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EC number: 242-355-6 | CAS number: 18472-87-2
- 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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
The sensitization potential of D&C Red 28 was determined by performing patch tests on humans.9 patients were tested with the dye. No reactions were reported by all the patients. Thus, according to the CLP classification criteria the substance 3,4,5,6-tetrachloro-2-(1,4,5,8 -tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (D&C Red 28) can be considered as a non- sensitizer in humans.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed journal
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The sensitization potential of D&C Red 28 was determined by performing patch test on humans.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Specific details on test material used for the study:
- Name of test material (as cited in study report): D&C Red 28 also known as Phloxine B
Molecular formula: C20H4Br4Cl4O5.2Na
Molecular weight: 829.6388 g/mol
Substance type: Organic
Physical state: Solid - Species:
- other: Humans
- Strain:
- other: Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in Petrolatum
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 2% in Petrolatum
- No. of animals per dose:
- 9 patients
- Details on study design:
- OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.The reactions of the patients were graded as ?+. + and ++ categories.
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- non sensitising
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The sensitization potential of D&C Red 28 was determined by performing patch tests on humans.9 patients were tested with the dye. No reactions were reported by all the patients. Thus, according to the CLP classification criteria the substance 3,4,5,6-tetrachloro-2-(1,4,5,8 -tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (D&C Red 28) can be considered as a non- sensitizer in humans.
- Executive summary:
The sensitization potential of D&C Red 28 was determined by performing patch tests on humans.
The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.
9 patients were tested with the dye. No reactions were reported by all the patients.
The substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (D&C Red 28) can be considered as a non- sensitizer in humans.
The CLP classification for the test chemical is ‘Not Classified’.
Reference
Table 1: Patch test results
Chemical |
No of patients tested |
?+ |
+ |
++ |
D&C Red 28 (1% in pet.) |
9 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation:
Various studies has been investigated for the test chemical 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS Number: 18472-87-2) to observe the potential for skin sensitization to a greater or lesser extent along with the study available on structurally similar read across substance Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate (Erythrosine) (CAS No. 16423-68-0). The studies are summarized as below:
The sensitization potential of D&C Red 28 was determined by performing patch tests on humans.
The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories.
9 patients were tested with the dye. No reactions were reported by all the patients.
The substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (D&C Red 28) can be considered as a non- sensitizer in humans.
The CLP classification for the test chemical is ‘Not Classified’.
Further, Mouse Local Lymph Node Assay (LLNA) was performed to evaluate the skin sensitizing potential of the test substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (Acid Red 92) (CAS No. 18472-87-2) on female CBA/J mouse.
Acid Red 92 was tested in different concentrations (0.5, 1.5, 3.0, 7.0 % (w/v)) in DMSO (vehicle). On days 0, 1 and 2 the animal received 25 μl of the test item formulation, positive control or vehicle on the dorsal surface of each pinnae. Each dose was tested on one animal group, which consisted of 5 animals.
Morbidity/mortality checks were performed twice daily. Clinical examinations were performed daily. Individual body weights were recorded on days - 1 and 5. All animals were sacrificed on day 5 for assessment of cell proliferation.
No mortality was observed during the study. There were no treatment-related clinical signs. There were no treatment-related effects on body weight or body weight gains. The positive control (p-phenylenediamine) induced a positive response, as it elicited at least a 3 -fold increase in isotope incorporation relative to the vehicle. The mean stimulation index was 3.9 at the concentration of 1%.
The test substance induced a negative response, as it did not elicit at least a 3-fold increase in isotope incorporation relative to the vehicle. The mean stimulation indices were 0.9, 1.3, 1.5 and 1.9 at the concentrations of 0.5 %, 1.5%, 3.0% and 7.0%, respectively.
Based on these results, the test substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (Acid Red 92) (CAS No. 18472-87-2) is not a skin sensitizer under the defined experimental conditions. The experimental conditions used in this study have been stricter than use conditions. Thus, according to CLP criteria it is therefore concluded that 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (Acid Red 92) (CAS No. 18472-87-2) does not pose a sensitizing risk to consumers when used as intended.
Hence, based on the above mentioned studies for target substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS Number: 18472-87-2), no skin reactions indicative of sensitisation were found. Thus, it infers that 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS Number: 18472-87-2) is not classified as skin snsitiser as per CLP regulation.
Justification for classification or non-classification
According to Regulation (EC) 1272/2008 and based on the human and animal studies, it is concluded that the substance 3,4,5,6-tetrachloro-2- (1,4,5,8 -tetra bromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS Number: 18472-87-2) is not classified as skin sensitizer.
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