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Dodeca (lithium, sodium)-2-({4-[4-(4-{bis[alkyl-(sulfonatoalkoxy)-4-({-sulfonato-[(substituted-phenyl)diazenyl]phenyl} diazenyl)anilino]-triazin-yl}-6-[alkyl-(sulfonatoalkoxy)-4-(sulfonato--[(substituted-phenyl)diazenyl]phenyl)diazenyl)anilino]piperazin-yl)-triazin-ylamino]-alkyl-5-(sulfonatoalkoxy)phenyl}diazenyl)-5-[(sulfonatophenyl)diazenyl]benzensulfonate
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 16 - July 31, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to 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
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): E-BW102
- Physical state: Reddish brown powder
- Storage condition of test material: At room temperature, dark place
- Stability under storage conditions: No data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kbs:NZW (Healthy)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: Animals used within the study were 10 weeks old *
- Weight at study initiation: body weights were 1961 to 2127 g *.
- Housing: Individually housed in labeled aluminium cages with stainless-stell cascade racks (W318 x H358 x D498 mm).
- Diet (e.g. ad libitum): Pelleted diet (LRC4, Oriental Yeast Co., Ltd., lot 100420)
- Water (e.g. ad libitum): Free access to well water.
- Acclimatization period: 6 days from receipt.
* Animal specifications (sex, age and body weight) are specified in the attached table.
Animals without any abnormality in the cornea, iris or conjunctiva were selected.
Results of analysis for diet was provided by Oriental Yeast Co., Ltd., and the contaminants in the diet were confirmed to be within the acceptable limits established by the test facility. The water was analyzed every 6 months at Nichigo Kyushu Co., Ltd. in compliance with the water quality standard (Waterworks Law) of MHLW, Japan. The contaminants in the water were confirmed to be within the acceptable limits.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24.0 -26.1
- Humidity (%): 50.6 - 73.2
The accommodation equipment was washed with a cage washer. The animal room was swept and wiped every day with a mop soaked in disinfectant.
- Air changes (per hr): 10 to 20 times
- Photoperiod (hrs dark / hrs light): 12/12
IN LIFE DATES: From: July 27, 2010 To: July 31, 2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.1g
- Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48, 72 and 96 hours after instillation of the test substance.
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
-Washing: In the remaining 3 animals, about 30 seconds after administration, the right eye was washed with about 20 mL/eye of distilled water for 30 seconds at a flow rate not damaging the eye.
OBSERVATIONS
- Clinical observation: Observation was performed twice, before and after administration and once daily on the other days.
- Body Weight: Body weight was measured before administration and 96 hours after administration.
- Necropsy: Not performed.
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48, 72 and 96 hours after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
0: No opacity
1: Scattered or diffuse area, details of iris clearly visible
2: Easily discernible translucent areas, details of iris slightly obscured
3: Opalescent areas, no details of iris visible, size of pupil barely discernible
4: Opaque, iris invisible
Area of cornea involved:
0: No opacity area
1: One quarter (or less) but not zero
2: Greater than one quarter, but less than half
3: Greater than half, but less than three quarters
4: Greater than three quarters, up to whole area
IRIS
0: Normal
1: Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive)
2: No reaction to light, hemorrhage, gross destruction (any or all of these)
CONJUNCTIVAL IRRITATION
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris):
0: Vessels normal
1: Vessels definitely injected above normal
2: More diffuse, deeper crimson red, individual vessels not easily discernible
3: Diffuse beefy red
Chemosis:
0: No swelling
1: Any swelling above normal (includes nictitating membrane)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids about half closed to completely closed
Discharge:
0: No discharge
1: Any amount different from normal (dose not include small amount observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs, and considerable area around the eye
Eye examinations were performed using a slit lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- Unwashed animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Unwashed Animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- Unwashed Animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Unwashed Animal #1, #2 and #3
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- Unwashed animal #1, #2, #3
- Time point:
- other: 1 hr
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- conjunctivae score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- Washed animal #4, #5 and #6
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Washed animal #4, #5 and #6
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- Washed animal #4, #5 and #6
- Time point:
- other: 24, 28 and 72 hrs.
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Washed animal #4, #5 and #6
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- Washed animal #4, #5, #6
- Time point:
- other: 1 hr
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hr
- Irritant / corrosive response data:
- Conjunctival redness, chemosis and discharge of score 1 were observed in all animals of eye-unwashed animals at 1 hour after administration. These changes disappeared by 24 hours after administration in all animals.
Individual and mean eye irritation scores are specified in the attached table. - Other effects:
- Observation of the cornea using fluorescein sodium solution revealed no stain spot in any animal.
No clinical signs were observed in any animal throughout the observation period.
No abnormal body weight gain was observed in anyb 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:
- An acute eye irritation/corrosion study with E-BW102 in the rabbit (6 males/dose) was conducted according to OECD 405 and GLP guidelines. Based on these study results, E-BW102 does not have to be classified and has no obligatory labelling requirement for eye irritation according to Regulation (EC) No. 1272/2008.
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.
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