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Diss Factsheets
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EC number: 619-079-3 | CAS number: 949109-75-5
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 540 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Reliability 2
NOAEL > 1540 mg/kg bw/day (expressed as phytosterol)
Additional information
In a well conducted OECD 416 oral feeding study in rats (with some deviations from the test guideline) a nominal dietary PE concentration of > 8.1% (equivalent to a dose of 2.5 -9.1 g Phytosterol Esters/kg body weight/day or 1.54 – 5.62 g phytosterol/kg/body weight/day, dependent on the phase of the study) was considered to be the no observed adverse effect level in this study. (1540 mg/kg bw/day expressed as phytosterol is the lowest value in the range that was given in the report and is taken as the NOAEL for this study). It should be noted that there were no treatment related effects on reproduction, on the development of the offspring, or on sexual maturation.
Short description of key information:
In a well conducted OECD 416 oral feeding study in rats (with some deviations from the test guideline) a nominal dietary Phytosterol Esters concentration of > 8.1% (equivalent to a dose of 2.5 -9.1 g Phytosterol Esters/kg body weight/day or 1.54 – 5.62 g phytosterol/kg/body weight/day, dependent on the phase of the study) was considered to be the no observed adverse effect level in this study.There were no effects on reproduction, on the development of the offspring, or on sexual maturation.
Justification for selection of Effect on fertility via oral route:
Well conducted OECD 416 oral feeding study in rats.
Effects on developmental toxicity
Description of key information
No adverse treatment-related maternal or foetal developmental effects were produced following ingestion of a diet containing up to 8.76% plant stanol fatty acid esters. This diet provided up to 5% of total dietary stanols equivalent to 2.4-3.5 g stanols/kg bw/day depending on the (days 0 -7: 3.5 g total stanols/kg bw/day, days 7 -14: 3.6 g total stanols/kg/bw/day, days 14 -21: 2.4g total stanols/kg/bw/day)
No significant differences were seen in reproductive performance, maternal and foetal body weights, sex distribution, or visceral or skeletal malformations, anomalies, and variations. Vegetable oil-derived stanol fatty acid esters are concluded not to be developmental toxicants and did not produce any embryotoxic, foetotoxic, or teratogenic effects in Wistar rats under the conditions of the study.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 400 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Reliability 1
NOAEL > 2400 mg/kg bw/day (expressed as stanols)
Additional information
In a well conducted OECD 414 compliant study, no adverse treatment-related maternal or foetal developmental effects were produced following ingestion of a diet containing up to 8.76% plant stanol fatty acid esters. This diet provided up to 5% of total dietary stanols equivalent to 2.4-3.5 g stanols/kg bw/day depending on the (days 0 -7: 3.5 g total stanols/kg bw/day, days 7 -14: 3.6 g total stanols/kg/bw/day, days 14 -21: 2.4g total stanols/kg/bw/day)
No significant differences were seen in reproductive performance, maternal and foetal body weights, sex distribution, or visceral or skeletal malformations, anomalies, and variations. Vegetable oil-derived stanol fatty acid esters are concluded not to be developmental toxicants and did not produce any embryotoxic, foetotoxic, or teratogenic effects in Wistar rats under the conditions of the study. NAOEL is set as being greater than 2400 mg total stanols/kg (bw)
Justification for selection of Effect on developmental toxicity: via oral route:
A well conducted (rel 1) OECD 414 study in rats.
Justification for classification or non-classification
On the basis of the results of two well conducted reproductive toxicity and developmental toxicity studies in rats where no treatment related effects were observed, no classification will be required under the Dangerous Substances Directive (67/548/EEC) and CLP Regulation (1207/2008).
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.
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.