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EC number: 418-000-8 | CAS number: 163062-28-0 BLEU REN 20
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6,13-dichloro-3,10-bis-{2-[4-fluoro-6-(2-sulfo-phenylamino)-1,3,5-triazin-2-ylamino]-propylamino}-benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium, sodium salt.
- EC Number:
- 418-000-8
- EC Name:
- 6,13-dichloro-3,10-bis-{2-[4-fluoro-6-(2-sulfo-phenylamino)-1,3,5-triazin-2-ylamino]-propylamino}-benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium, sodium salt.
- Cas Number:
- 163062-28-0
- Molecular formula:
- CAS formula: C42 H34 Cl2F2 N14 O14 S4 .xLi. xNa
- IUPAC Name:
- dilithium(1+) disodium 6,13-dichloro-3,10-bis({[2-({4-fluoro-6-[(2-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)propyl]amino})-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
- Details on test material:
- - Name of test material (as cited in study report): FAT 40529/A
- Lot/batch No.: P 1/95
- Storage: Ambient conditions
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pampaloni s.d.f., Via Pontita 16, 56043 Fauglia, Pisa, Italy
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: approximately 2 kg
- Housing: Individually in stainless steel cages measuring 63 x 48 x 41 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary.
- Diet (e.g. ad libitum): Commercially available anti-biotic free pelleted laboratory diet (Altromin MSK, A. Rieper, Bolzano, Italy), ad libitum
- Water (e.g. ad libitum): Drinking water supplied to each cage via water bottles, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 7 days
- Number of animals:
- 3
- Details on study design:
- On the day of dosing a 0.5 g aliquot of the test substance was mixed to a paste with 2.5 mL of sterile water. This was spread evenly over a 2.5 x 2.5 cm. square of gauze. The gauze was placed on to the animal's skin, with the test substance in contact with the skin. This was covered by a strip of aluminium foil which was held in contact with the skin by encircling the trunk of the animal with an elastic adhesive bandage. All three rabbits of the group were treated in this manner. After four hours the bandages were removed and the treated sites gently cleaned using an absorbent material soaked in warm water.
One hour after removal of the patches and test substance the treated sites were assessed for signs of reaction to treatment. Similar examination was undertaken twenty four, forty eight and seventy two hours and seven days after the end of the four hour dosing period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Blue staining of the skin.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance has no observable irritant effect on the skin.
- Executive summary:
In a GLP compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5g) was applied to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 7 days. The test substance showed a erythema and edema grade of 0 at all observed time points. Under the conditions of this experiment, the test substance was found to be not irritating.
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