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Diss Factsheets
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EC number: - | CAS number: -
- 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 studies performed on analogues (hydrolysed proteins obtained from different animal and vegetable sources) were prepared mostly for the safety assessment for cosmetic ingredients. Case studies on human sensitization show that the peptides with MW > 3.5 kDa might have sensitizing potential while for the peptides of MW< kDa this potential is very low and are considered safe for use on skin.
In order to cross-link IgE in sensitised individuals, a protein needs to have a minimum size which is assumed to be in the order of 3 kDa. It can be argued that proteins of this size are also unlikely to induce clinically relevant (type I) sensitisation. The CIR Expert Panel concluded that wheat protein hydrolysate is safe for use in cosmetics when formulated to restrict peptides to a weight average MW of 3.5 kDa or less (CIR (2014)).
The SCCS considers the use of hydrolysed wheat proteins safe for consumers in cosmetic products, provided that the maximum molecular weight average of the peptides in hydrolysates is 3,5 kDa.
All peptides in the registered substance have the MW< 1 kDa so are not expected to cause any skin sensitization.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The provided key study was performed on the protein hydrolysate derived from wheat and considered a relevant source for the read-across assessment of the properties of corn gluten hydrolysate (analogue approach).
All protein hydrolysates can be regarded as analogues with similar properties on basis of having common precursors (proteins) and common breakdown products (amino acids, peptides) through physical and/or biological processes which result in structurally similar degradation products (similarity through biotransformation).
The animal and vegetable cells are formed mainly by proteins, which constitute more than the half of the dry weight of the cell. These components and their degradation products are constantly present in the animal and human diet and in the environment.
After ingestion, proteins are hydrolyzed in the gastrointestinal tract by proteolytic enzymes derived from the pancreas resulting in the release of dipeptides, tripeptides and free amino acids. Digestion is further enhanced by proteases, such as aminopeptidase N, that are located in the plasma membrane of the intestinal cells. Single amino acids, as well as di- and tripeptides, are transported into the intestinal cells from the lumen and subsequently released into the blood for absorption by other tissues. The final digestion products are then used by the cells for the biosynthesis of new specific proteins, or they can then undergo further amino acid catabolism, where they are utilized as an energy source.
Proteins derived from different sources has different amino acid profiles. The hydrolysates also have different compositions depending on the manufacturing process and hydrolysing agents used. Differences also include oligopeptides and peptides chains length and structure. While these differences might be meaningful when considering the use of protein hydrolysates as food supplements and their beneficial impact on health condition, they do not make significant difference for the toxicological or ecotoxicological profiles of particular hydrolysates. All proteins, regardless their source and structure, are in the end subject to the same degradation processes and metabolic pathways. - Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0,5 ml of 50% solution
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- slight patchy erythema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0,5 ml of 50% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0,5 ml of 50% solution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight patchy erythema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0,5 ml of 50% solution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight patchy erythema
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The subatnce is not classified as sensitizingto skin
- Executive summary:
The key study was performed on the protein hydrolysate derived from pig trachea and considered a relevant source for the read-across assessment of the properties of corn gluten hydrolysate (analogue approach).
All protein hydrolysates can be regarded as analogues with similar properties on basis of having common precursors (proteins) and common breakdown products (amino acids, peptides) through physical and/or biological processes which result in structurally similar degradation products (similarity through biotransformation).
The animal and vegetable cells are formed mainly by proteins, which constitute more than the half of the dry weight of the cell. These components and their degradation products are constantly present in the animal and human diet and in the environment.
The lack of sensitizing properties of protein hydrolysate shown in the study is indeed in line with expectations. Protein hydrolysates are present in various cosmetics producsc and have been assessed for their safety for skin contact
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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.