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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to current OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Stanol fatty acid esters
- IUPAC Name:
- Stanol fatty acid esters
- Details on test material:
- The sample identified as Sito – 70 stanol ester contained 57.08% total stanols/100g fat (68% sitostanol, 30% campestanol, 2% unsaturated sterol), 41.96% fatty acids and 2% unsaturated sterols and unknowns.
Approximately 93.4% of the esterified groups was C-18 fatty acids, with 3.6% C-16, 2.1% C-20 and 0.9% other fatty acid esters.
Note: Rapeseed oil was used to top-up the diets in the developmental toxicity study. Although the literature reports sterol concentrations in the order of a few hundred mg/100 g, this is unlikely to negate the validity of the study, since there were no findings of adverse effects on developmental parameters.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- From day 0 to 21 of gestation. The diets contained 0, 1, 2 or 5% total stanols (corresponding to 0, 1.75, 4.38 and 8.76% of the stanol ester test material).
- Frequency of treatment:
- From day 0 to 21 of gestation, daily
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
The diets contained 0, 1, 2 or 5% total stanols (corresponding to 0, 1.75, 4.38 and 8.76% of the stanol ester test material).
Basis:
nominal in diet
- No. of animals per sex per dose:
- 28 mated females
- Control animals:
- yes, concurrent no treatment
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 400 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Food consumption
The effect of PE on the food consumption was inconsistent, but significantly different compared to the control group; both increasing and decreasing during different phases of the study.
Water consumption
No information.
Clinical signs
None noted that could be attributed to the test compound.
Effects on developmental performance
None noted that could be attributed to the test compound.
Body weight
Body weight gains were not significantly different from control values for any group throughout gestation except for a small but statistically significant decrease at days 0 -7 for the high dose group. This is believed to be due to a decrease in calorific content of the diet from the levels of unabsorbable stanols at the highest dose.
Organ weights
No statistically significant changes in organ weights in comparison to the control group.
Haematology
No specific information provided.
Clinical Chemistry
No specific information provided.
Urinalysis
No specific information provided.
Macroscopic examination
No findings noted at necropsy.
Histopathology
No specific information provided.
Applicant's summary and conclusion
- Conclusions:
- The test sample was given in the diet of rats (SPF Wistar) from day 0 to 21 of gestation after which time they were sacrificed and examined. The diets contained 0, 1, 2 or 5% total stanols (corresponding to 0, 1.75, 4.38 and 8.76% of the stanol ester test material). 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.
- Executive summary:
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.
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