Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 483-300-8 | CAS number: 99580-93-5
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In view of its whole life cycle the substance is either processed under closed system technology or incorporated in polymer matrix when used in treated articles. The exposure situations for workers and consumers could be shown to be negligible low. With this the requirements for exposure based waiving are fulfilled.
Short description of key information:
test waived based on exposure consideration
Justification for selection of Effect on fertility via oral route:
During the whole life cycle exposure with the (solid) substance is very limited. Exposure with fine dust could only be expected after milling or during master batch processing. Both production steps are highly controlled industrial processes where the legal binding OEL for fine dust applies. Therefore exposure with the substance is considered to be very limited/avoided with adequate OC and RMM (LVE, gloves; during charging/discharging also personal respiratory protection). After preparation of the master batches, the substance is closely incorporated into a polymer matrix and inhalation exposure could no longer be expected.
No relevant secondary exposure is considered, as no wastewater results from manufacturing and processing of the substance. The process water of the manufacturing process will be totally recycled in a closed system.
During the whole life cycle of the substance and especially during use in technical plastic articles, the oral, dermal or inhalation exposure of workers could be avoided and no relevant exposure of consumers occurs, as the substance is embedded into a polymer matrix. The information one would obtain from a study for reproduction toxicity was considered to be not needed in order to determine the risk assigned. With view to animal welfare and to avoid unnecessary animal testing, particularly on mammals, it was therefore decided to abdicate such a study.
Effects on developmental toxicity
Description of key information
test waived based on exposure consideration
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The substance is during its whole life cycle is either processed under closed system technology or later during its use incorporated in polymer matrix. The exposure situations for workers and consumers could be shown to be negligible low. With this the requirements for exposure based waiving according to REACH Directive 1907/2006/EU Annex IX, chapter 3, are fulfilled.
Justification for selection of Effect on developmental toxicity: via oral route:
During the whole life cycle exposure with the (solid) substance is very limited. Exposure with fine dust could only be expected after milling or during master batch processing. Both production steps are highly controlled industrial processes where the legal binding OEL for fine dust applies. Therefore exposure with the substance is considered to be very limited/avoided with adequate OC and RMM (LVE, gloves; during charging/discharging also personal respiratory protection). After preparation of the master batches, the substance is closely incorporated into a polymer matrix and inhalation exposure could no longer be expected.
No relevant secondary exposure is considered, as no wastewater results from manufacturing and processing of the substance. The process water of the manufacturing process will be totally recycled in a closed system.
During the whole life cycle of the substance and especially during use in technical plastic articles, the oral, dermal or inhalation exposure of workers could be avoided and no relevant exposure of consumers occurs, as the substance is embedded into a polymer matrix. The information one would obtain from a study for reproduction toxicity was considered to be not needed in order to determine the risk assigned. With view to animal welfare and to avoid unnecessary animal testing, particularly on mammals, it was therefore decided to abdicate such a study.
Justification for classification or non-classification
According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding reproductive toxicity.
Additional information
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.