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EC number: 277-179-9 | CAS number: 72987-16-7
- 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: J.H. DRAIZE et al.; J. Pharmacol. Exp. Therap. 82, 1944,377
- Principles of method if other than guideline:
- - Principle of test: intracutaneous application of test substance solution on guinea pigs
- Parameters analysed / observed: swelling and reddening - GLP compliance:
- yes
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- Study from 1979, predates LLNA
Test material
- Reference substance name:
- 2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt
- EC Number:
- 277-179-9
- EC Name:
- 2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt
- Cas Number:
- 72987-16-7
- Molecular formula:
- C29 H26 F N7 O11 S3 . x K . x Na C29H(26-x-y)FK(x)N7Na(y)O11S3
- IUPAC Name:
- potassium sodium 2-{[4-({4-[(4-amino-9,10-dioxo-3-sulfonato-9,10-dihydroanthracen-1-yl)amino]cyclohexyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}benzene-1,4-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas (later: Charles River, Kisslegg)
- Weight at study initiation: average 310g
- Housing: 3 animals per cage (Makrolon cage type IV)
- Diet (e.g. ad libitum): Altromin standard diet, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2°C
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: 1% Cremophor in distilled water
- Concentration / amount:
- 0.1 %
first treatment: 0.05 mL/animal
following 9 injections: 0.1 mL/animal - Day(s)/duration:
- a total of 10 injection, every monday, wednesday, and thursday - for a total of 4 weeks
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: 1% cremophor
- Concentration / amount:
- 0.1%
11th injection: 0.05 mL/animal - Day(s)/duration:
- 14 days after last induction treatment = in the 6th week / single injection
- No. of animals per dose:
- 15 animals per dose and 15 animals for control
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Vehicle: 1% Cremophor in distilled water
- Concentration: 0.1 % test item in vehicle
- Exposure period: one injection on Monday, Wednesday and Thursday in 3 consecutive weeks and on Monday of week 4
- Test groups: 1 test group: injection 1: 0.05 ml/animal; injections 2 - 10: 0.1 ml/animal;
- Control group: yes, injection of vehicle without test item in the same amount as test group
- Site: right flank, shaved
- Frequency of applications: one injection on Monday, Wednesday and Thursday in 3 consecutive weeks and on Monday of week 4
- Concentrations: injection 1:0.05 mg test item/animal injection 2 - 10: 0.1 mg test item/animal
B. CHALLENGE EXPOSURE
- No. of exposures: singel injection - injection no 11: 14 days after injection 10
- Vehicle: 1% Cremophor in distilled water
- Concentration: 0.1 % test item in vehicle
- Test groups: injection 11: 0.05 ml/animal
- Control group: yes, injection of vehicle without test item in the same amount as test group
- Site: left flank, shaved
- Concentrations: injection 11: 0.05 mg test item/animal
- Evaluation (hr after challenge): 24 hours after application
- Observation: each 24h after injection, assesment of redness and swelling, weekly weighing - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- redness and swelling corresponds to control groups
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 15
Any other information on results incl. tables
No effect on body weight gain observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of skin sensitisation were observed. The substance is not classifiable according to CLP criteria.
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