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EC number: 276-374-6 | CAS number: 72139-17-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 276-374-6
- EC Name:
- Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 72139-17-4
- Molecular formula:
- C25H16ClF2N5O8S2.2Na
- IUPAC Name:
- disodium 1-amino-4-({3-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-methyl-5-sulfophenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Blue 114
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippischen Versuchstierzucht, Hagemann GmbH & Co. KG, 4923 Extertal 1
- Weight at study initiation: 2.6 kg (mean)
- Housing: one animal per cage
- Diet (e.g. ad libitum): ad libitum ("mümmel z" (ssniff / Soest))
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment, 100 µL of the test item was placed into the lower lid ofthe right eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
- Observation period (in vivo):
- 1, 24, 48, 72, 96 h and 8 d
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: according to Draize (see Table 1 in box "Any other information on material and methods")
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- no indication of irritation
- Remarks:
- partly blue staining of cornea area
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- All symptoms were fully reversible within 8 days. Cornea scores could only be obtained for a few time points due to blue staining of the eye. For individual results see Table 2 in box "Any other information on results icl. tables"
Any other information on results incl. tables
Table 2: Individual results of the eye irritation test
Animal number | Endpoint | Draize score | |||||
1 h | 24 h | 48 h | 72 h | 8 d | mean (24/48/72 h) | ||
1 | Cornea | x | x | x | 0 | 0 | x |
Iris | 0 | 0 | 0 | 0 | 0 | 0.0 | |
Conjuntivae | x | 1 | 1 | 0 | 0 | 0.7 | |
Chemosis | 2 | 2 | 1 | 1 | 0 | 1.3 | |
2 | Cornea | x | x | x | x | 0 | x |
Iris | 0 | 0 | 0 | 0 | 0 | 0.0 | |
Conjuntivae | 2 | 1 | 1 | 0 | 0 | 0.7 | |
Chemosis | 2 | 1 | 0 | 0 | 0 | 0.3 | |
3 | Cornea | x | x | 0 | 0 | 0 | x |
Iris | 0 | 0 | 0 | 0 | 0 | 0.0 | |
Conjuntivae | x | 1 | 1 | 1 | 0 | 1.0 | |
Chemosis | 2 | 1 | 1 | 1 | 0 | 1.0 |
x: not scored/calculated, due to strong blue staininig of the eye
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute eye irritation/corrosion study conducted according to OECD 405, the test substance causes no serious irritant effects on the rabbit eye. Only slight effects in the conjunctivae were observed at 24 and 48 h but fully reversible within 72 h. Initially found slight chemosis effects were fully reversible within 8 d.
- Executive summary:
In a primary eye irritation study conducted according to OECD 405, 0.1 mL of the undiluted test item was instilled into the conjunctival sac of one eye of 3 male New Zealand White rabbits. The untreated eye served as control. No washing was performed after instillation. Animals were then observed for 8 days. Eyes were examined at 1, 24, 48, and 72 and 192 hours after instillation. Irritation was scored by the method of Draize. Animals showed only weak signs of irritation during the first 72 h of the observation period. Determination of the cornea score was only partly possible due to blue staining of the treated eyes. All symptoms were fully reversible within 8 days.
In this study, the test material is not an eye irritant and therefore does not warrant for classification according to CLP criteria.
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