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EC number: 271-524-7 | CAS number: 68583-95-9 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 16035:1.
- 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
Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical.
In this study, the chemical applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.
Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.
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:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned data
- Principles of method if other than guideline:
- Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: Human
- Strain:
- other: Not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Day(s)/duration:
- 24 hours application for 10 alternate days
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 200 subjects
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period:24 hours
- Test groups: 200 subjects
- Control group: no data
- Site: volvar forearms
- Frequency of applications:
- Duration: 10 alternate days
- Concentrations: no data
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 14 days
- Exposure period: 24 hours
- Test groups: 200 subjects
- Control group:
- Site: scapular backs
- Concentrations: no data
- Evaluation (hr after challenge): after 24 hours - Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- No data available
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- None of the subjects showed any signs of contact sensitization.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.
Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects. - Executive summary:
Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical.
In this study, the chemical applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.
Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been reviewed to ascertain the potential of the test chemical to cause dermal sensitization in living organisms. These include in vivo experimental studies performed on guinea pigs as well as humans for the test chemical. The results are summarized as follows:
Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical.
In this study, the chemical applied to the subjects volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The colour did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period.
Therefore, the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.
This is supported by the results of a Patch test conducted to evaluate the dermal sensitization potential of the test chemical. 20% test chemical in water was applied in Finn Chambers to the skin of 15 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories 16 patients were tested with the dye. None of the patients showed any signs of sensitization. Thus the test chemical can be considered as non sensitizer to human skin.
The above results are further supported by the Draize- Shelanski Repeat Insult Patch Test performed on 200 human subjects to determine the degree of dermal sensitization caused by the test chemical.
The test chemical was applied to the subject's volvar forearms as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge treatment were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The test chemical did not produce any skin allergic reaction in the induction as well as challenge treatment.
Hence, the test chemical was considered to be not sensitizing to skin.
Based on the available in vivo results, the test chemical indeed lacks the potential to cause sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations to the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available in vivo results, the test chemical indeed lacks the potential to cause sensitization to skin. Hence, the test chemical can be considered to be not sensitizing to skin. Comparing the above annotations to the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.
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