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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- according to GLP, and Commission guideline 91/507/EEC Pharmaceutical Affairs Bureau, Notifications 24 & 88, US-FDA for Pharmaceuticals. 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:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 91/507/EEC, Pharmaceutical Affairs Bureau Notifications 24 & 88 guidance, US-FDA guidance on acute testing for Pharamceuticals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: rising dose study
- Limit test:
- no
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 (Sigma-Aldrich Co Ltd, Poole, Dorset), batch no.70522014
White powder
Stored in refrigerator (1-10 degrees Celsius)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Crl:NZW/Kbl.BR strain obtain from Charles Rivers Ltd, Margate, Kent.
Body weight range : 2.214 to 2.425 kg (males) and 2.061 to 2.340 kg (females) on Day -1 (day before 1st dosing occasion)
Age : 11 to 13 weeks old
Acclimation period: 6 days
Animals were sex-separated and kept individually in cages. Water was given ad libitum, and feed was freely available but consumption was measured.
Animals were kept under standard conditions for rabbits.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22 deg C
- Humidity (%): 40-80%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs daily
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1% in water
- Details on oral exposure:
- Oral exposure was by gavage , and once weekly.
- Doses:
- Doses were 5, 7.5, 12.5, 17.5, 25, 40, 55, 100, 200, 300, 450, 600, 750, 900, 1100, and 1500 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
except for the 2 sets 300, 450, 600 mg/kg bw and 750, 900 and 1100 mg/kg bw , the group of 6 animals was subdivided into 3 sets consisting of one male and one femals for each dose. - Control animals:
- yes
- Details on study design:
- In order to determine the maximum tolerated dose, increasing doses were applied with one week interval for recovery.
Mortalities were recorded as well as clinical signs of toxicity.
The maximim tolerated dose was based on the observation of clinical changes and variations in weight gain and food intake. - Statistics:
- no
Results and discussion
- Preliminary study:
- none
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: reduced body weight gain and food consumption
- Sex:
- male/female
- Dose descriptor:
- LDLo
- Effect level:
- > 700 - < 910 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: toxic clinical signs observed
- Mortality:
- Mortality occurred at 1500 mg/kg bw (animals were killed for humane reasons in moribund condition).
- Clinical signs:
- other: Self-mutiliatuuin of some animals at 750 and 900 mg/kg bw.
- Gross pathology:
- No gross pathology findings were observed at any dose levels.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions and regarding observations of clinical signs, body weight gain and food consumption, LD0 is defined at 600 mg/kg bw and a LDLo value range between 700 to 910 mg/kg in rabbits.
- Executive summary:
Under the test conditions and regarding observations of clinical signs, body weight gain and food consumption, LD0 with no detectable effect is defined at 600 mg/kg bw, and a LDLo range defined between 700 to 910 mg/kg in rabbits.
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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