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EC number: 305-224-5 | CAS number: 94350-05-7 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of rice bran composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Cf the attached Read across argumentation
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: highest tested concentration
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: highest tested concentration
- Details on results:
- - No immobilization was observed at 24 h and 48 h (including controls).
- No sign of stress was observed on the mobile daphnids after 48 h of exposure - Results with reference substance (positive control):
- The last toxic response obtained on the reference item K2Cr2O7 (March 24, 2016) gives an EC50-24h of 1.58 mg/L (1.44 – 1.76), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6–2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory
- Validity criteria fulfilled:
- yes
- Conclusions:
- The results obtained for the reference substance on the toxicological endpoint “immobilisation” give an EC50-24h and an EC50-48h higher than the highest tested concentration, i.e. 100 mg/L, based on nominal test item concentration
- Executive summary:
Based on the consideration above, it can be concluded that the results of the study made on Daphnia magna, acute immobilization test performed on the reference substance Proteins hydrolyzates of Lupin (Lupinus Albus)” is likely to predict the properties of the target substance “Proteins hydrolyzates of Rice (Oryza Sativa)” and are considered as adequate to fulfil the information requirement of the Annex VII 9.1.1: 1. Short term toxicity to aquatic invertebrates.
=> EC50-24h and EC50-48h > 100 mg/L (highest tested concentration)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lupine, L. albus, ext.
- EC Number:
- 282-001-8
- EC Name:
- Lupine, L. albus, ext.
- Cas Number:
- 84082-55-3
- IUPAC Name:
- Enzymatic hydrolysis products of Lupinus Albus, Fabaceae, seed
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Yellow powder
- Storage In darkness at room temperature
- Batch: 15 288
- Manufacturing date: October 2015
- Expiry date: October 2017
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- In order to verify the initial concentrations and maintenance of the exposure concentrations of the test item during the exposure period, chemical analysis of the "ANAGELINE AT" in daphnids test solutions were performed at the beginning and after 24 h (before renewal). Method for the chemical analysis of Total Carbon (TC) in samples containing the test item ANAGELINE AT from daphnids ecotoxicology solutions by Total Organic Carbon Analyzer (described in the study 15/1256F/a) and the following protocol:
- in fresh solutions at the beginning of the test (T=0h)
- in old solutions (T=24h)
- for the control (i.e. daphnids test medium filtered) and concentration 100 mg/L
Schedule analysis at initial time:
-Filtered control Abiotic: 1 replicate
-100 mg/L Abiotic: 2 replicates
These solutions were analysed taken directly from the starting solutions without daphnids.
Schedule analysis at final time (before renewal: 24h):
-Filtered control Biotic: 1 replicate
-100 mg/L Biotic: 2 replicates
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test item is soluble and directly dispersed in test medium. The test medium and the solution (100 mg test item/L) were filtered through a membrane filter (cellulose acetate) with a mesh size of 0.22 um to sterilizing and all the manipulations were done under sterile conditions to prevent contamination.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna Straus, clone number 5
- Source: from at least the third generation (i.e. the third brood) obtained with a non-cyclic parthogenesis reproduction.
- Age at study initiation: less than 24 hours old.
- Method of bredding: the daphnids breeding was carried out in closed bottles placed in a climatic cha
mber free from any toxic vapour and in medium M4.
- Feeding during test: None
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- None
Test conditions
- Hardness:
- 250 mg/L of CaCO3
- Test temperature:
- 19.9 - 20.1°C
- pH:
- 8.1
- Dissolved oxygen:
- 8.8 mg/L
- Salinity:
- No data
- Conductivity:
- No data
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
Measured concentration: 101.91 mg/L (at initial time) and 97.7 mg/L (after 24 hours of exposure) - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass test tube
- Type: closed
- Each glass test tube (sterilized by autoclave) contained 10 mL of test solution and five daphnids; they were covered in order to avoid evaporation and dust deposition.
- Renewal rate of test solution: Renewal of test solutions at 24h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
OTHER TEST CONDITIONS
- Light intensity: Darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observations of the daphnid's immobility and behaviour were carried out after 24 and 48 h in control and exposed groups.
- Any sign of stress observed on the daphnids after 48 hours of exposure to the test item were reported.
- pH and dissolved oxygen were measured before and after renewal of solutions (including the controls).
RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed at any of the concentration tested. Based on the results of the preliminary test, it has been proposed to perform a limit test at 100 mg/L for the study. This study was conducted on one concentration levels: 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Details on results
- No immobilization was observed at 24 h and 48 h (including controls).
- No sign of stress was observed on the mobile daphnids after 48 h of exposure - Results with reference substance (positive control):
- The last toxic response obtained on the reference item K2Cr2O7 (June 27, 2016) gives an EC50-24h of 1.24 mg/L (1.13 - 1.37), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6 - 2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The results obtained for the test item "ANAGELINE AT" on the toxicological endpoint "immobilisation" give an EC50-24h and an EC50-48h > 100 mg/L, based on nominal test item concentration.
- Executive summary:
The aim of this study was to assess the acute toxicity of the test item "ANAGELINE AT" on the freshwater invertebrate Daphnia magna, according to the OECD 202 guideline. The study was performed at 100 mg/L, limit test, under semi-static conditions, with GLP compliance.
The test was performed in sterilized vessels and sterile conditions with renewal at 24 h of the test solution. Groups of thirty Daphnia magna, less than 24 h old, were exposed for 48h to a control solution (Elendt M4 medium) and to the test item “ANAGELINE AT”, prepared in Elendt M4 medium.
The test item concentration was prepared under sterile conditions in order to obtain the required nominal concentration of 100 mg/L Elendt M4 medium.
The concentrations which immobilise 50% of the daphnids exposed to the test item after 24 and 48 hours, reported as EC50 -24h and EC50 -48h were evaluated, relative to the tested concentration: 100 mg/L. After 48 h, no immobilization was observed in any test tubes.
In order to verify the initial concentrations and maintenance of the exposure concentrations of the test item during the ecotoxicological testing, a chemical analysis of "ANAGELINE AT" in the test solutions was performed. At the nominal concentration of 100 mg/L, the test item "ANAGELINE AT" is considered as stable in the testing conditions because the measured concentrations of the "ANAGELINE AT" did not vary more than +/- 20% of initial measured concentration during the test.
In the control, not more than 10 % of the daphnids showed an immobilization. In addition, the dissolved oxygen concentration was determined to be higher than 3 mg/L in the control and test vessels. Thus, the validity criteria were respected.
The results obtained for the test item "ANAGELINE AT" on the toxicological endpoint "immobilisation" give an EC50-24h and an EC50-48h > 100 mg/L, based on nominal test item concentration.
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