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Diss Factsheets
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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 to 30 July 2010
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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: July 6, 2015
- Storage condition of test material: Room temperature, in a dark place
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 10 weeks
- Weight at study initiation: 2024 g to 2097 g
- Housing: Aluminium cages (W318xH358xD498) with stainless steel cascade racks, one animal per cage.
- Diet (ad libitum):Pellet diet (LRC4, Oriental yeast Co., Ltd.), analysed per lot: contaminants confirmed to be within acceptable limits of testing facility.
- Water (ad libitum): well water admixed with sodium hypochlorite (about 0.2 ppm), analysed every 6 months: contaminants confirmed to be within acceptable limits of waterworks law of Japan.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24-26.1
- Humidity (%): 50.6-73,.2
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: 0.3 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap: before applilcation, an Elizabeth collar was installed. The test substance (moistened with water) was placed on a patch (lint cloth) and placed on application area. The patch was fixed with a non-woven adhesive bandage and occluded by the adhesive elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Cleaned with absorbent cotton moisturised with lukewarm water. Then the Elizabeth collar was removed.
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to OECD 404 for erythema and eschar formation and oedema formation. In addition the Primary Irritation Index (PII) was calculated according to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: erythema and eschar formation and oedema formation
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: 1 and 48 hours
- Score:
- 0
- Max. score:
- 8
- Irritant / corrosive response data:
- All individual animals at any point in time did not show any skin irritation.
- Other effects:
- No clinical signs and no abnormal body weight gain were observed in any animal throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- E-BK105 had no irritation or corrosion potential on the rabbit skin under the conditions of this study (OECD 404).
- Executive summary:
The acute dermal irritation or corrosion potential of E-BK105 was assessed in three male New Zealand White rabbits according to OECD test guideline 404. The test substance (0.5 g) was moistened with 0.3 ml of water. As a result of the 4 -hour exposure (semi-occluded application) no skin reactions were observed in any animal at any observation time. Therefore, primary irritation index (PII) was 0 and evaluated as not irritating. In conclusion, E-BK105 has no irritation or corrosion potential to the rabbit skin under the conditions of the 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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