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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:
- From April 15, 2016 to June 01, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- trilithium(1+) trisodium 1-amino-4-{[3-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate 1-amino-4-{[3-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Molecular formula:
- Not applicable; this UVCB substance contains: C32H23ClN7O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 834.0 < MW < 882.1 g/mol (UVCB substance), C38H28N8O14S4.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 976.6 < MW < 1040.8 g/mol (UVCB substnace), and traces of NaCl and Na2SO4.
- IUPAC Name:
- trilithium(1+) trisodium 1-amino-4-{[3-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate 1-amino-4-{[3-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfonatophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: the animal health research institute, council of agriculture, executive yuan
- Age at study initiation: 4-5 months
- Weight at study initiation: 2946-3750 g
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12-hrs dark / 12-hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 1 hr
- Observation period (in vivo):
- 1 hr, 24 hr, 48 hr, 72 hr, 7 day and 14 day
- Number of animals or in vitro replicates:
- three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- mean of 2 higher reacted ones
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 day
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- mean of 2 higher reacted ones
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- mean of 2 higher reacted ones
- Time point:
- 24/48/72 h
- Score:
- 2.35
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- mean of 2 higher reacted ones
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of weak irritation
Any other information on results incl. tables
Table 1. Individual Body Weights and Clinical Observations
Animal ID |
Body weight (g) |
Body weight change (g) |
Clinical observation |
|
D1 |
D4 |
D4-D1 |
||
7 |
3750 |
3772 |
22 |
Normal |
8 |
2966 |
2876 |
-90 |
Normal |
9 |
2946 |
2888 |
-58 |
Normal |
Table 2. Eye Irritation Scores at Observation Point on Treated Eye
Animal ID |
7 |
8 |
9 |
|||||||||||||||||
Score on each observation point |
||||||||||||||||||||
1 hr |
24 hr |
48 hr |
72 hr |
7 day |
1 hr |
24 hr |
48 hr |
72 hr |
7 day |
14 day |
1 hr |
24 hr |
48 hr |
72 hr |
7 day |
|||||
Cornea |
||||||||||||||||||||
Degree of density |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
1 |
1 |
0 |
0 |
1 |
2 |
2 |
1 |
0 |
||||
Area1of opacity |
0 |
0 |
0 |
0 |
0 |
3 |
3 |
1 |
1 |
0 |
0 |
3 |
2 |
1 |
1 |
0 |
||||
Iris |
0 |
02 |
02 |
02 |
02 |
0 |
12 |
02 |
02 |
02 |
02 |
0 |
12 |
02 |
02 |
02 |
||||
Conjunctive |
||||||||||||||||||||
Redness |
0 |
2 |
1 |
2 |
0 |
2 |
3 |
3 |
3 |
1 |
0 |
2 |
2 |
1 |
2 |
0 |
||||
Chemosis |
2 |
1 |
0 |
0 |
0 |
3 |
2 |
2 |
1 |
0 |
0 |
3 |
2 |
1 |
1 |
0 |
1: Score 1: 1/4 (or less) not zero; Score 2: greater than 1/4 but less than 1/2; Score 3: great that 1/2, but less than 3/4; Score 4: greater than 3/4, up to whole area.
2: Iris discoloration
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- According to OECD 405 test method, CJ304 showed that a positive irritant to the eye and reversible. Therefore, CJ304 was categorized as irritant to eye (Category 2) based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65315009-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012).There were no effects on mortality.Slight body weight decreased was observed but all animals were clinically normal. Grade 2 corneal opacity in over 50% of area, grade 1 hyperemia of iris and grade 3 diffused redness and eversion of conjunctiva were observed in rabbits during 72 h after dosing.Until D14, all eye irritation effects were not observed. Moreover, iris discoloration was observed.CJ304 was given by a single ocular application at 100 mg amount to NZW male rabbits and followed by ocular examination and clinical observation for 14 days. Reversible corneal opacity, hyperemia of iris, and conjunctiva redness and chemosis were observed within 14 days.On the basis of the test results given above, the response of the test articlewas judged as a positive irritant to the eye.
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