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Diss Factsheets
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EC number: 201-989-3 | CAS number: 90-40-4
- 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 from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion of the Scientific Committee on Consumer Products on Acid Red 33 (C22)
- Author:
- European Commission
- Year:
- 2 007
- Bibliographic source:
- Opinion of the Scientific Committee on Consumer Products on Acid Red 33 (C22), 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Skin sensitization study of D and C red 33 by Guinea pig maximization test was performed on guinea pig
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 222-656-9
- EC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3567-66-6
- Molecular formula:
- C16H13N3O7S2.2Na
- IUPAC Name:
- disodium 5-amino-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Molecular formula : C16H13N3O7S2.2Na
- Molecular weight : 467.3889 g/mol
- Substance type: Organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):D and C Red 33
- Molecular formula : C16H13N3O7S2.2Na
- Molecular weight : 467.3889 g/mol
- Substance type: Organic
- Physical state: solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- intradermal induction: 5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- 25% dilution in 1% CMC
- No. of animals per dose:
- Total:15
Test group:10
Control group:5 - Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:2
- Exposure period:18hr
- Test groups:10
- Control group:5
- Site: nuchal region of left flank
- Frequency of applications: one week after intradermal induction
- Duration:18hr
- Concentrations: intradermal induction: 5% dilution of test item in 1% CMC and in an
emulsion of FCA/physiological saline
Epidermal induction: 25% dilution in 1% CMC
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups:10
- Control group:5
- Site: nuchal region of left flank
- Concentrations: 25% dilution in 1% CMC
- Evaluation (hr after challenge):24 and 48hr
OTHER: pre-treatment of the test areas with 10%sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item before epidermal induction - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% dilution in 1% CMC
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin sensitization not observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% dilution in 1% CMC
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Skin sensitization not observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- Skin sensitization study of D and C red 33 (3567-66-6) by Guinea pig maximization test was performed on guinea pig was considered to be not skin sensitizing.
- Executive summary:
In Guinea pig maximization test of D and C red 33 (3567-66-6) was performed in 15 female SPF guinea pig(10 test group and 5 in control group) also 2-mercaptobenzothiazole used as positive control. In induction phase, intradermal induction given as5% dilution of test item in 1% CMC and in an emulsion of FCA/physiological saline to nuchal region of left flank, then after one week epidermal induction of 25% dilution in 1% CMC given in same region for 18hr, before that pre-treatment of the test areas with 10% sodium-laureth-sulfate (SLS), 24 hours prior to application of the test item given. The animals of the control group were intradermally induced with 1% CMC and FCA/physiological saline and epidermally induced with 1% CMC under occlusion following pre-treatment with 10% SLS. In challenge phase, test material 25% dilution in 1% CMC was applied epidermally on left flank and evaluated after 24hr and 48hr.No indication of skin sensitization was noted. Hence it is considered that D and C red 33 (3567-66-6) was not skin sensitizing in guinea pig by Guinea pig maximization test.
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