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EC number: 215-354-3 | CAS number: 1323-39-3
- 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
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 for Stearic acid, monoester with propane-1,2-diol (PGMS). The toxicokinetic properties of PGMS is assessed in the present weight of evidence analysis based on existing data on PGMS and the relevant hydrolysis products: propane-1,2-diol (EFSA 2018b), fatty acids in general and fatty acid salts (EFSA 2017 and CIR 2019).
In general, data on propane-1,2-diol esters of fatty acids (EFSA 2018a), fatty acids (EFSA 2017) and fatty acids and salts of fatty acids (CIR 2019) and propane-1,2-diol (EFSA 2018b) will be used in the weight of evidence approach:
CIR (2015): Cosmetic Ingredient Review. Safety assessment of propylene glycol esters as used in cosmetics. Final amended report, 2015.
CIR (2019): Cosmetic Ingredient Review. Safety assessment of fatty acids & fatty acids salts as used in cosmetics. Tentative report for public comment, January 4, 2019.
EFSA (2017). Re-evaluation of fatty acids (E 570) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(5):4785
EFSA (2018a). Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive, EFSA Journal 2018; 16 (12), Scientific Opinion Adopted 7 November 2018.
EFSA (2018b). Re-evaluation of propane-1,2-diol (E 1520) as a food additive, EFSA Journal 2018; 16 (4), Scientific Opinion Adopted 13 March 2018. - Details on absorption:
- Stearic acid, monoester with propane-1,2-diol is hydrolysed by pancreatic lipase in the intestine and is readily absorbed.
- Details on distribution in tissues:
- The main products by hydrolysis of Stearic acid, monoester with propane-1,2-diol is propane-1,2-diol and stearic acid. Propane-1,2-diol is readily absorbed from the gastrointestinal tract and systemically distributed and primarily metabolised in the liver.
- Details on excretion:
- Stearic acid, monoester with propane-1,2-diol is excreted in the urine and feces, however, a significant proportion is utilized and excreted as CO2
- Details on metabolites:
- The main products by hydrolysis of PGMS is propane-1,2-diol and stearic acid.
Propane-1,2-diol is readily absorbed from the gastrointestinal tract and is expected to be widely distributed to organs and tissues (EFSA 2018b). Propane-1,2-diol is primarily metabolized via oxidation to lactic acid and pyruvic acid.
After absorption from the gastrointestinal tract, fatty acids (e.g. stearic acid) are either metabolized or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids are either incorporated into triglycerides and phospholipids and stored or catabolized via the beta-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation. - Conclusions:
- Based on the studies available for Stearic acid, monoester with propane-1,2-diol , the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the compoundStearic acid, monoester with propane-1,2-diol is partially hydrolysed e.g. by pancreatic lipase into propane-1,2-diol and stearic acid. These substances are then readily absorbed from the intestine, systemically distributed and primarily metabolised in the liver or used as precursors in biogenesis similar to those obtained from intake of a regular diet
- Executive summary:
Limited data are available on the toxicokinetics of the UVCB substance, Stearic acid, monoester with propane-1,2-diol (PGMS). However, several data exists on the toxicokinetics of the hydrolytic products: propane-1,2-diol (E 1520) and certain fatty acids (E 570). The overall conclusion of the toxicokinetics of PGMS is, that in the gastrointestinal tract the substance is partially hydrolysed e.g. by pancreatic lipase into propane-1,2-diol and stearic acid. These substances are then readily absorbed from the intestine, systemically distributed and primarily metabolised in the liver or used as precursors in biogenesis similar to those obtained from intake of a regular diet.
Reference
Description of key information
Limited data are available on the toxicokinetics of the UVCB substance, Stearic acid, monoester with propane-1,2-diol (PGMS). However, several data exists on the toxicokinetics of the hydrolytic products: propane-1,2-diol (E 1520) and certain fatty acids (E 570), that are included in the assesment. The overall conclusion of the toxicokinetics of PGMS is, that in the gastrointestinal tract the substance is partially hydrolysed e.g. by pancreatic lipase into propane-1,2-diol and stearic acid. These substances are then readily absorbed from the intestine, systemically distributed and primarily metabolised in the liver or used as precursors in biogenesis similar to those obtained from intake of a regular diet.
Based on the available data the total oral absorption rate is overall considered to be 100% in relation to parent substance and hydrolysis products.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
Additional information
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