glycolysis or participates in gluconeogenesis and lipogenesis. Glycerol is extensively oxidised and exhaled as CO2, with only minor amounts excreted via urine or faeces.
Fatty acids are after absorption either metabolised or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids, either incorporated into glycerides and phospholipids, are catabolised via the b-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation.
Data is lacking regarding dermal absorption and a default dermal absorption ratio of 100% may be assumed.
The available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. The weight-of-evidence approach is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 100
Additional information
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.
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