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EC number: 310-133-9 | CAS number: 69997-91-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 July 2015 - 19 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A valid Bühler test is avalaible, therefore no further LLNA is required.
Test material
- Reference substance name:
- Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
- EC Number:
- 310-133-9
- EC Name:
- Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
- Cas Number:
- 69997-91-7
- Molecular formula:
- C36H32CrN8O8S2.1/2C6H16N2.H
- IUPAC Name:
- Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
- Details on test material:
- - Physical state: Solid / red
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: HARLAN (Kreuzelweg 53, 5961 NM HORST The Netherlands)
- Age at study initiation: 3 or 4 weeks
- Weight at study initiation: ca 273g (average)
- Housing: in groups of 2 in polycarbonate containers
- Diet: SAFE 106, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 40%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 40%
- No. of animals per dose:
- 20 in test group and 10 in control group
- Details on study design:
- RANGE FINDING TESTS:
Three guinea pigs were treated with the test item placed onto the selected treatment sites and covered with an occlusive dressing for a period of 6 hours at 4 different concentrations: diluted at 40%, 30%, 20% and 10% in propylene glycol. The animals treated at the concentrations of 40%, 30%, 20% and 10% received 0.5 mL of the corresponding preparation. Washing of the skin after removal of the dressing was done with propylene glycol. A macroscopic evaluation of the cutaneous reactions was conducted 24 and 48 hours after removal of the occlusive dressings. The skin reaction was observed and recorded. 24 and 48 hours after removal of the patches, no cutaneous reaction was noted at all tested concentrations. In view of these results, the concentration selected was 40% for the 3 inductions of the main study and the concentration selected was 40% for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three applications, on day 0, day 6 and day 13
- Test groups: 20 females
- Control group: 10 females, 0.5 mL of propylene glycol
- Site: scapular zone
- Duration: 6 hours
- Concentrations: 40%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after the last induction
- Exposure duration: 6 hours
- Test groups: 0.5 mL of the test item at 40% in propylene glycol on the left flank and 0.5 mL of propylene glycol on the right flank
- Control group: 0.5 mL of the test item at 40% in propylene glycol on the left flank and 0.5 mL of propylene glycol on the right flank
- Site: dorso-lumbar zone, on either side of the spine
- Concentrations: 40%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the occlusive dressing - Positive control substance(s):
- yes
- Remarks:
- The results of the 3 last positive groups (Reference substance: a-Hexylcinnamaldehyde CAS n° 101-86-0 - Tests n°17-19) carried out as method sensibility, are presented in the report.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
- Induction phase
No cutaneous reaction was recorded during the induction phase in the treated group. Red discoloration of the application area was noted after patch removal, but the staining did not prevent the assessment of erythema. No cutaneous reaction was recorded during the induction phase in the control group.
- Challenge phase:
In the treatment group (treatment concentration of 40%), no macroscopic cutaneous reactions attributable to allergy were observed during the examination following the removal of the occlusive dressing. Red discoloration of the application area was noted after patch removal, but the staining did not prevent the assessment of erythema. In the control group (associated with the treatment concentration of 40%), no cutaneous intolerance reaction was observed during the examination following the removal of the occlusive dressing. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with propylene glycol.
- Weight evolution
No abnormalities and no differences in the body weight between the control and the treated group were observed.
- Mortality
No mortality was registered during the main test.
- Clinical signs
No abnormal clinical signs related to the administration of the test item were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of these results, under these experimental conditions, the test item is not a skin sensitiser.
- Executive summary:
The aim of the study was to evaluate the possible allergenic activity of the test item after topical administration in guinea pigs. The induction phase was conducted with three topical applications of the test item diluted at 40% (w/w) in propylene glycol to 20 guinea-pigs with occlusive dressing and a 13-day rest phase. The challenge phase, conducted under an occlusive dressing for 6 hours, consisted of a single topical application of the test item at 40% and an application of a negative control (propylene glycol). The concentration selected for the induction phase and the challenge based on the result of a pre-test. Readings were performed 24 and 48 hours after removal of the patches. In the treatment group (treatment concentration of 40%), no macroscopic cutaneous reactions attributable to allergy were observed during the examination following the removal of the occlusive dressing. In the control group (associated with the treatment concentration of 40%), no cutaneous intolerance reaction was observed during the examination following the removal of the occlusive dressing. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with propylene glycol. In conclusion, in view of these results, under these experimental conditions, the test item is not a skin sensitiser.
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