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EC number: 273-620-4 | CAS number: 68990-67-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Quillaja saponaria, Rosaceae.
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- 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:
- Long-term toxicity of Quillaja extract in rats
- Author:
- J.J.P. Drake et al.
- Year:
- 1 982
- Bibliographic source:
- Food Cosmet. Toxicol., 20, 15-23 (1982)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: no data
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Quillaja saponaria, ext.
- EC Number:
- 273-620-4
- EC Name:
- Quillaja saponaria, ext.
- Cas Number:
- 68990-67-0
- Molecular formula:
- Monomeric saponins range from ca. 1800 to ca. 2300, consistent with a triterpene with 8-10 monosaccharide residues
- IUPAC Name:
- Quillaja saponaria, ext.
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- spray-dried liquid extract of Quillaja bark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing and feeding:
Temperature: 20°C
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.3, 1.0 or 3.0% in the diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- 48 male and 48 female animals
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Body weight: 2-monthly intervals
Food and water consumption: 24-hour period prior to body weight determination
Blood (tail veins): week 15, 25 and 52
Blood (aorta): week 108
Urin: week 13, 24, 78 - Sacrifice and pathology:
- complete autopsy including histological examinations of tissues and organs
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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
- Details on results:
- Body weight: High-dose male female rats weighed 7-8% lower than controls after 106 weeks.
Food consumption: Food consumption was 1-10% lower in all treated groups.
No other treatment related effects were observed.
The incidence of benign tumors and carcinomas of the thyroid, pituitary and peritoneal cavity were not statistically different from controls or fell within the spontaneous incidence rate of the Wistar rat.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Groups of 48 male and 48 female rats were fed a diet containing 0, 0.3, 1.0 or 3.0% Quillaja extract for 108 weeks. Haematological examinations were made at week 15, 25, 52 and 108. Urinanalysis were carried out at week 13, 24 and 78. At sacrifice a complete autopsy including histological examination was performed.
High-dose male female rats weighed 7-8% lower than controls after 106 weeks and food consumption was 1-10% lower in all treated groups.
No other treatment related effects were observed.
The incidence of benign tumors and carcinomas of the thyroid, pituitary and peritoneal cavity were not statistically different from controls or fell within the spontaneous incidence rate of the Wistar rat. The NOAEL was 1175 mg/kg bw for males and 1500 mg/kg bw for females. - Executive summary:
Groups of 48 male and 48 female rats were fed a diet containing 0, 0.3, 1.0 or 3.0% Quillaja extract for 108 weeks. Haematological examinations were made at week 15, 25, 52 and 108. Urinanalysis were carried out at week 13, 24 and 78. At sacrifice a complete autopsy including histological examination was performed. High-dose male female rats weighed 7-8% lower than controls after 106 weeks and food consumption was 1-10% lower in all treated groups. No other treatment related effects were observed. The incidence of benign tumors and carcinomas of the thyroid, pituitary and peritoneal cavity were not statistically different from controls or fell within the spontaneous incidence rate of the Wistar rat. The NOAEL was 1175 mg/kg bw for males and 1500 mg/kg bw for females.
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