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Diss Factsheets
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EC number: 477-700-1 | CAS number: 883794-93-2
- 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
Oral (OECD 423), rat (female): LD50>2000 mg/kg bw
Inhalation: no data available
Dermal (OECD 402), rat (male/female): LD50>5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (reliability 1). The information is sufficient for hazard assessment leading to an endpoint conclusion in accordance with Annex VIII, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5. of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (reliability 1). The information is sufficient for hazard assessment leading to an endpoint conclusion in accordance with Annex VIII, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information is sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5. of Regulation (EC) No 1907/2006.
Additional information
Acute toxicity: via oral route
A reliable key study is available, conducted according to OECD guideline 423 and in compliance with GLP. 6 female Sprague-Dawley rats in two steps were given the test item at a single dose of 2000 mg/kg bw. No mortality occurred throughout the study period and no clinical signs of toxicity were noted. Body weight development was as expected for this strain and age. Thus, the LD50 for the registered substance was set at >2000 mg/kg bw in female rats (Research Toxicology Centre, 2004).
Acute toxicity: via inhalation route
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5. of REACH Annex VIII) does not need to be conducted as reliable data via the oral and dermal routes are available.
The commercial product is a granulated material. The substance is fixed in a matrix by embedding in polymer. The granulate size is approx. 1 cm in length and approx. 0.4 cm in diameter, therefore, exposure via the inhalation route is unlikely.
Acute toxicity: via dermal route
A reliable key study is available, conducted according to OECD guideline 402 and in compliance with GLP. 5 Sprague-Dawley rats per sex were administered the test item at a single dose of 5000 mg/kg bw (limit test) for 24 h under semi-occlusive conditions. Residual test item was washed off with water at the end of the exposure period. No mortality occurred throughout the study period and no clinical signs of toxicity were noted. The animals did not show any signs of dermal irritation throughout the study period. Body weight development was as expected for this strain and age. Thus, the LD50 for the registered substance was set at >5000 mg/kg bw in both male and female rats (Safety Evaluation Center Shenyang Res Inst Chemical Industry Ltd., 2014).
Justification for selection of acute toxicity – oral endpoint
The available key study was selected for assessment. The study was conducted according to OECD test guideline 423 and in compliance with GLP.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5. of REACH Annex VIII) does not need to be conducted as reliable data via the oral and dermal routes are available.
Justification for selection of acute toxicity – dermal endpoint
The available key study was selected for assessment. The study was conducted according to OECD test guideline 402 and in compliance with GLP.
Justification for classification or non-classification
The available information on the registered substance is reliable and suitable for classification. The data do not meet the criteria for classification for acute toxicity according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC.
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.