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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- according th GLP and according to OECD and EC guidelines. 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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UKEMS Guidelines (1990), Japanese MHW (1989) and MAFF (1985) Guidelines and ICH Harmonised Tripartite Guideline (1997)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation 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, solid white powder, received on December 18 1998. Stored at 1-10 degrees C in the dark.
Source : Sigma Aldrich Co Ltd, Gillingham UK
Constituent 1
Method
- Target gene:
- Tryptophan and Histidine-requring genes in Salmonella and Escherichia
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli, other: WP2 pKM101
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Araclor 1254-induced rat liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000, 5000 micrograms/plate in the range-finder experiment
8, 40, 200, 1000, 5000 and 4, 20, 100, 500, 2500 micrograms /plate were used in the main experiments - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- treatment with solvent
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Remarks:
- treatment with appropriate stock positive control solution
- Positive control substance:
- sodium azide
- Remarks:
- other positive controls used were 9-aminoacridine (AAC), 2-aminoanthracene (AAN), 4-nitrochinoline (NQO), and 2-nitrofluorene(2NF)
- Details on test system and experimental conditions:
- the plating assay was chosen for all experiments.
Incubation was for three days in the dark at 37 degrees Celcius. - Statistics:
- M-statistics to check whether ther data were Poisson-distributed,
Dunnetts test to compare the counts of each data point with the control.
Linear regression analysis
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No positive result has been observed in any of the strains .
In addition to E.coli strain E. coli WP2 uvr A pKM 101 also E.coli strain WP2 pKM 101 was tested. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Dapsone did not induce reverse gene mutation in bacteria (4 Salmonella strains and 2 E.coli strains). The concentrations applied showed at the high end some toxicity in the absence and presence of S-9 activating enzymes.
- Executive summary:
A bacterial Ames test acording to OECD guideline 471 and the EC guidelines was performed with the Salmonella strains TA 98, TA 100, TA 1535, and TA 1537, as well as with the Escherichia coli strains WP2 pKM 101, and WP2 uvrA pKM 101.
All strains were tested in the presence and absence of S-9 rat liver activating enzymes. None of the strains showed a significant increase of revertant colonies (mutants) neither in the presence nor in the absence of the metabolic rat-enzymes.
It is therefore concluded that Dapsone is not mutagenic under the bacterial Ames assay.
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