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Mixture of hexa(sodium,lithium) 4-{[1,7-disulfonato-5-hydroxy-6-({4-[(6-methoxy-5-sulfonatobenzoheteromonocycle-2-yl)diazenyl]-5-alkyl-2-(3-sulfonatopropoxy)phenyl}diazenyl)naphthalen-2-yl]diazenyl}-5-hydroxy-1-(4-sulfonatophenyl)heteromonocycle-3-carboxylate and hexa(sodium,lithium) 4-{[1,7-disulfonato-5-hydroxy-6-({4-[(6-methoxy-7-sulfonatobenzoheteromonocycle-2-yl)diazenyl]-5-alkyl-2-(3-sulfonatopropoxy)phenyl}diazenyl)naphthalen-2-yl]diazenyl}-5-hydroxy-1-(4-sulfonatophenyl)heteromonocycle-3-carboxylate
EC number: - | CAS number: -
- 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:
- January 20 - February 17, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to current OECD test guidelines and GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): E-BK105
- Physical state: Black powder, solid
- Lot/batch No.: MB-1
- Expiration date of the lot/batch: Five years from shipment day (November 4, 2010)
- Storage condition of test material: Room temperature, in an air tight container in a dark place
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc. (Hino breeding center)
- Age at study initiation: 7 week old males and 10 week old females
- Weight at study initiation: 228.9 to 245.4 g for males and 211.6 to 243.4 g for females
- Fasting period before study: not applicable
- Housing: Stainless steel cages (WxDxH: 226x346x198mm), stainless steel cage racks and feeders, one animal per cage
- Diet (ad libitum): Autoclave-sterilised pellet diet (CRF-1, Oriental Yeast Co., Ltd.). Each lot has been analysed: contaminants confirmed to within acceptable limits established by the testing facility.
- Water (ad libitum): Well water admixed with NaClO (about 2 ppm). Analysed twice a year: contaminants confirmed to be within acceptable limits established by the testing facility.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.9-23.8
- Humidity (%): 48.4-57.0
- Air changes (per hr): 10 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 4 x 5 cm
- % coverage: within 10% of total body surface
- Type of wrap: After hair clipping animals were fitted with a neck collar. The test substance was applied on a lint cloth lined with an impermeable sheet (Blenderm, 3M Health Care). This was covered with an elastic adhesive bandage (SILKYTEX white No.5, Alcare Co. Ltd.)
REMOVAL OF TEST SUBSTANCE
- Washing: wiped with a gauze sheet immersed in lukewarm water and water was removed with dry tissue paper. Animals were fitted with neck collars during dosing and recovery period.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Required amount, calculated based on body weight on day of dosing. The lint cloth, where the substance was applied to, was moistened with an appropriate amount of water (1 ml). - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for their mortality and clinical signs before the dosing and at 30 min, 1, 3 and 6 hours postdose on the day of dosing (Day 1) and once daily for 14 days thereafter. All animals were subjected to body weight measurement before the dosing (Day 1) and on Days 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occured in either sex.
- Clinical signs:
- other: No substance related changes were seen in clinical signs.
- Gross pathology:
- No abnormalities were seen in either sex.
- Other findings:
- No skin irritaion was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of E-BK105 in rats was considered to be more than 2000 mg/kg bw under the conditions of this study (OECD 402).
- Executive summary:
E-BK105 was administered once percutaneously to five male and five female Crl:CD(SD) rats at a dose of 2000 mg/kg bw to evaluate its acute dermal toxicity in accordance with OECD test guideline 402. The dose was applied for 24 hours occlusively after which the application site was wiped. As a result, no death occurred in either sex and no test substance related change was seen in clinical signs, body weight or necropsy. Therefore, the LD50 value of E-BK105 in rats is considered to be more than 2000 mg/kg bw under the conditions of this study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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