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Diss Factsheets
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EC number: 288-422-3 | CAS number: 85721-12-6
- 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
Not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- QSAR estimation
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: QSAR model developed for dyes
- Justification for type of information:
- QSAR predictive models developed for dyes.
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- QSAR estimation
- Justification for non-LLNA method:
- -
- Parameter:
- other: skin sensitization
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin sensitizing
- Executive summary:
Based on QSAR estimation, no concern for skin sensitization.
- Endpoint:
- skin sensitisation, other
- Remarks:
- in vivo LLNA
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Colipa report C174
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Vehicle:
- other: DMSO, water/acetone (1:1) mixed with olive oil (4:1)
- Concentration:
- 0.5, 1, 2 and 4 %
- No. of animals per dose:
- 5 female
- Details on study design:
- 25 μl of 0 (vehicle only), 0.5, 1, 2 and 4 % (exceeding the maximal solubility in both vehicles used) of the tested substance in either DMSO or a mixture of aqua/acetone (1:1) with olive oil (4:1) were applied on three consecutive days to the surface of the ear of 5 female CBA/J mice per group.
After application, the ears were dried for about 5 minutes by means of a hair dryer. - Positive control substance(s):
- other: p-phenylenediamine at 1 % in DMSO
- Positive control results:
- The positive control (PPD, 1 % in DMSO) caused an increase in the stimulation index by a factor of 7.8.
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 0.5 % dose in DMSO
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 1 % dose in DMSO
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 2 and 4 % doses in DMSO
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 0.5 % dose in water/acetone/olive oil
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 1 % in water/acetone/olive oil
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 2 and 4 %doses in water/acetone/olive oil
- Cellular proliferation data / Observations:
- No relevant increase in the mean stimulation indices was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin sensitizer
- Executive summary:
Under the test conditions no indications was found to considered the tested substance as a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Toxnet and Jefca evaluation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize Shelansky test
- Version / remarks:
- Comparable to the original Draize HRIPT.
- Deviations:
- not specified
- Principles of method if other than guideline:
- The test employs 15 consecutive induction patches to the same site and if erythema and/or edema develops during induction the following patch should be moved to an adjacent untreated area. 2-3 weeks after the last induction a challenge patch is applied for 48 hours and scored. The induction patch responses are also noted and interpreted as evidence of cumulative irritation.
- GLP compliance:
- no
- Type of study:
- other: Draize - Shelansky
- Justification for non-LLNA method:
- Accepted method for assessment.
- Species:
- other: human
- Positive control results:
- No data
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 % aqueous solution
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin sensitizer
- Executive summary:
None of the subjects exhibited compound induced sensitization.
- Endpoint:
- skin sensitisation, other
- Remarks:
- in vivo
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Toxnet reference - Jefca Evaluation
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Human data on skin application
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Valid test on 200 humans
- Species:
- other: human
- Sex:
- not specified
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 200
- Clinical observations:
- None of the subjects exhibited compound induced sensitization
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not skin sensitizer
- Executive summary:
None of the subjects exhibited compound induced sensitization
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available results both on animals and on human, the tested substance could be considered as not skin sensitizing.
This was confirmed also by the QSAR estimation specifically developed for dyes which predict the substance as not sensitizing.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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