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Diss Factsheets
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EC number: 209-876-0 | CAS number: 596-03-2
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer-reviewed scientific journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Application of Sensitive Mouse Lymph Node Assay for Detection of Contact Sensitization
- Author:
- Yoshiaki Ikarashi, Toshie Tsuchiya and Akitada Nakamura
- Year:
- 1 996
- Bibliographic source:
- JOURNAL OF APPLIED TOXICOLOGY, VOL. 16(4), 349-354 (1996)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- In the SLNA as well as the LLNA, the lymph node cell (LNC) proliferation is measured by incorporation of radioactive (3H) methyl thymidine (3HTdR).
- GLP compliance:
- not specified
- Type of study:
- other: sensitive mouse lymph node assay (SLNA)
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Erythrosine- Molecular formula : C20H6I4Na2O5- Molecular weight : 879.86g/mol- InChl Key: RAGZEDHHTPQLAI-UHFFFAOYSA-L-Substance type- Organic- Physical state: Solid (powder)-Purity-: Commercial grade dye without purification was used
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Japan SLC Inc, Shizuoka,Japan- Age at study initiation: 6-8 weeks old- Weight at study initiation: No data available- Housing: No data available- Diet (e.g. ad libitum): No data available- Water (e.g. ad libitum): No data available- Acclimation period: No data availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-LIFE DATES: From: To: No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: For intra-dermal injection: saline and For topical injection : Dimethyl sulphoxide
- Concentration / amount:
- No data available
Challengeopen allclose all
- Route:
- other: Topical application
- Vehicle:
- other: For intra-dermal injection: saline and For topical injection : Dimethyl sulphoxide
- Concentration / amount:
- No data available
- No. of animals per dose:
- 3 mice
- Details on study design:
- RANGE FINDING TESTS: No data availableMAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 1- Exposure period: No data available - Test groups: 3 - Control group: No detailed data available- Site: Two sites of the abdominal skin at both sides of the ventral midline- Frequency of applications: 1- Duration: 5 days- Concentrations: 50 µl of test chemical-FCA emulsion; Maximum injection concentration was 2%B. CHALLENGE EXPOSURE- No. of exposures: Thrice (on three consecutive days)- Day(s) of challenge: three consecutive days- Exposure period: 3 consecutive days- Test groups: 3 - Control group: No detailed data available - Site: applied to both sides of each ear- Concentrations: 25 µl of test chemical-FCA emulsion;Topical concentrations for the chemical was selected based on solubility limit to vehicles- Evaluation (hr after challenge): the day following the last topical applicationOTHER: After the topical exposure auricular lymph nodes were excised and pooled for each experimental group. A single cell suspension of LNC was prepared by mechanical disaggregation through a sterile 200-mesh gauge and washed once with Hanks' balanced salt solution. The LNCs were resuspended in RPMI- 1640 culture medium supplemented with 25 mM N-2-hydroxyethylpiperazine-N'- 2-ethanesulphonic acid (HEPES), penicillin, streptomycin and fetal calf serum, and the total LNC number were determined using an automated cell counter. The LNC suspensions (1 x 106 cells) were seeded into 96-well culture plates (five wells per group) and cultured with 0.5 pCi [3H] methyl thymidine (3HTdR) for 24 h at 37°C in a humidified atmosphere of 5% CO, in air. Culture was terminated by a semiautomatic cell harvester, and the 3HTdR incorporation was determined by liquid scintillation counting. The increases in LNC number and 3HTdR incorporation relative to controls were derived for each experimental group and the total lymph node activation induced by the test chemicals was calculated.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: induction exposure phase
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 µl
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- non- sensitizing during sensitive mouse lymph node assay (SLNA)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: induction exposure phase. . Hours after challenge: 24.0. Group: test group. Dose level: 50 µl . No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: non- sensitizing during sensitive mouse lymph node assay (SLNA) .
- Reading:
- other: challenge exposure phase
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 µl
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- non- sensitizing during sensitive mouse lymph node assay (SLNA)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: challenge exposure phase. . Hours after challenge: 24.0. Group: test group. Dose level: 25 µl . No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: non- sensitizing during sensitive mouse lymph node assay (SLNA) .
Any other information on results incl. tables
CONCENTRATION | Vehicle |
0.25 % | Induction phase- Saline |
0.5% | Challenge exposure- DMSO |
SLNA values | |
SIn | 1.35 |
SIP | 1.15 |
SItotal | 1.55 |
DMSO = dimethylsulphoxide
SIn= stimulation index of LNC number;
SIP= stimulation index of LNC proliferation;
SItotal= stimulation index of total lymph node response.Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material, Erythrosine, is not sensitizing to the skin of BALB/c strain mice in the sensitive mouse lymph node assay (SLNA)
- Executive summary:
- Sensitive mouse lymph node assay skin sensitization assay was performed on female BALB/c strain mice. They were intradermally injected with 50 µl of test chemical –FCA emulsion into two sites of the abdominal skin at both sides of the ventral line. After 5 days 25 µl of test chemical in vehicle was applied to both sides of each ear for three consecutive days.Control mice were treated by intradermal injection of vehicle-FCA emulsion into the abdomen and then after 5 days they were exposed to vehicle alone on the ears for three consecutive days.
The increases in LNC number and3HTdR incorporation relative to controls were derived for each experimental group and expressed as SInand SIP, respectively; SI total as obtained from SInx SIP, which indicates the total lymph node activation induced by the test chemical.
A chemical was regarded as positive if it showed an SItotalvalue of 3 or more. The SItotalvalue of erythrosine was found to be 1.55 at 5% DMSO concentration.
The test material, Erythrosine, is not sensitizing to the skin of BALB/c strain mice in the sensitive mouse lymph node assay.
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