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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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.
- Qualifier:
- no guideline followed
- Guideline:
- other: no data
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing and feeding:
Temperature: 20°C - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- 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
- 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
- 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. - 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
- Critical effects observed:
- not specified
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- 4 studies with reliability of 2 are available.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Available data:
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.
15 male and 15 female CFE rats were fed diets containing 0, 360, 1180 or 2470 mg/kg bw quillaja extract for males and 0,440, 1370 or 3030 mg/kg bw for females for 13 weeks.
No treatment-related effects on mortality, clinical signd, haematology, clinical chemistry, uirinanalysis gross pathology or histologic pathology were seen.
High-dose males and mid- and high-doese females had statistically significant lower body weight than those of controls. Food and water consumption was decreased in high- and mid-dose rats of both sexes. Liver weights were decreased in males at the 2.0 and 4.0& level, but since this was not correlated with changes in clinical chemistry the effects are considered as not resulting from toxicity of the test material. In addition, no related histopathological abnormalities were observed.
Therefore the No Observed Effect Level was estimated as 2470 mg/kg bw in male and 3030 mg/kg bw female rats.
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.
Groups of 48 male and 48 female mice were fed a diet containing 0, 0.1, 0.5 or 1.5% Quillaja extract for 84 weeks. Abnormal behaviour and condition were observed regularly and the body weight was determined at intervals. After 24, 56 and 84 weeks haematological parameters were measured.
No effects on mortality or clinical signs were observed. The body weights of the high-dose male animals were reduced. No changes in haematology were detected. The detailed autopsy and histopathology revealed no treatment-related abnormalities.
The No Observed Adverse Effect Levels was 700 mg/kg bw.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The published data are reliable with restrictions.
Justification for classification or non-classification
In conclusion, the results of the available data on repeated dose toxicity indicate that Quillaja saponaria ext. does not need to be classified for repeated dose toxicity according to the CLP-Regulation (Regulation 1272/2008/EC) and therefore labelling is not necessary.
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