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Diss Factsheets
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EC number: 215-413-3 | CAS number: 1326-03-0
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
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/December),1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The test uses a single rabbit ear to indicate the Comedogenicity and irritancy of Rhodamine B
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- EC Number:
- 201-383-9
- EC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- Cas Number:
- 81-88-9
- Molecular formula:
- C28H31N2O3.Cl
- IUPAC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthenium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Rhodamine B
- Molecular formula : C28H31N2O3.Cl
- Molecular weight : 479.017 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): 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthenium chloride
- Common Name: Rhodamine B
- Molecular formula : C28H31N2O3.Cl
- Molecular weight : 479.017 g/mol
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: No data
Age at study initiation: No data
Weight at study initiation: 2-3 kg
Fasting period before study: No data
Housing: singly housed, in suspended cages
Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
Water (e.g. ad libitum): water, ad libitum
Acclimation period: No data
ENVIRONMENTAL CONDITIONS
Temperature (°C): No data
Humidity (%):No data
Air changes (per hr): No data
Photoperiod (hrs dark / hrs light): 12 hour light and 12 hr dark cycle
IN-LIFE DATES: From: No data To: No data
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: propylene glycol
- Controls:
- yes
- Amount / concentration applied:
- Dose of 1ml of the test material was applied once daily for five days per week for 2 weeks.
- Duration of treatment / exposure:
- 2 weeks
- Observation period:
- 2 weeks
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
Area 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: No data
REMOVAL OF TEST SUBSTANCE
Washing (if done): No data
Time after start of exposure: No data
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 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
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema observed
Any other information on results incl. tables
Table 1: Ingredients and their Comedogenicity and Irritancy
Test chemical |
Comedogenicity* [Grade 0-5] |
Irritancy** [Grade 0-5] |
Rhodamine B |
2 |
0 |
*Comedogenicity or the ability of test substance to produce follicular hyperkeratosis
** Irritancy or ability of test substance to produce surface epithelial irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test uses a single rabbit ear to indicate the Comedogenicity and irritancy of Rhodamine B. The irritancy produced by Rhodamine B was graded from 0 – 5. It falls under Grade 0 (no irritation observed).
Hence it can be concluded that Rhodamine B was not irritating to rabbit ears. - Executive summary:
The test uses a single rabbit ear to indicate the Comedogenicity and irritancy of Rhodamine B. Rhodamine B was 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 free from mites were used. Three rabbits, weighing two to three kilograms, were used for each assay. Animals were housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals were maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of the test material was 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 the chemical 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.
Rhodamine B falls under Grade 0 (no irritation observed).Hence it can be concluded that Rhodamine B was not irritating to rabbit ears.
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