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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This Guinea pig maximisation test realised in 1999 before the publication of the Murine Local Lymph Node Assay (LLNA) Performance standards by ECVAM in 2008.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: C. River - 76140 CLEON
Weight: about 200 to 250 g at the time of trial
Acclimatation: at least 5 days in the animal house of laboratory.
Housing: the animals are kept in individual polystyrene cages of standardized dimension with perforated floor. These cages are placed in temperature controlled animal shelter where the temperature is between 18 and 22°C and the relative humidity is maintained at between 50 and 80%
Food: aliment réf: 106, UAR - Villemoisson 91360 EPINAY SUR ORGE
Water: tap water ad libitum in sterilizable makrolon bottles equipped with stainless steel pipettes.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Group 1:
- 2 intradermic injections of Freunds's complete adjuvant (50% dilution in the sterile isotonic solution of NaCl)
- 2 injections of 0.1 ml of NaCl 0.9%
Group 2:
- 2 intradermic injections of Freunds's complete adjuvant (50% dilution in the sterile isotonic solution of NaCl)
- 2 intradermic 0.1 ml injections of the test item diluted to 50% in NaCl 0.9%
- 2 intradermic 0.1 ml injections ofof a mixture of equal volumes of the two previous solutions - Day(s)/duration:
- 10 days.
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.25 ml of the undiluted test item (which is the MNIC determined)
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Induction phase and Trigger phase:
Group 1 treated: 5 females to check for the absence of a primary skin irritant effect at the time of the trigger phase
Group 2 control: 10 females used to assess whether the product has any sentizing power
Determination of the MNIC (Maximal non-Irritant Concentration)
3 animals - Details on study design:
- Preliminary study: determination of the Maximum non-irritant concentration:
The dorso-lumbar zone of 3 animals was shaved and the hair was removed with cream. Then, the animals received two differents concentrations of the products under semi-occlusive dressing for 24 hours:
- undiluted
- in solution 1/2
- in solution 1/4
- in solution 1/8
- in solution 1/16
- in solution 1/32
in NaCl 0.9%
Induction phase (as described above)
Trigger phase (as described above cf. challenge) - Challenge controls:
- Group 2: 10 females used to assess whether the product has any sentizing power
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2-4 dinitrobenzene : 1% in alcohol tested in the same conditions dispayed 100% of positive reactions
Results and discussion
- Positive control results:
- 1-chloro-2-4 dinitrobenzene : 1% in alcohol tested in the same conditions dispayed 100% of positive reactions
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.25 ml of the undiluted test item (which is the determined MNIC)
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no sensitization effect observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.25 ml of the undiluted test item (which is the determined MNIC)
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no skin sensitization effect observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The lesions observed following the trigger application of DTP Riz at the Maximum Non Irritant Concentration did not display any sensitizing potential in the animals tested.
The positive reference (1-chloro-2-4 dinitrobenzene 1%) tested in the same conditions displayed 100% of positives reactions.
The Test Item displays a very slight sensitizing power in the albino guinea pig. - Executive summary:
The test item was tested according to the OECD 406 guidelines.
The determination of the MNIC was made by observations on 3 animals submitted to the following concentrations: undiluted product, 1/2; 1/4; 1/8; 1/16 and 1/32 in NaCl 0.9%.
The non diluted product does not provoke an orthoergic irritative skin irritation. The pure product is used for the trigger phase.
The lesions observed following the trigger application of DTP Riz at the Maximum Non Irritant Concentration did not display any sensitizing potential in the animals tested.
The positive reference (1-chloro-2-4 dinitrobenzene 1%) tested in the same conditions displayed 100% of positives reactions.
The Test Item displays a very slight sensitizing power in the albino guinea pig.
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