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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
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
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: DEPRE or IFFA CREDO
weight: about 250 g at the time of the trial
Acclimatation: at least 7 days in the animal selter of the laboratory were the trial is carried out
Housing: the animal are kept in individual polystyrene cages of standardized dimensions with perforated floor. These cages are places in a temperature controlled animal shelter where the temperature is 22°C+-3°C and the relative humidity is maintained between 30 and 75%
the air is filtered and evacuated.
Food: aliment A04, UAR - VILLEMOISSON - 91360 EPINAY SUR ORGE
Water: tap water provided ad libitum in sterilizable makrolon bottles equiped with stainless steel pipettes.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test item was administrated with the syringe and the gastro-esophageal probe at the chosen dose of 2 g/kg body weight, according to study report.
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- The animals were observed regularly on the day of administration (immediately, within 15 minutes after gavage and 6h after administration) and then at least once a day for 14 days.
The various parameters observed were: Apathy, Excitation, Palpebral ptosis, sleeping, comas, tembling, convulsions, refusal of food or drink, modification of volume or appearance of feces or urines, mouth, anal ou nasal bleeding and mortality.
Animals were weighed on D0, D7 and D14. - Statistics:
- none
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- none
Applicant's summary and conclusion
- 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 toxic effects observed at that dose level.
- Executive summary:
The test item was administered to a group of 5 males and 5 females 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. 401.
No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.
In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
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.