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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)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 to 31 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 10 weeks
- Weight at study initiation: 1869 to 2064 g
- Housing: Aluminium cages (W318xH358xD498) with stainless steel cascade racks, one animal per cage.
- Diet (ad libitum): Pellet diet (LRC4, Oriental Yeast Co., Ltd.), each lot was analysed: contaminants were confirmed to be within acceptable limits of the testing facility
- Water (ad libitum): Well water admixed with sodium hypochlorite (about 0.2 ppm). Analysed every 6 months: contaminants were 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 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Once dosed, the treated eye was left unwashed in three animals, while in three other animals about 30 seconds after administration the treated eye was washed.
- Observation period (in vivo):
- 1, 24, 48, 72 and 96 hours after administration
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of 6 animals, the eye was washed with about 20 ml/eye of distilled water for 30 seconds at a flow rate not damaging to the eye.
- Time after start of exposure: 30 sec.
SCORING SYSTEM: Draize evaluation criteria (acc to OECD 405), Kay & Calandra's ocular irritation evaluation criteria.
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein: at observations 24 hours after administration, the treated eye was observed first by a slit lamp. One drop of fluorescein sodium solution prepared with Japanese pharmacopoeia water for injection to 2 w/v% was then instilled into the cornea and 2-3 seconds later the cornea was washed with about 20 ml of distilled water. The presence or absence of any injury in the cornea was examined again by a slit lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score in unwashed and washed eyes.
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Score in unwashed and washed eyes.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, chemosis and discharge
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: 24 , 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Score in unwashed and washed eyes. Max. score with chemosis is 4.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: eye unwashed animals
- Time point:
- other: 1 hr
- Score:
- 4.7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: In eye washed animals the score was 4.0 indicating no effect of washing.
- Irritant / corrosive response data:
- Conjunctival redness and chemosis of score 1 were observed in all animals and discharge of score 1 was observed in one animals of eye unwashed animals at 1 hour after administration. These changes disappeared by 24 hours after administration in all animals. In eye washed animals, conjunctival redness of score 1 was observed in all animals, chemosis of score 1 was observed in two animals, and discharge of score 1 was observed in one animal at 1 hour after administration. These changes disappeared by 24 hours after administration in all animals. Maximum mean total score (MMTS according to Kay & Calandra)) for unwashed and washed eyes was 8 and 7.3, respectively. 24 hours after administration and onward, pigmentation of conjunctiva and partial cornea considered to be test substance related was noted in all animals. The pigmentation in the partial cornea disappeared by 96 hours after administration.
- Other effects:
- No clinical signs or abnormal body weight gain was observed in any animal throughout the observation period. Observation of the cornea using fluorescein sodium solution revealed no stain spot in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- E-BK105 had a minimal irritation potential to the rabbit eye under the conditions of this study (OECD 405): irritation was observed only after 1 hr and fully reversible within 24 hours.
- Executive summary:
The acute eye irritation or corrosion potential of E-BK105 was assessed in six (3 eye unwashed and 3 eye washed animals) male New Zealand White rabbits (3 eye unwashed and 3 eye washed animals). The test substance was instilled into the right eye of
the animal at 0.1 g. As a result, conjunctival redness and chemosis of score 1 were observed in all animals and discharge of score 1 was observed in one animal of an eye unwashed animal at 1 hour after administration. These changes were fully reversible within 24 hours. In the eye washed animals conjunctival redness of score 1 was observed in all animals, chemosis of score 1 was observed in two animals, and discharge of score 1 was observed in one animal at 1 hour after administration. These effects were also fully reversible within 24 hours. The MMTS of the eye unwashed and washed animals was 4.7 and 4.0, respectively, showing no effect of the eye washing. In conclusion, E-BK105 had minimal eye irritation potential to the rabbit eye 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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