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Diss Factsheets
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EC number: 428-880-5 | 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
Acute oral toxicity: LD50 > 2000 mg/kg bw; Limit-Test, GLP, OECD Guideline Study, Safepharm Laboratories Ltd, 1235/003, 1998.
The test substance is virtually nontoxic after a single oral administration.
Acute dermal toxicity: LD50 > 2000 mg/kg bw; Limit-Test, GLP, OECD Guideline Study, Safepharm Laboratories Ltd, 1235/054, 1998
The test substance is virtually nontoxic after a single dermal application.
Key value for chemical safety assessment
Additional information
There are valid in vivo data available for the assessment of the acute oral and dermal toxicity of the test item.
Acute Oral Toxicity
In the key study, performed as a limit test according to GLP and OECD Guideline 401 (Acute Oral Toxicity), fasted, 8 to 12 weeks old, Sprague Dawley rats (Crl : CD ® (SD) IGS BR, 5/sex/dose) were given a single oral dose (gavage) of the test item (analytical purity unknown) at a single dose of 2000 mg/kg bw (Safepharm Laboratories Ltd, 1235/003, 1989). The test item was diluted in distilled water at a concentration of 0.2 mg/mL and administered at a volume dosage of 10 ml/kg. The animals were observed subsequently for a period of 14 days. All animals were killed and subjected to gross pathology. No mortality occurred during the observation period. No signs of systemic toxicity were noted during the study. The faeces of all animals and the urine of all females were stained orange one to two days after treatment. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
Conclusion: Under the conditions of the study the acute oral median lethal dose (LD50) of the test item was found to be greater than 2,000 mg/kg body weight for male and female rats.
Acute Dermal Toxicity
In the key study,performed as a limit test according to GLP and OECD Guideline 402 (Acute Dermal Toxicity), 8 to 12 weeks old Sprague Dawley rats (Crl : CD ® (SD) IGS BR, 5/sex/dose) were given a single semi-occluded dermal application at a dose level of the test item (analytical purity unknown) of 2000 mg/kg bodyweight (Safepharm Laboratories Ltd, 1235/054, 1989). The exposure period was 24 h and the observation period 14 days. No mortality occurred during the observation period. There were no signs of systemic toxicity or skin irritation during the study. There were no treatment related necropsy findings or changes in body weight.
Conclusion: Under the conditions of the study the acute dermal median lethal dose (LD50) of the test item was found to be greater than 2,000 mg/kg body weight for male and female rats.
Acute Inhalation Toxicity
There are no data available. Due to the physicochemical characteristics and taking into account that the substance shows no general toxic potential after acute oral and dermal application, an acute inhalation study is scientifically unjustified.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute oral or dermal toxicity is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute oral or dermal toxicity is not warranted under Regulation (EC) No.1272/2008.
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