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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: The acute oral toxicity of the liquid QUILLAJA EXTRACT QL AGRI, LOTE: 260208-0700 was investigated according to US EPA Guideline EPA OPPTS 870.1100. A group of 3 female Sprague Dawley rats were administered a liquid extract of Quillaja saponaria at a single dose of 5000 mg/kg bw by gavage.
No mortality and no clinical signs of toxicity were obeserved. No abnormalities were recorded durcing necropsies. Therefore the acute oral LD50 value was estimated as > 5000 mg/kg bw.
Acute toxicity by the inhalation route: The acute toxicity by the the inhalation route of Quillaja saponaria powder was examined according to OECD Guideline 403. A limit test with an exposition of 0.45 mg/L as a nominal concentration was performed due to the physical-chemical properties of the test substance. This was the highest technical achievable concentration. A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. No mortality and clinical sign of toxicity were observed. No abnormalities were recorded during necropsy. Therefore the acute LC50 value of Quillaja saponaria powder can be stated as > 0.45 mg/l.
Acute dermal toxicity: The acute dermal toxicity of a liquid Quillaja saponaria extract was investigated according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal Toxicity).
The test item was applied as a single dose of 2000 mg/kg bw to the shaved dorsal area of the trunk of 5 male and 5 female Sprague Dawley rats. The coverage of the exposed area was removed after 24 hours. No mortolatity or clinical signs of toxicity was observed. No abnormalites were recorded durcing necropsy. Therefore the acute dermal LD50 was estimated as > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- One reliable study is available.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 450 mg/m³ air
- Quality of whole database:
- One reliable study is available.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- One reliable study is available.
Additional information
No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.
Justification for selection of acute toxicity – oral endpoint
The available study is GLP-compliant and therefore considered reliable without restrictions.
Justification for selection of acute toxicity – inhalation endpoint
The available study is GLP-compliant and therefore considered reliable without restrictions.
Justification for selection of acute toxicity – dermal endpoint
The available study is GLP-compliant and therefore considered reliable without restrictions.
Justification for classification or non-classification
Acute oral toxicity:
The respective criteria are not met.
The estimated LD50 of > 5000 mg/kg bw. is well above the treshold for hazard category 4 (2000 mg/kg bw). Quillaja saponaria ext. is therefore not classified for acute oral toxicity.
Acute toxicity via the the inhalation route:
The respective criteria are met. The estimated LC50 of > 0.45 mg/l as highest technical achievable concentration does not justify the classification of the test item.
Acute dermal toxicity:
The respective criteria are not met.
The estimated LD50 of > 2000 mg/kg bw. is above the treshold for hazard category 4 (2000 mg/kg bw). Quillaja saponaria ext. is therefore not classified for acute dermal toxicity.
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.
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