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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 90 day study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study closely followed the OECD 408 “Repeat dose 90 day oral toxicity study in rodents” test guidelines & has GLP compliance. However, it does not include any details regarding urine analysis.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Principles of method if other than guideline:
- The study closely followed the OECD 408 “Repeat dose 90 day oral toxicity study in rodents” test guidelines & has GLP compliance. However, it does not include any details regarding urine analysis.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Phytosterol esters
- IUPAC Name:
- Phytosterol esters
- Details on test material:
- Gross composition of the test material as shown below:
Constituent Composition (%w/w)
Total sterol 62.0
Total fatty acid 38.2
Free sterol (as % of the total mixture) 8.4
Free fatty acid <0.3
Sterol profile
Cholesterol (0.4%)
Brassicasterol (1.1%)
Campesterol (25.8%)
Stigmasterol (21.6%)
Beta-sitosterol (48.7%)
Beta-sitostanol (1.8%)
Unknowns (0.8%)
Fatty acid profile
C16:0 (9.6%)
C18:0 (4.1%)
C18:1 (21.6%)
C18:2 (64.6%)
Note, the phytosterols were sourced from a variety of common edible vegetable oil distillates and then re-esterified with fatty acids from sunflower oil.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 7 days/week in diet for 90 days.
- Frequency of treatment:
- 7 days/week in diet for 90 days.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Doses of 0.16, 1.6, 3.2, and 8.1% (w/w) equivalent to phytosterol concentrations of 0.1, 1.0, 2.0, and 5.0 % (w/w) respectively
Basis:
nominal in diet
- No. of animals per sex per dose:
- Male and female (20 of each per group) and one control group and four treatment groups.
- Control animals:
- yes, concurrent no treatment
Results and discussion
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- > 6.6 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Food consumption
No adverse effects noted.
Water consumption
No adverse effects noted.
Clinical signs
None noted that could be attributed to the test compound.
Body weight
No statistically significant differences in mean body weights observed for any treated group compared to the control group.
Organ weights
No statistically significant changes in organ weights in comparison to the control group.
Haematology
Some minor statistically significant changes in some haematology in males and/or females, but none were considered to be of toxicological significance.
Clinical Chemistry
Some minor statistically significant changes in some clinical chemistry in males and/or females, but none were considered to be of toxicological significance.
Urinalysis
No information provided.
Macroscopic examination
No findings noted at necropsy.
Histopathology
None attributed to the test substance.
Applicant's summary and conclusion
- Conclusions:
- The results of this study showed there to be no clinical signs or effects on survival attributed to the administration of the test material. A NOEL of 8.1% (PE) was identified in the study, which is equivalent to a dose of 6.6 g/kg/bw/day PE or 4.1 g phytosterol/kg bw/day.
- Executive summary:
In a published study (Hepburnet al., 1999), phytosterol esters (PE) were added to the diet of male and female Wistar derived rats over a period of 90 days, to give concentrations of 0.16, 1.6, 3.2, and 8.1% (w/w) equivalent to phytosterol concentrations of 0.1, 1.0, 2.0, and 5.0 % (w/w) respectively. (Similar to OECD 408 test guideline, Rel. 2)
The results of this study showed there to be no clinical signs or effects on survival attributed to the administration of the test material. A NOEL of > 8.1% (PE) was identified in the study, which is equivalent to a dose of 6.6 g/kg/bw/day PE or 4.1 g phytosterol/kg bw/day.
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.