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EC number: 407-240-9 | CAS number: 159604-94-1 BLUE 10 25 964
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 24, 1990 to November 7, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 24, 1987
- Deviations:
- yes
- Remarks:
- Due to difficulties in test substance production the initial protocol was replaced by an up to date protocol , study dates were rescheduled and the test substance name was changed in 'Cartasol Blue PE 3562'.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- (2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
- EC Number:
- 407-240-9
- EC Name:
- (2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
- Cas Number:
- 159604-94-1
- Molecular formula:
- C66H88Cu2N20O10S2.C3H5O3.C2H3O2
- IUPAC Name:
- 7,7'-bis[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-{μ-4,4'-dihydroxy-1:2k2O4:O4'-3,3'-[3,3'-dihydroxy-1:2k2O3:O3'-biphenyl-bisazo-1:2(N3,N4-η:N3',N4'-η)]dinaphthalene-2-sulphonato(6-)}dicuprate(2-), mixed (1:1) acetic/lactic acid salts
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation:
males: 189 to 219 g
females: 161 to 178 g
- Housing: polycarbonate cages containing purified sawdust as bedding material
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial flourescent light / 12 hours dark per day
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- Water prepared by reverse osmosis
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
Males: 25 cm2 (5*5 cm)
Females: 18 cm2 ( 3.5*5 cm)
- Type of wrap if used: gauzed patch fixed successively to aluminium foil and flexible bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with tap-water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Concentration (if solution): 2000 mg/kg body weight
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/viability: at periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
Body weights: Days 1 (pre-administration), 8 and 15
Symptoms: At periodic intervals on the day of dosing (day 1) and once daily thereafter for 14 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- other: other: There were no signsw of ill health or behavioural changes noted during the obsrevation period.
- Body weight:
- other body weight observations
- Gross pathology:
- Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
- Other findings:
- Treated skin abnormalities: The treated skin area showed in 1 male and 1 female erythema over the first 3 to 4 days. One female was noted with a scab on day 3 only. All animals showed blue staining of the treated skin by the test substance, which had disappeared by day 12 for males and day 13 for females.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 (rat, m/f) > 2000 mg/kg body weight
- Executive summary:
The purpose of this study was to assess the toxicity of the test article when administered to rats as a single dermal dose.
The study was carried out in accordance with OECD Guideline No. 402, "Acute Dermal Toxicity' and EEC Directive 84/449/EEC, Part B. 3, "Acute Toxicity - Dermal".
The test item was administered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.
No animals died during the study.
There were no clinical signs of toxicity or behavioural changes noted during the observation period.
All animals showed body weight gain over the study period.
The treated skin area showed in 1 male and 1 female erythema over the first 3 to 4 days. One female was noted with a scab on day 3 only. All animals showed blue staining of the treated skin by the test substance, which had disappeared by day 13.
Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.
The dermal LD50 value of the test item in rats of either sex was established as exceeding 2000 mg/kg body weight.
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