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Diss Factsheets
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EC number: 207-395-0 | CAS number: 467-62-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from National Technical Reports library (NTRL)
Data source
Reference
- Reference Type:
- grey literature
- Title:
- Delayed Contact Hypersensitivity in Guinea Pigs
- Author:
- National Technical Reports library (NTRL)
- Year:
- 1 991
- Bibliographic source:
- National Technical Reports library (NTRL),AMER CYANAMID CO, Microfiche Number: OTS0534436,1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine if a Dapsone causes delayed hypersensitivity in guinea pigs as determined by the measurement of skin reactivity.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 4,4'-Diaminodiphenyl Sulphone
- Cas Number:
- 80-08-0
- Molecular formula:
- C12H12N2O2S
- IUPAC Name:
- 4,4'-Diaminodiphenyl Sulphone
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): FXM-355 (Dapsone)
- Molecular formula (if other than submission substance): C12H12N2O2S
- Molecular weight (if other than submission substance): 248.301 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: no data
- Impurities (identity and concentrations): no data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): FXM-355 (Dapsone)
- Molecular formula (if other than submission substance): C12H12N2O2S
- Molecular weight (if other than submission substance): 248.301 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: no data
- Impurities (identity and concentrations): no data
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Perfection Breeders, Douglassville, Pennsylvania
- Age at study initiation:
- Weight at study initiation: 300 - 500 gm
- Housing: Guinea pigs were housed two per cage in wire metal cages. Waste material removed daily. Cages and feeders
sanitized weekly.
- Diet (e.g. ad libitum): Wayne Guinea Pig Diet, ad libitum, food was checked
daily and added or replaced as needed. Feeders were designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: five (5) days
ENVI\RONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 30°C
- Humidity (%):30-70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: DNCB (0.3%) - Ethanol (80%)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 14 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: DNCB (0.3%) - Ethanol (80%)
- Concentration / amount:
- 100%
- Day(s)/duration:
- No data
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Test article – twenty (20)
Positive Control – ten (10)
Naive challenge – four (4)
Dose-range - four (4) - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: six hours
- Test groups: twenty (20) guinea pig
- Control group: Positive Control – ten (10)
- Site: 4 sites
- Frequency of applications: once a week for three weeks, a total of three six-hour
Inductions.
- Duration: 30 days
- Concentrations: 400 mg/ induction site (100%)
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 14 days after
- Exposure period: 30 min
- Test groups: twenty (20) guinea pig
- Control group: Positive Control – ten (10)
- Site: naive site on the left side
- Concentrations: 400 mg
- Evaluation (hr after challenge): 24. 48 hrs
OTHER: Local and systemic effects W8re
observed. - Positive control substance(s):
- yes
- Remarks:
- 1-Choloro-2,4-dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin reaction were observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin reaction were observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Delayed Contact Hypersensitivity in Guinea Pigs
Incidence and Severity of Responses at Challenge
|
Naive Site |
|||
|
24 hours |
48 hours |
||
Test Article |
Incidence |
Severity |
Incidence |
Severity |
FXM-355 (100 %) |
0/17 |
0.1 |
0/17 |
0 |
Naive Animals FXM-355 (100 %) |
0/4 |
0 |
0/4 |
0 |
DNCB (0.3%) |
9/9 |
2.4 |
9/9 |
2.6 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No positive responses were observed in guinea pig receiving dapsone at a 100 % concentration at 24 or 48 hours after the challenge. Dapsone did not cause hypersensitivity in quinea piqs.
Hence Dapsone is not sensitizer to the skin of Guinea pig. - Executive summary:
In a preliminary dose-range finding study, four animals (two males and two females) were exposed to one concentration (as received) of Dapsone at four skin sites. Based upon the results of the dose-range finding study, the dose chosen for induction was 100 %.
Dapsone was dermally applied to twenty guinea pigs (ten males and ten females for a total of three six-hour insult periods at a 100 % concentration.
An additional group of ten guinea pigs (five males and five females) was treated with 1-chloro-2,4-dinitrobenzene at 0.3% concentration for a total of three six-hour insult periods. Fourteen days after the last induction period, all animals were challenged at a naive site. A positive response was elicited
in the animals receiving the positive control article, 1-chloro-2,4-dinitrobenzene (DNCB).
Redness and edema scores in all animals at 24 and 48 h recorded after each treatment and at 24 and 48 h after the challenge.
No positive responses were observed in guinea pig receiving dapsone at a 100 % concentration at 24 or 48 hours after the challenge. Dapsone did not cause hypersensitivity in guinea pigs
Hence Dapsone is not sensitizer to the skin of Guinea pig.
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