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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
The test item was tested for eye irritation by an alternative method (application to fibroblast of rabbit cornea and cytotoxicity assessment by the neutral red release method). The substance has insignificant cytotoxicity.
The product applied as such in a single patch test, can be considered as non-irritant after an application with the help of an occlusive patch for 48 h on 11 volunteers.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-21 January 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- Study performed according to French offical method published in December 1999 in National register N° 302, and Good Laboratory Practice
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix VI of the French National Register N°302 of December, 1999
- Deviations:
- not specified
- Principles of method if other than guideline:
- This test is an alternative method which aims to assess a test item eye irritant potential,. The principle is based on the test item cytotoxicity assessment by determination of the concentration which leads to 50% of cells death (IC50) on a cell monolayer, using the Neutral Red Uptake Method.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Rabbit cornea fibroblasts: SIRC line (ATCC CCL60)
- Details on test animals or tissues and environmental conditions:
- Rabbit cornea fibroblasts: SIRC line (ATCC CCL60)
- Vehicle:
- other: physiological serum or cottonseed oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Dilution at 25% and 50% of the test material are used.
- Duration of treatment / exposure:
- contact with the test item = 60 secondes
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- Not specified
- Number of animals or in vitro replicates:
- Each sample and positive control are tested on three cultures wells by assessed concentration. Negative control is tested on three culture wells per plate.,
- Irritation parameter:
- other: Percentage of mortality observed at the 50% dilution
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Estimated IC 50 (%)
- Value:
- > 50
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Interpretation of results:
- other: insignificant toxicity
- Remarks:
- according to table of French national register N°302, December 1999
- Conclusions:
- The cytotoxicity of tested material is insignificant.
IC 50 is greater to 50% and the percentage of mortality observed at the dilution 50% is 3%.
Under the retained experimental conditions, the cytotoxicity of the tes item may be classified as insignificant cytotoxicity according to the adopted scale - Executive summary:
An in vitro eye irritation study was performed on rabbit cornea fibroblasts according to French national Method published in December 1999 in National register N° 302. The principle of the method is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
Positivie and Negative (vehicle) controls were used.
The IC50 was up to 50% and the percentage of mortality at the dilution 50% was 3%.
According to this method the cytotoxicity is considered as insignificant.
Reference
Substance tested | Dose (%) | mean percent of cells mortality |
SDS | 0.2% | 85 |
SDS | 0.05% | 39 |
SDS | 0.01% | 20 |
test item | 25% | 10 |
test item | 50% | 3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An in vitro eye irritation study was performed, on rabbit cornea fibroblasts, according to French national Method published in December 1999 in National register N° 302.
The principle of the method is based on assessing the cytotoxicity of the product tested by identifying the concentration causing 50% mortality (IC50) using the technique of neutral red release.
The IC50 was up to 50% and the percentage of mortality at the dilution 50% is 3%.
According to the method the cytotoxicity is considered as insignificant.
Skin irritation was assessed by a single patch test, on 11 volunteers (men and women, aged from 18 to 65 years) without any dermatological lesion on the experimental area. 0.02 mL of test item was applied, on the external face of the arm, maintained for 48 hours in contact with the skin, with the help of an occlusive patch (Finn Chamber).
The average irritation index was 0.
Under the conditions employed, in this study, the test item was considered as non irritant for skin.
Justification for classification or non-classification
On a single patch test, performed on 11 volunteers, the product has been demonstrated to be non irritant for skin.
On an in vitro test, based on neutral red release method on rabbit cornea fibroblasts, the test item has been considered to have insignificant cytotoxicity.
Also, considering the composition of the registered substance, mainly composed of proteins from Lupinus Albus seeds, the registered substance does not need to be classified as irritating for eyes and skin under CLP Regulation (1272/2008).
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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