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EC number: 293-170-2 | CAS number: 91052-13-0
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: GRAS notification
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA - Generally recognized as safe (GRAS) notification on Glycerin and Glycerides
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
Results and discussion
Any other information on results incl. tables
Select Committee on GRAS Substances Opinion:
1. Mono- and diglycerides of edible fat-forming fatty acids
Although mono- and diglycerides of edible fat-forming fatty acids are found naturally, those that are used as food additives are usually prepared synthetically. Mono-, di- and triglycerides are metabolized by the same mechanisms. The biological effects of glycerides are either those of the entire molecule or of the metabolic products, fatty acids and glycerin. Triglyceride fats are a major source of calories in the diet of many people. Mono- and diglycerides are minor components of natural fats. They are intermediate metabolic products of ingested triglycerides. There is no evidence that the mono- and diglycerides of edible fat-forming fatty acids behave differently from triglycerides upon ingestion. There is evidence that ingestion of excesses of saturated fats and cholesterol promotes arteriosclerosis and cardiovascular disease. Continuation of research in this area may refine relationships of the various fatty acids to the point where harmfulness may become an impelling consideration. However, because a reasonable estimate of the consumption of all added mono- and diglycerides is of the order of 1 to 10 g per person per day, only a fraction of which contains saturated fatty acids, it can hardly be concluded that they make a sufficient contribution to any hazard associated with normal ingestion of saturated fatty acids in fatty foods to justify limitation of the level of their current use. In light of the scientific information available, the Select Committee concludes that: There is no evidence in the available information on mono- and diglycerides of fat-formaing fatty acids that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.
2. Diacetyl tartaric acid esters of mono- and diglycerides
The diacetyl tartaric acid esters of mixed mono- and diglycerides have been found to be without toxic effects in long-term feeding experiments with rats and dogs at levels that were orders of magnitude greater than those to which consumers are exposed. In light of these data, the Select Committee concludes that: There is no evidence in the available information on the diacetyl tartaric acid esters of mono- and diglycerdies that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.
3. Triacetin, acettooleins, acetostearins
Triacetin and two types of acetooleins have been found to be without toxic effects in long-term feeding tests in rats at levels that were several orders of magnitude greater than those to which consumers are exposed. Three types of acetostearins have been found to be without toxic effects in long-term feeding tests in rats at levels up to 5 g per kg per day. This contrasts with an estimated human consumption of a fraction of a milligram per kg per day. It is recognized that at an even higher feeding level (10 g per kg per day) male rats developed testicular atrophy and female rats, uterine discoloration. However, such a level which would amount to 50 g or more for an infant and 600 g for an adult per day, is vastly higher than would be possible in the consumption of foods to which acetostearins are added for functional purposes. In light of the available scientific information the Select Committee concludes that: There is no evidence in the available information on triacetin, acetooleins, and acetostearins that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.
4. Glyceryl lactopalmitate, glyceryl lactooleate
Glyceryl lactopalmitate, glyceryl lactooleatehave been found to be without toxic effects in long-term feeding tests with rats at levels that were orders of magnitude greater than those to which consumers are exposed. In light of the available scientific information the Select Committee concludes that: There is no evidence in the available information on glyceryl lactopalmitate and glyceryl lactooleate that demonstrates or suggests reasonable grounds to suspect a hazard to the pulbic when they are used at levels that are now current or that might reasonably be expected in the future.
5. Oxystearins
In the only chronic study of the oxystearins available to the Select Committee, levels as high as 7.5 g per kg per day for two years elicited no chronic toxic effects. However, Leydig cell adenomas of the testes were observed. It is recognized that the investigators noted that it was only remotely possible that appearance of these adenomas was related to the oxystearins in the diet and that the dietary level at which they appeared was several orders of magnitude greater than could occur practically. Nevertheless, until this effect has been adequately explained it is inappropriate to conclude that unrestricted use of oxystearins in food would be without hazard. The Select Committee also recognizes the need for establishing the identity of the substances now referred to as the "oxystearins" since the oxidative processes by which they now are prepared would be expected to produce a number of products, such as peroxides, of varying nature and amount. In light of the scientific information available, the Select Committee concludes that: While no evidence in the available information on oxystearins demonstrates a hazard to the public when they are used at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies should be conducted.
6. Other glycerides
Opinions and conclusions concerning the sulfoacetate derivatives of mono- and diglycerides, the monosodium phosphate derivatives of mono- and diglycerides and monoglyceride citrate cannot be provided due to the absence or inadequacy of biological data. While chronic feeding studies of a product called succistearin revealed no evidence of toxic effects at levels that were orders of magnitude greater than those to which consumers are exposed, the product fed was a mixture whose primary constituent (stearoyl propylene glycol hydrogen succinate) is not a glyceride. Therefore, a conclusion with respect to succistearin is not included in this report.
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.
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