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EC number: 222-656-9 | CAS number: 3567-66-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Comedogenicity and irritancy of commonly used ingredients in skin care products
- Author:
- JAMES E. FULTON, JR
- Year:
- 1 989
- Bibliographic source:
- J. Soc. Cosmet. Chem., 40, 321-333 (November/Decembe)
Materials and methods
- Principles of method if other than guideline:
- The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- D&C Red 33
- IUPAC Name:
- D&C Red 33
- 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-(phenylazo)naphthalene-2,7-disulphonate
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): D&C Red 33- Molecular formula (if other than submission substance): C16-H13-N3-O7-S2.2Na- Molecular weight (if other than submission substance): 467.3889 g/mol- Substance type: Organic- Physical state: Solid -Purity- No dtata available.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALSSource: Age at study initiation:Weight at study initiation: 3 kg Fasting period before study:Housing: singly housed, in suspended cagesDiet (e.g. ad libitum): Purina Rabbit Chow, ad libitumWater (e.g. ad libitum): water, ad libitumAcclimation period:ENVIRONMENTAL CONDITIONS Temperature (°C): Humidity (%): Air changes (per hr): Photoperiod (hrs dark / hrs light): 12 hour light and 12 hr dark cycle
Test system
- Type of coverage:
- other: Entire inner surface of one ear
- Preparation of test site:
- other: A colony of rabbits that had genetically good ears and which were free from mites were used for the assay
- Vehicle:
- other: The test chemical was mixed in propylene glycol at a 9 to 1 dilution for testing.
- Controls:
- other: Other ear acted as control.
- Amount / concentration applied:
- Dose of 1ml of the test material
- Duration of treatment / exposure:
- The test material was applied once daily for five days per week for 2 weeks.
- Observation period:
- No data
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITEArea of exposure: Ear% coverage: A dose of 1ml of the test chemical is applied and spread once daily to the entire inner surface of one ear five days per week for 2 weeks.Type of wrap if used:REMOVAL OF TEST SUBSTANCEWashing (if done):Time after start of exposure:SCORING SYSTEM: The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows: 0 = No irritation1 = few scales, no Erythema2 = diffuse scaling, no Erythema3 = Generalized scaling with Erythema4 = Scaling, Erythema and Edema5 = Epidermal necrosis and slough
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other:
- Time point:
- other: 2 weeks
- Score:
- 2
- Max. score:
- 5
- Reversibility:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients . The irritancy produced by the test chemical was graded from 0 – 5. The test chemical falls under Grade 2 (diffuse scaling, no erythema) Hence it can be concluded that the test chemical is non-irritating to rabbit ears.
- Executive summary:
The test uses a single rabbit ear, to indicate the Comedogenicity and irritancy of group of skin care products that may contain follicular and surface epithelial irritating ingredients. Ingredients are mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated( 10% concentration)A. colony of New Zealand albino rabbits that have genetically good ears and is free from mites is used. Three rabbits, weighing two to three kilograms, are used for each assay. Animals are housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals are maintained on a 12-hourlight and 12-hour dark cycle. A dose of 1 ml of the test material is applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control.
The irritancy produced by repeated application of a chemical or skin care product on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:
0 = No irritation
1 = few scales, no Erythema
2 = diffuse scaling, no Erythema
3 = Generalized scaling with Erythema
4 = Scaling, Erythema and Edema
5 = Epidermal necrosis and slough
The test chemical falls under Grade 2 (diffuse scaling, no erythema)
Hence it can be concluded that the test chemical is non-irritating to rabbit ears. Based on the above result the test chemical D&C Red 33 not classified as skin irritent.
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