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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
Skin sensitisation - HRIPT
Based on the study results, the test substance was determined to be non skin sensitiser (CPT, 2004).
Additional information
Human Repeat Insult Patch Test (HRIPT)
A study was conducted to determine by repetitive epidermal contact the potential of a test substance, Hydrolysed keratin (Purity: Unknown) to induce primary or cumulative irritation and/or allergic contact sensitization, with compliance with ICH E6 GCP (Good Clinical Practice) and 21 CFR Part 50 and 56. Fifty eight human volunteers, male and female, ranging in age from 18 to 79 years, were selected for this evaluation (Fifty one human volunteers completed this study, while remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test substance). Approximately 0.2 mL of the test substance, or an amount sufficient to cover the contact surface, was applied to the 1" x 1" absorbent pad portion of a clear adhesive dressing. This was then to the upper back between the scapulae to form a semi-occluded patch. Patches were applied three times per week for a total of nine applications. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty four hours after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one makeup day was permitted. This day was added to the Induction period. With the exception of the first supervision Induction Patch reading, if any test site exhibited a moderate (2-level) reaction during the Induction Phase, application was moved to an adjacent area. Applications are discontinued for the remainder of this test phase, if a moderate (2-level) reaction observed on this new test site. Applications would also be discontinued if marked (3- level) or severe (4-level) reactivity was noted. Rest periods consist of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal. Approximately two weeks after the final Induction patch application, a Challenge patch was applied to a Virgin test site adjacent to the original Induction patch site, following the same procedure for Induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application. Based on the grading and evaulations of study results, the study author concluded that test substance did not induce dermal irritation or allergic contact sensitization throughout the test interval. Under the study conditions, test substance did not indicate a potential for dermal irritation or allergic contact sensitization (CPT, 2004).
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.