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EC number: 232-462-6 | CAS number: 8047-15-2
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The published data are considered as reliable with restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Short-term toxicity of Quillaja extracts in rats
- Author:
- I.F. Gaunt et al.
- Year:
- 1 974
- Bibliographic source:
- Food Cosmet.Toxicol. , 12, 641-650 (1974)
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:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Saponins
- EC Number:
- 232-462-6
- EC Name:
- Saponins
- Cas Number:
- 8047-15-2
- Molecular formula:
- not applicable UVCB
- IUPAC Name:
- Saponin
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- spray-dried aqueous extract of quillaja bark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFE strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
Body weight: 130 - 170 g
Housing and feeding:
Temperature: 20°C
Humidity: 40 - 50%
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.6, 2, 4 %
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15 male and 15 female rats were fed diets containing 0, 0.6, 2 or 4% quillaja extract for 13 weeks. 5 male and 5 female rats received 0, 2, 4 quillaja extract for 2 or 6 weeks.
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Body weight and food intake were measured at the beginning and weekly throughout the study.
Urine was analysed during the final week. - Sacrifice and pathology:
- At sacrifice, the absolute and relative organ weights were determined. Tissues and organs of the group given 4% quillaja were examined by histopathology. Blood collected at autopsy was examined for haematological and serum chemical parameters.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a repeated dose study 15 male and 15 female CFE rats were fed diets containing 0, 0.6, 2 and 4% quillaja extract for 13 weeks. No abnormalities of behaviour or condition were seen. Bodyweight gain was reduced in the group receiving 4%. Food and water consumption were reduced in animals of each sex at all dietary levels but at the end of the study the weights of treated rats did not differ significantly from those of the controls.The relative liver weights of male rats given 2 or 4% quillaja was reduced and the stomach weight was increased in both sex at the same dose levels.
No effects on haematological parameters and clinical were noted.
Histopathology revealed no abnormal changes. Therefore the No Observed Effect Level was estimated as 400 mg/kg in male and female rats. - Executive summary:
In a repeated dose study 15 male and 15 female CFE rats were fed diets containing 0, 0.6, 2 and 4% quillaja extract for 13 weeks. No abnormalities of behaviour or condition were seen. Bodyweight gain was reduced in the group receiving 4%. Food and water consumption were reduced in animals of each sex at all dietary levels but at the end of the study the weights of treated rats did not differ significantly from those of the controls.The relative liver weights of male rats given 2 or 4% quillaja was reduced and the stomach weight was increased in both sex at the same dose levels.
No effects on haematological parameters and clinical were noted.
Histopathology revealed no abnormal changes. Therefore the No Observed Effect Level was estimated as 400 mg/kg in male and female rats.
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