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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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:
- performed according to GLP and OECD guideline 474. 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:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
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, batch no. 70522014, white powder, purity 99.69%, stored at 1-10 degrees C in the dark.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River-UK Ltd
- Age at study initiation: 7 weeks
- Weight at study initiation: 26-33g
- Diet (e.g. ad libitum): availabe ad-libitum
- Water (e.g. ad libitum): availabe ad-libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 deg C
- Humidity (%): 52-61%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 1% methylcellulose in water
- Details on exposure:
- Groups of 8 males mice (as there was no evidence of sex-related differences in toxicity in the range finding test) were used for each dose groups and one control group. Dose levels were 0, 43.75, 87.5, 175 mg/kg bw/day in the main experiment. A positive control group of 8 male mice received 40 mg/kg cyclophosphamide once on day 2 of the experiment.
- Duration of treatment / exposure:
- 2 consecutive days
- Frequency of treatment:
- daily once
- Post exposure period:
- none
- No. of animals per sex per dose:
- 8 males per dose (as no evidence of sex-related differences in toxicity was revealed in the range finding test)
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- cyclophosphamide, 40 mg/kg bw once on day 2
Examinations
- Tissues and cell types examined:
- Bone marrow were analysed for numbers of micronucleated polychromatic erythrocytes.
- Details of tissue and slide preparation:
- femours were excised and the content washed out with a syringe into 1% fetal bovine serum in RPMI medium
- Evaluation criteria:
- Slides had to have at least 1000 scorable cells (PCE and NCE).
A statistical increase in CE is necessary,
the frequency of PCE is higher than the historical control range. - Statistics:
- Statistics was applied
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- A significant increase in PCE was found with Dapsone as compared to the control group, but a significant increase with the positive control was observed, thus validating the study.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Based on the available Mouse micronucleus test (bone-marrow) it can be concluded that Dapsone is not mutagenic in-vivo. - Executive summary:
In the present mouse micronucleus study, no increase in PCE was observed with Dapsone, while the positive control Cyclophosphamide showed a significant increase in PCE. With Dapsone the mice were treated up to the highest dose not causing mortality as shown in the pre-experiment.
Based on the absence of any increase of PCE with Dapsone at any dose level tested, it is concluded that Dapsone has no mutagenic potential in-vivo.
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