Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-911-3 | CAS number: 68920-03-6 A complex combination obtained by steam distillation of C16-18 and C18-unsatd. glycerides followed by condensation of the steam.
- 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
Description of key information
Oral NOAEL for risk assessment purposes: 19% in feed, equivalent to an estimated 9,250 mg/kg bw/day for fatty acids and gylcerides and ADI 0.15- 2.0 mg/kd/day for unsaponifiable matter. The dermal toxicology is based on the oral NOAEL.
No significant respiratory exposure.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 9 250 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Justification for classification or non-classification
There is no published information on the repeated dose oral toxicity of 'glycerides C16-18 and C18-unsatd., deodorizer distillates' in animals. However, a large number of studies have been conducted on the individual constituents, particularly in the context of nutritional research. For practical reasons, only a limited number of studies are reported here.
At doses ranging from 7.5 to 19% in diet, no significant toxicity was seen for various glycerides and fatty acids with chain lengths varying between C16-18 or C8-18, including C18-unsatd. and C18-unsatd. hydroxy (Morin, 1967; Harkins and Sarrett, 1968; Nolen, 1981; Manorama and Rukmini, 1991; Coquet et al., 1977; Speijers et al., 2009; Irwin, 1992; HERA, 2002). The most appropriate oral NOAEL (soybean oil) could therefore be considered to be 19% in diet, i.e. ca. 9,250 mg/kg bw/day. In certain studies (also others not reported here), differences may be observed compared to controls on bodyweight gain, food consumption and certain measured parameters depending on the chain length distribution of the fatty acids (associated to the glycerides or free) and their degree of unsaturation. However, research indicates that when consumed at nutritionally relevant concentrations, there are no adverse effects on health and longevity. It is worth noting that, due to their innocuous nature, fats and oils are commonly used as controls and as vehicles in animal toxicity studies. For example, OECD Guideline 408 (repeated dose 90-day oral toxicity study in rodents) recommends the use of “a solution/emulsion in oil (e.g. corn oil)” as a vehicle where an aqueous vehicle is not suitable (OECD, 1993). Several fatty acids (stearic acid; oleic acid and sodium palmitate) are Generally Recognised as Safe (GRAS) by the U.S. Food and Drug Administration (US FDA). Also, fatty acids as a group are permitted as direct food additives (HERA, 2002).
Tocopherols have been tested in numerous repeated dose oral toxicity studies. Overall, animals appear to tolerate high levels (i.e. at least two orders of magnitude above nutritional Vitamin E levels, e.g. 1,000 - 2,000 IU/kg diet) without adverse effects. At very high doses, signs indicative of antagonism with the function of other fat-soluble vitamins, for example impaired bone mineralisation, reduced hepatic storage of Vitamin A and coagulopathies, occur (Tomassi and Silano, 1986; Fiume, 2002; EFSA, 2008). These can be counterbalanced by increasing intake of the other vitamins. A NOAEL of 125 mg/kg bw/day was reported for a 64 week feeding study in rat with tocopheryl acetate.
In animal studies, sterols and sterol esters demonstrate low repeated dose oral toxicity (ANZFA, 2001). The lowest NOAEL in a long term study was equivalent to ca. 2,500 mg sterols/kg bw/day in a 22 month trial with rats (SCF, 2003).
No data could be located on the repeated dose oral toxicity of squalene. This substance is however poorly absorbed through the gastrointestinal tract, therefore repeated dose toxicity is not expected under normal and foreseeable use conditions.
Repeated dose oral, inhalation or dermal exposure to glycerides or fatty acids is not expected to pose an issue for human health under normal and foreseeable handling and use conditions.
The Joint FAO/WHO Expert Committeee on Food Additives (JECFA, 1987) established an Acceptable Daily Intake (ADI) of 0.15 - 2.0 mg/kg bw for dl-a-tocopherol on the basis of clinical experience in man and the fact thata-tocopherol may be an essential nutrient. The EU Scientific Committee on Food set a tolerable upper intake level of Vitamin E for adults of 300 mg a-tocopherol equivalents /day (EFSA, 2008).
Exposure via the inhalation route is not expected given the low vapour pressure of the substance and the risk management measures implemented, where necessary, if the substance is used in aerosilized or spray form.
Based on the above information, the substance is not considered to qualify for repeated dose toxicity classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.