Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 282-001-8 | CAS number: 84082-55-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lupinus albus, Leguminosae.
- 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
In an OECD guideline 423 study on rats, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- No data about test item composition
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier (53940 Le genest St Isle FRANCE)
- Females nulliparous and non-pregnant
- Age at study initiation: about 7 weeks
- Weight at study initiation: 210.2g - 220.0g
- Housing: Animals were housed by group of three in solid bottomed clear polycarbonate cages with stain less steel mesh lid.
- Diet (e.g. ad libitum): Foodstuff (A04-10), ad libitum
- Water (e.g. ad libitum): Acidified, tap water (pH 2.5) (wtaer samples analyzed every 6 months for physico-chemical and bacteriological analysis)
- Acclimation period: 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° C ± 2° C,
- Humidity (%): from 50 ± 20%,
- Air changes (per hr): at least 10 cycles per hour
- Photoperiod : (12 hrs day / 12 hrs darkness). - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- In the first step of the study, the test item was administrated by gavage under a volume of 2 mL/kg body weight (corresponding to 2000 mg/kg bw, according to study report).
- Doses:
- 2 mL/ kg bw
- No. of animals per sex per dose:
- 3 (females only)
- Control animals:
- no
- Details on study design:
- The animals were observed regularly on the day of administration (immediately, within 30 minutes after gavage, 1h, 2h, 3h and 4h after administration) and then at least once a day for at least 14 days.
Immediately after administration of the test item, attention was drawn to the signs of choking: in the event of death, the dead animals were immediately autopsied and it was verified that death was due to the toxicity of the test item and not to a track error.
The various parameters observed were: spontaneous activity, Preyer reflex, respiratory effect, convulsions, trembling, temperature, muscle tone, grip strength, palpebral ptosis, mydriasis, salivation, lacrimation, reversal reflex, piloerection, diarrhea, lethargy, Coma, changes in skin, coat, eyes, mucous membranes and mortality.
Animals were weighed on D-1 (day before the administration) and just before administering the test item, then on D4, D8 and D15 (equivalent to 3,7 an 14 days after the test item administration).
On D14, the animals were euthanized by intraperitoneal injection of sodium pentobarbital 6%, at a rate of 1.16 mL/ kg and bleeding at the femoral artery.
They were autopsied and the main organs were observed macroscopically. - Statistics:
- None
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- Slight piloerection was observed on treatment day.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was not classifÌed based on a LD50 higher than 2000 mg/kg bw and no significant toxic effects observed at that dose level.
- Executive summary:
The test item IN 04 was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423.
No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.
The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route in the rat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP study according to OECD 423 guideline
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test item IN 04 was administered to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the OECD Test Guideline No. 423.
No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.
The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route in the rat.
Justification for classification or non-classification
In an OECD guideline 423 study performed on IN04 (mixture containing 18-25% Lupinus albus seed extract), the LD50 is higher than 2000 mg/kg body weight by oral route in the rat. In addition, the registered substance is mainly composed of proteins from Lupinus Albus, therefore no or very low acute toxicity, that should lead to classification of the substance for acute oral toxicity is anticipated.Thus no classification is required for the registered substance according to CLP Regulation (1272/2008(CE)).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.