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Diss Factsheets
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EC number: 209-967-5 | CAS number: 599-61-1
- 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
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
Dapsone is not only an anti-leprosy and anti-malaria drug but has also some anti-epileptic activity at concentrations used previously for the first two treatments.
Dapsone given at a dose of 100 mg/person/day on a long-term bases to women with malaria, leprosis, and HIV sero-positve condition does not show any severe adverse effects to mother and unborn child. However, confounding factors such as other drugs in combination with dapsone, adverse effects due to the illness itself, and incomplete data recording in most studies cannot exclude an effect on the unborn child and on suckling babies.
The safety results of a Human Phase III study (Africa) based on FDA with an approved study protocol demonstrated that Chlorproguanil-Dapsone-Artesunate (CDA) (as well as Chlorproguanil-Dapsone -CD; LAPDAP™) have an unacceptable safety risk in patients with G6PD deficiency, due to the propensity of the DDS component to cause severe haemolytic anaemia in such patients. Since the prevalence of G6PD deficiency in sub-Saharan Africa is relatively high (approximately 10-20%) and it would be impractical to screen patients for the deficiency prior to treatment, CDA does not fulfil the requirements for a suitable antimalarial treatment in Africa, where the WHO advocates empiric use of antimalarials for treatment of fever. As a result, further development of CDA has been discontinued.
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.