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Diss Factsheets
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EC number: 208-534-8 | CAS number: 532-32-1
- 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
Endpoint summary
Administrative data
Description of key information
Case studies are available that indicate that the test substance may be involved in the development of vasculitis or pruritis (Vogt 1999, Asero 2006).
Epidemiological studies showed no evidence of increased level of sensitized patients after the test substance challenge (Brasch 1993 and 2010). In a retrospective study, patients with reported urticaria, with or without angio-oedema, after ingesting meals or products containing the test substance, were challenged with 25, 50 and 100 mg the test substance. 1/37 was reported with an increased plasma IgE level (Nettis 2004).
Freedman (1977) reports effects in 4 of 10 patients (asthma) that were challenged with 20 mg, 80 mg and 300 mg of the test substance in an orange drink at 40 min intervals. The effect was a decrease in measured FEV1.
Twelve healthy volunteers receiving apple juice supplemented with the test substance at 0.1-0.3% (1-3 g) developed clinical symptoms including a stringent peppery taste, fulness of head, frontal headache, nervousness, belching, griping, passage of gas by rectum, nausea, dry mouth, excessive perspiration, itching of skin and scalp, pain in the stomach and vomiting. In addition, effects on urinary excretion (volume, albuminuria and increased specific gravity) were reported (Lucas, 1909). The study was very old, symptoms were self-reported, no analysis of the tested solutions was performed and the information on the subjects is limited (bias cannot be excluded).
The described results are confirmed by challenge tests in patients where of urticaria was reported in 2 of 75 patients (Ros, 1975), as well as in several publications that lack sufficient detail to be considered individually, but provide a weight of evidence of non-sensitization in healthy subjects.
A study by Warin in 111 patients showed effect in 12 of these subjects, but in this study subjects were self-reporting on the effects (Warin 1975), which renders the results less reliable.
Additional information
The available case studies are too limited to allow conclusions on the toxicity of the test substance and to allow derivation of a NOAEL. Epidemiological studies (Brasch, 1993, Brasch 2010) are available that clearly indicate that the test substance does not induce sensitization. Many studies use the human patch test in a single challenge. The validity of this test design is not officially confirmed and therefore the results of the individual tests need to be considered as preliminary. However, in view of the consistence of the results, it can be concluded that based on the information available, no sensitizing properties are associated with the test substance in healthy subjects. In patients with frequent urticaria or asthma, symptoms or exacerbation of the symptoms were observed after challenge with the test substance. A study in healthy volunteers (Lucas 1909) showed effects at low doses, but deficiencies in the study design and bias prohibit proper evaluation of the results.
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