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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
Endpoint summary
Administrative data
Description of key information
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Principles of method if other than guideline:
- The sensitization potential of D&C Red 33 was determined by performing patch test on humans.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- human
- Sex:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- No. of animals per dose:
- 59 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
- Reading:
- other:
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 4
- Total no. in group:
- 59
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 4.0. Total no. in groups: 59.0.
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The sensitization potential of D&C Red 33 was determined by performing patch tests on humans.59 patients were tested with the dye. 4 patients with ‘?+ ‘results and 2 patients with ‘++ ‘ results were reported.This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.
- Executive summary:
The sensitization potential of D&C Red 33 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
59 patients were tested with the dye.4 patients with ‘?+ ‘ results and 2 patients with ‘++ ‘ results were reported.
This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation:
Applying weight of evidence approach to the available predicted and experimental data for the target as well as read-across chemical, the information is summarised as below
The skin sensitising potential of D&C Red No. 33 is predicted using OECD QSAR toolbox version 3.3. The ubstance D&C Red No. 33 is predicted to be not sensitising to the human skin .
A sensitization test was carried out in female guinea pigs to estimate the sensitizing potential according to the OECD guideline 406 for Acid Red 33.The maximisation test was performed in female guinea pigs. The intradermal induction of sensitisation in the test group was performed in the nuchal region with a 5% dilution of the test item in 1% CMC and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitisation was conducted for 18 hours under occlusion with the test item at 25% in 1% CMC one week after the intradermal induction and following pre-treatment of the test areas with 10% sodium-laureth-sulphate (SLS), 24 hours prior to application of the test item. 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. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.The study authors concluded that the test substance was not a skin sensitizer.
A skin sensitization test report was published by the COMMISSION OF THE EUROPEAN COMMUNITIES; Directorate-General Telecommunications, Information Industries and Innovation, 1988.A sensitization test was carried out in guinea pigs to estimate the sensitizing potential for Acid Red 33A maximimization test in guinea pig was carried out with an induction treatment by intradermal injection of a 5% aqueous solution and by tropical application of 10% aqueous solution. The challenge was made by topical application of 10% and 5% for 2 weeks later. There were no positive reactions. It appeared in this test that 10% in distilled water was not irritating to guinea pig skin. Hence it was considered that the chemical substanceAcid Red 33was not sensitizing to skin after challenge exposure.
A sensitization test of D&C Red 33 was determined by performing patch test on humans was conducted by Guin JD. 2003. 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 . 59 patients were tested with the dye.4 patients with ‘?+ ‘ results and 2 patients with ‘++ ‘ results were reported.
This sensitizing potential of D&C Red 33 can be considered ambiguous, since the final results were unable to accurately estimate the sensitizing potential of the test chemical.
On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not sensitising to the skin, in accordance with the CLP criteria.
Migrated from Short description of key information:
The skin sensitising potential of D&C Red No. 33 is predicted using OECD QSAR toolbox version 3.3. The ubstance D&C Red No. 33 is predicted to be not sensitising to the human skin .
Justification for selection of skin sensitisation endpoint:
The skin sensitising potential of D&C Red No. 33 is predicted using OECD QSAR toolbox version 3.3. The ubstance D&C Red No. 33 is predicted to be not sensitising to the human skin .
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
On the basis of available information for the target as well as read across substance and applying weight of evidence approach, the test substance can be considered as not sensitising to the skin, in accordance with the CLP criteria.
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