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Diss Factsheets
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EC number: 619-409-6 | CAS number: 99208-50-1
- 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 vitro
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- Assessment of skin sensitization potential of the substance DOPO-HQ is required to meet the data requirements of Annex VII, Point 8.3 of the REACH regulation. Consideration has been given to testing the substance using in chemico and in vitro test methods to address key events 1, 2 and 3 of the skin sensitization adverse outcome pathway (AOP). Initially, solubility tests were conducted to determine if suitable concentrations of DOPO-HQ could be obtained to conduct an In Chemico Direct Peptide Reactivity Assay (DPRA) according to OECD Test Guideline 442C (key event 1) and an In Vitro human Cell Line Activation Test (h-CLAT) test according to OECD Test Guideline 442E (key event 3). The solubility of DOPO-HQ in the recommended solvents was found to be limited, such that if negative results were obtained in DPRA and h-CLAT studies it would not be possible to make a firm conclusion on lack of skin sensitization potential. It was considered that whilst conduct of an in vitro ARE-Nrf2 Luciferase (KeratinoSens™) test (or an in vitro ARE-Nrf2 LuSens test) according to OECD Test Guideline 442D (key event 2) might be technically possible, this would only be at low test concentrations of substance and again it would not be possible to reach a firm conclusion on lack of skin sensitization potential. Meanwhile, positive results in the in chemico and in vitro tests, either in isolation or in combination, would not satisfy the EU REACH requirement for concluding whether the substance has the potential to produce significant sensitization in humans (i.e. Category 1A according to EU CLP). Hence, in vivo testing to generate skin sensitization data in accordance with point 8.3.2 of Annex VI to allow hazard and risk assessment is considered justified, the preferred test method being the OECD 429 Local Lymph Node Assay.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Owing to low solubility of the substance DOPO-HQ, the use of in chemico and in vitro test methods to address key events 1, 2 and 3 of the AOP for skin sensitization initiated by covalent binding to proteins is not possible. Hence, in vivo testing in accordance with point 8.3.2 of Annex VII, to generate skin sensitization data suitable for hazard and risk assessment, is considered justified. According to EU REACH, the preferred in vivo test method is the OECD 429 Local Lymph Node Assay. Scientific justification should be provided for use of a different in vivo test method.
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.