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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Protein hydrolyzates, rice bran
- EC Number:
- 305-224-5
- EC Name:
- Protein hydrolyzates, rice bran
- Cas Number:
- 94350-05-7
- IUPAC Name:
- Protein hydrolyzates of Oryza Sativa
- Test material form:
- liquid
- Details on test material:
- yellow liquid
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% S9: S9-mix from the livers of male Sprague Dawley rats
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity testing study: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in
TA 100 strain
Main study - Direct plate incorporation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without
S9-mix in TA 1535, TA 1537, TA 98, TA 100, TA 102 strains
Confirmatory assay - pre-incubation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without
S9-mix in TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains - Vehicle / solvent:
- Sterile and apyrogen physiological serum (NaCl 0.9% w/v)
Controls
- Untreated negative controls:
- yes
- Remarks:
- absolute negative control: pontaneous reversion rate
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: - B-Propiolactone without S9 metabolic activation - cis-Diammineplatinum(II) dichloride without S9 metabolic activation - 2-Anthramine with S9 metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM
- Bacteria used in the test was obtained from Unité de Programmation moléculaire et toxicologie
génétique CNRS UA 144 (Institut Pasteur)
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 37 °C for 20 minutes
- Exposure duration: Plates were incubated at 37 ± 1 °C for 48h
NUMBER OF REPLICATIONS: Triplicate plates per dose level - Evaluation criteria:
- The result of the test is considered as negative if the revertant number is below three fold the number of spontaneous reversions for TA 1535 and TA 1537 strains, and below two fold the number of spontaneous reversions fo TA 98, TA 100 and Escherichia Coli WP2 strains with and/or without metabolic activation.
The validity criteria are:
- bacteriostatic activity of the highest concentration shall be equal to or less than 75%
- the spontaneous reversion rate of the absolute negative control shall comply with the laboratory's historical control data.
- the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with laboratory's historical control data
The result of the test is considered positive if a concentration- related increase is obtained in one, or several of the 5 strains, with and/or without metabolic activation; a mutagenic effect is taken into acount for a given concentration of the test substance if the number of revertant colonies is at least two fold that of spontaneous revertant colonies number for TA 98, TA 100 and Escherichia Coli WP2 and 3 fold for TA1535 and TA 1537.
All results must be confirmed in an independent experiment
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, the test substance did not cause any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Echirichia Coli WP2.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were exposed to test item, Nutriskin at the following concentrations:
- Range finding study: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and Escherichia Coli WP2
- Main study - Direct plate incorporation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and Escherichia Coli WP2
- Confirmatory assay - pre-incubation method: 0; 50;150; 500; 1500; 5000 μg/plate, with and without S9-mix in TA 1535, TA 1537, TA 98, TA 100 and Escherichia Coli WP2
Metabolic activation system used in this test 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats. Vehicle and negative and positive control groups were also included in mutagenicity tests.
In a range-finding study, no marked or consistent differences in the number of revertant colonies per plate was observed in various test concentrations and solvent controls of all the tester
strains, both with (10% S9 mix) and without exogenous mammalian S9 activation component in the main assays.
The mean numbers of revertant colonies are fell within acceptable ranges for vehicle control treatments.
Under the test conditions, the test substance did not cause any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and Escherichia Coli WP2.
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