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EC number: 700-610-3 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 405), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- IUPAC Name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- Reference substance name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- EC Number:
- 700-610-3
- Molecular formula:
- UVCB substance - not applicable
- IUPAC Name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- Details on test material:
- - Name of test material : Sepisol Fast Blue 2BR
- Physical state/ appearance: blue powder
- Lot/batch No.: 905536
- Storage condition of test material: ambient temperature and in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage GRIMAUD, (49450 Roussay, FRANCE)
- Weight at study initiation: 2.660 kg the day of the test material application
- Housing: Singly housed, in suspended stainless steel cage (60cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe (EVIALIS, 37018 Tours, France)
- Water : ad libitum, distributed by a polypropylene biberon with a stainless steel teat.
- Acclimation period: 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/1 2 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the animal serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,1 g - Duration of treatment / exposure:
- single exposure followed by contention period of one hour
- Observation period (in vivo):
- 15 days
- Number of animals or in vitro replicates:
- 1 animal.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No removal by washing.
SCORING SYSTEM: according to OECD 405 .
TOOL USED TO ASSESS SCORE: direct visualization with white light and examination with fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean score: 24,48 and 72h after application
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: D15
- Remarks on result:
- other: For ethical reasons, the study was stopped on D16 instead of D21.
- Irritation parameter:
- other: Redness
- Basis:
- animal #1
- Time point:
- other: mean score: 24,48 and 72h after application
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: D15
- Remarks on result:
- other: For ethical reasons, the study was stopped on D16 instead of D21.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean score: 24h, 48 and 72 h after application
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: D15
- Remarks on result:
- other: For ethical reasons, the study was stopped on D16 instead of D21.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean score: 24h, 48h, 72h after application
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: D15
- Remarks on result:
- other: For ethical reasons, the study was stopped on D16 instead of D21.
- Irritant / corrosive response data:
- The test item leads to a non-reversible irritation
Any other information on results incl. tables
SCORE
Chemosis:
Animal N° |
Observation Period (after application) |
||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 to Day 15 |
Day 16 |
|
2855 |
3 |
4 |
4 |
4 |
4.0 |
4 |
End of the study |
Redness :
Animal N° |
Observation Period (after application) |
|||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 to Day 9 |
Day 10 to Day 15 |
Day 16 |
|
2855 |
3 |
3 |
3 |
3 |
3.0 |
• |
•• |
End of the study |
Iris :
Animal N° |
Observation Period (after application) |
|||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 to Day 9 |
Day 10 to Day 15 |
Day 16 |
|
2855 |
1 |
2 |
2 |
1 |
1.7 |
1 |
•• |
End of the study |
Cornée :
Animal N° |
Observation Period (after application) |
|||||||
1h |
24h |
48h |
72h |
Mean* |
Day 5 to Day 10 |
Day 11 to Day 15 |
Day 16 |
|
2855 |
0 |
3 |
3 |
2 |
2.7 |
2 |
•• |
End of the study |
*Mean score 24h, 48h, 72h after removal of the patch
•Increase of the dark-blue coloration, red invaluable
•• Graduation impossible
Clinical observations:
Time Reading |
Comments |
Animal #1 |
|
Day 1 (first hour) |
Nothing to report |
Day 2 up to day 8 |
Presence of a small amount of product in the conjunctival sac - Edematous and burned nictitating membrane - Opacity visible to the naked eye -Alopecia. |
Day 9 up to Day 14 |
Presence of a small amount of product in the conjunctival sac - Edematous and burned nictitating membrane - Opacity visible to the naked eye -Alopecia - Glued eyes - Pus. |
Day 15 up to Day 21 |
Eyes totally glued – End of the study by sacrifice of the animal for ethical reasons. |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the test item is classified as irritant category 1 according to the CLP regulation (EC 1272/2008).
- Executive summary:
The aim of this study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance of the effects after single application of 0.1 g of the pure test material named Sepisol Fast Blue 2BR as supplied on eye in one rabbit. The assay was
performed according to the OEDC guideline n° 405.
Ocular reactions (redness and chemosis of conjunctivae, iris and cornea lesions) were scored 1h, 24h, 48h and 72 h after application and until D15. The untreated eye served as control.
The results for the mean score were as follows (mean score 24h, 48h and 72h after application): chemosis: 4.0; redness: 3.0; Iris:1.7 and Cornea: 2.7.
In regards of the results observed and the irreversibility and the seriouness of the lesions, the study was ended at D15 for ethical reasons. Likewise she was not carried out on 2 other rabbits.
According to the criteria defined in the CLP regulation (EC 1272/2008), the test material is found to be classified as eye damage category 1.
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