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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was performed in a single male to determine dermal absorption. The read-across of toxicological data is considered justified because 4,4’-DDS (dapsone) and 3,3’-DDS are structural isomers with identical mol mass, identical elemental composition and identical functional groups. To the best of our knowledge, only Dapsone is used as a pharmaceutical. It is not known whether 3,3’-DDS acts as 4,4’-DDS as a folate synthesis inhibitor in microorganisms.The main toxicological hazard of 4,4’-DDS is the methemoglobin formation. This is due to the aromatic amine substituent of the molecule, which is present in both isomers. It is concluded that the main toxicological hazard of 3.3’-DDS is also methemoglobin formation. Both isomers do not show a structural alert for mutagenicity. The toxicological and ecotoxicological hazard profiles of both isomers are considered to be identical. A read-across 1:1 is considered reasonable and justified due to the very small structural difference of both substances.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test material
- Reference substance name:
- Dapsone
- EC Number:
- 201-248-4
- EC Name:
- Dapsone
- Cas Number:
- 80-08-0
- Molecular formula:
- C12H12N2O2S
- IUPAC Name:
- 4,4'-sulfonyldianiline
- Details on test material:
- dapsone
Constituent 1
Administration / exposure
- Duration of exposure:
- Rats and rabbits: 28 days
Humans: 1 day - Doses:
- 50 mg/kg/day for rats and rabbits (28 days), 1.67 mg/kg (single application) for humans
- Details on study design:
- Dapsone and N-acetyl dapsone concentrations in nonclinical samples were analyzed with HPLC and mass spectroscopy. The method was adequately validated and had acceptable limit of quantitation.
Results and discussion
- Conversion factor human vs. animal skin:
- Rat and rabbit skin absorption is about 20x higher than human skin
Applicant's summary and conclusion
- Conclusions:
- In the FDA review of non-disclosed studies on the safety pharmacology of a dapson gel it is summarised that topically applied dapsone is bioavailable at 10-20% in rats and rabbits. In humans, less than 1% of a topically applied dose is bioavailable.
- Executive summary:
In the FDA review of non-disclosed studies on the safety pharmacology of a dapson gel it is summarised that topically applied dapsone is bioavailable at 10-20% in rats and rabbits. In humans, less than 1% of a topically applied dose is bioavailable.
Rat male (topical) Dose: 50 mg/kg Cmax: 2613 ng/ml AUC: 32587 ng hr/mL
Rat female (topical) Dose: 50 mg/kg Cmax: 10909 ng/ml AUC: 159928 ng hr/mL
Rabbit male (topical) Dose: 50 mg/kg Cmax: 1469 ng/ml AUC: 14916 ng hr/mL
Rabbit female (topical) Dose: 50 mg/kg Cmax: 1864 ng/ml AUC: 13427 ng hr/mL
Human male (topical) Dose: 1.37 mg/kg Cmax: 17.1 ng/ml AUC: 349 ng hr/mL
Human female (topical) Dose: 1.37 mg/kg Cmax: 22.3 ng/ml AUC: 481 ng hr/mL
Human male (oral) Dose: 1.67 mg/kg Cmax: 1375 ng/ml AUC: 52641 ng hr/mL
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.
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