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EC number: 940-448-2 | 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-10-24 to 2013-12-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD/EU guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Version / remarks:
- 08 December 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tris(9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-9H-xanthen-9-ylium) 6-[(3-sulfonatonaphthalen-2-yl)methyl]-3-[(6-sulfonatonaphthalen-2-yl)methyl]naphthalene-2-sulfonate
- EC Number:
- 940-448-2
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- tris(9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-9H-xanthen-9-ylium) 6-[(3-sulfonatonaphthalen-2-yl)methyl]-3-[(6-sulfonatonaphthalen-2-yl)methyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- other: Isolated chicken eye from ROSS 308 and COBB 500
- Strain:
- other: Isolated chicken eye from ROSS 308 and COBB 500
- Details on test animals or tissues and environmental conditions:
- not appliable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The three positive control eyes were treated with Imidazole (30 mg) solution and one negative control eye was treated with NaCl (9 g/L saline) solution.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 mg - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- The control and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Minor variations within ± 5 minutes were considered acceptable.
The cornea thickness and cornea opacity were measured at all time points. Fluorescein retention was measured on two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse. - Number of animals or in vitro replicates:
- Three test item treated eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The cornea surface was rinsed thoroughly with 20 mL saline solution at ambient temperature
- Time after start of exposure: 10 seconds
TOOL USED TO ASSESS EYE CORROSION: corneal opacity, swelling, fluorescein retention, morphological effects and histopathology
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Maximum corneal swelling
- Basis:
- mean
- Time point:
- other: at up to 75 min
- Remarks on result:
- other: 4 % relative to control
- Irritation parameter:
- other: Maximum corneal swelling
- Basis:
- mean
- Time point:
- other: at up to 240 min
- Remarks on result:
- other: 4 % relative to control
- Irritation parameter:
- other: Maximum corneal opacity
- Basis:
- mean
- Time point:
- other: 240 min
- Remarks on result:
- other: Corneal opacity score: 0.0
- Irritation parameter:
- other: fluorescein retention
- Basis:
- mean
- Time point:
- other: 30 min
- Remarks on result:
- other: Fluorescein retention score: 2.7
- Irritant / corrosive response data:
- Based on the mean fluorescein retention value of 2.7 an ICE Class of IV was determined for this endpoint. Since values for corneal swelling and opacity showed no indication for severe eye damage (ICE Class I) fluorescein retention is assumed to be influenced by the test item stuck on the cornea surface after post-treatment rinse. In an additional experiment a possible fluorescence of the test item itself was investigated. Further three eyes were treated with the test item in the same manner as in the main study and fluorescein retention was measured without using fluorescein solution.
In the additional experiment fluorescein retention measurement revealed that the test item stuck on the cornea surface is non-fluorescent and does not directly influence fluorescein retention measurement. However retention of fluorescein solution at the test item stuck on the cornea surface was taken into consideration and might explain the high fluorescein retention in the absence of elevated values for corneal swelling and opacity. Therefore fluorescein retention parameter was assessed as not appropriate in this ICET study and is not considered in the evaluation of ocular corrosion and severe irritation potential of the test item.
Based on the data for corneal swelling and opacity the test item has no ocular corrosion and severe eye irritation potential. - Other effects:
- Histopathology
The results of measurement by ocular micrometer method revealed slight thickening of substantia propria in two test item treated eyes and slight thickening of anterior epithelium in three test item treated eyes as compared with the negative control and regarding the positive controls.
The thickness of other DOCU RED 116 treated samples regarding the substantia propria and regarding the anterior epithelium was the same as the negative control.
No thickness of other layers (subepithelial basement membrane, posterior limiting membrane, posterior epithelium) was observed in the treated or control samples.
Desquamation (focal complete loss) of anterior epithelium was observed in serious form (6-8 focal area/ specimen) in the positive control samples indicating for eye corrosion and severe irritation however no significant desquamation occurred in the DOCU RED 116 treated samples.
No other pathological lesion were detectable in the all investigated (treated and control) specimens.
In conclusion it can be stated that the test item DOCU RED 116 did not cause histologically detectable ocular corrosion and severe irritation. Corneas of positive and negative control showed the expected histological response.
Any other information on results incl. tables
Result tables
Test Item: DOCU Red 116
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
4 % |
I |
Mean maximum corneal swelling at up to 240 min |
4 % |
I |
Mean maximum corneal opacity |
0.0 |
I |
Mean fluorescein retention |
2.7 |
IV * |
Other Observations |
The test item was stuck on the cornea surface all test item treated eyes at 30 minutes after the post-treatment rinse. It cannot be removed from cornea surface by extra rinse (20 mL/eye saline solution). |
|
Overall ICE Class |
2xI, 1xIV |
Results of the additional experiment are shown in the table below.
Test Item: DOCU Red 116 (Additional Experiment)
Observation |
Value |
Mean fluorescein retention at 30 min |
0.3 |
Mean fluorescein retention at 75 min |
0.3 |
Mean fluorescein retention at 120 min |
0.3 |
Mean fluorescein retention at 180 min |
0.2 |
Mean fluorescein retention at 240 min |
0.2 |
Other Observations |
The test item was stuck on the cornea surface and cornea surface was painted by test item all eyes at 30 minutes after the post-treatment rinse. The cornea surfaces were not totally cleared, little volume of test item was stuck on the cornea surfaces at 240 min after the post-treatment rinse. |
Positive Control: Imidazole
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
15 % |
III |
Mean maximum corneal swelling at up to 240 min |
31 % |
III |
Mean maximum corneal opacity |
4.0 |
IV |
Mean fluorescein retention |
3.0 |
IV |
Other Observations |
Cornea opacity score 4 was observed in three eyes at 30 minutes after the post-treatment rinse |
|
Overall ICE Class |
1xIII, 2xIV |
Positive Control: Imidazole (Additional Experiment)
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
9 % |
II |
Mean maximum corneal swelling at up to 240 min |
21 % |
III |
Mean maximum corneal opacity |
4.0 |
IV |
Mean fluorescein retention |
3.0 |
IV |
Other Observations |
Cornea opacity score 4 was observed in three eyes at 30 minutes after the post-treatment rinse |
|
Overall ICE Class |
1xIII, 2xIV |
Negative Control: NaCl (9 g/L saline)
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
0 % |
I |
Mean maximum corneal swelling at up to 240 min |
0 % |
I |
Mean maximum corneal opacity |
0.0 |
I |
Mean fluorescein retention |
0.0 |
I |
Other Observations |
None |
|
Overall ICE Class |
3xI |
Negative Control: NaCl (9 g/L saline) (Additional Experiment)
Observation |
Value |
ICE Class |
Mean maximum corneal swelling at up to 75 min |
0 % |
I |
Mean maximum corneal swelling at up to 240 min |
0 % |
I |
Mean maximum corneal opacity |
0.0 |
I |
Mean fluorescein retention |
0.0 |
I |
Other Observations |
None |
|
Overall ICE Class |
3xI |
Applicant's summary and conclusion
- Interpretation of results:
- other: not severely eye damaging
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In this In vitro eye corrosives and severe irritants study using the Isolated Chicken Eye model with DOCU Red 116 according to OECD guideline No. 438 ocular corrosion and severe irritation potential was not observed.
- Executive summary:
The purpose of the Isolated Chicken Eye Test (ICET) was to evaluate the potential ocular corrosivity or severe irritancy of the test item DOCU Red 116 by its ability to induce toxicity in enucleated chicken eyes. The study was conducted in accordance with OECD guideline No. 438 (26 July 2013) and EU guideline B.48 (08 December 2010). The test compound was applied in a single dose onto the cornea of isolated chicken eyes in order to potentially classify the test compound as ocular corrosive and/or severe irritant. The ICET does not fully replace the in vivo rabbit eye test (OECD 405); however, the ICET is used as part of a tiered testing strategy for regulatory purposes.
The purpose of the additional experiment was to examine, whether DOCU Red 116 can cause false positive fluorescein retention.
Based on the data for corneal swelling and opacity DOCU Red 116 did not cause ocular corrosion and severe eye irritation in the enucleated chicken eyes.
However, a mean fluorescein retention value of 2.7 was observed indicating severe eye damage (ICE Class IV). Since values for corneal swelling and opacity showed no indication for severe eye damage (ICE Class I) fluorescein retention is assumed to be influenced by the test item stuck on the cornea surface after post-treatment rinse. Although DOCU Red 116 is not fluorescent itself as shown in the additional experiment retention of fluorescein solution at the test item stuck on the cornea surface was taken into consideration and might explain the high fluorescein retention in the absence of elevated values for corneal swelling and opacity.
Therefore fluorescein retention parameter was assessed as not appropriate in this ICET study and is not considered in the evaluation of ocular corrosion and severe irritation potential of the test item.
Histopathology evaluation of retained corneas was performed as an additional endpoint to further characterize the scope of the corneal damage suggested by the fluorescein retention parameter. DOCU RED 116 did not cause histologically detectable ocular corrosion and severe irritation.
Positive and negative controls showed the expected results. The experiments were considered to be valid.
Conclusion
In this in vitro eye corrosives and severe irritants study using the Isolated Chicken Eyes model with DOCU Red 116 according to OECD guideline No. 438 ocular corrosion and severe irritation potential was not observed.
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