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disodium 5-{4-chloro-6-[N-ethyl-3-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[(4-vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; reaction mass of: trisodium 5-{4-chloro-6-[N-ethyl-(3-(2-sulfonatooxy)ethylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 5-{4-chloro-6-[N-ethyl-3-(2-(sulfonatooxy)ethylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-3-[4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo]-4-hydroxynaphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[N-ethyl-3-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
EC number: 444-050-5 | 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:
- May 14, 2002 - July 16, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- July 31, 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 444-050-5
- EC Name:
- -
- IUPAC Name:
- dodecasodium 5-({4-chloro-6-[ethyl({3-[2-(sulfooxy)ethanesulfonyl]phenyl})amino]-1,3,5-triazin-2-yl}amino)-3-[(E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate 5-({4-chloro-6-[ethyl({3-[2-(sulfooxy)ethanesulfonyl]phenyl})amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate 5-[(4-chloro-6-{[3-(ethenesulfonyl)phenyl](ethyl)amino}-1,3,5-triazin-2-yl)amino]-3-[(E)-2-[4-(ethenesulfonyl)phenyl]diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate 5-[(4-chloro-6-{[3-(ethenesulfonyl)phenyl](ethyl)amino}-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]naphthalene-2,7-disulfonate
- Test material form:
- solid
- Details on test material:
- Identity: Red Rwa 4565
Appearance: Solid, red powder
Storage: at room temperature at about 20°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation (at start of treatment): 11 weeks for male (animal #40) and 11 and 15 weeks for females (animal #41 and #42)
- Weight at study initiation (first day of acclimatization): 2150 g (male #40), 2110 g (female #41) and 2013 g (female #42)
- Housing: lndividually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks (batch no. 0203, Provimi Kliba AG) were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad tibitum (batch no.25102) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis are archived at RCC Ltd, ltingen.
- Water (e.g. ad libitum): Community tap water from FÜllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, ltingen.
- Acclimation period:Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other:
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g/eye
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 21 days as the treated eyes were not rinsed after instillation
- Observation period (in vivo):
- 21 days after application
- Number of animals or in vitro replicates:
- 3 (male #40, females #41 & #42)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: not relevant
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92l69lEEC, July31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7, 10,14,17 and 21 days after application.
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-41 53 Reinach/Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #40, #41 & #42
- Time point:
- other: 1h, 24h, 48h, 72h, 7d, 10d, 14d, 17d, 21d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant as scores remain nul
- Irritation parameter:
- other: Area of Corneal Opacity
- Basis:
- animal: #40, #41 & #42
- Time point:
- other: 1h, 24h, 48h, 72h, 7d, 10d, 14d, 17d, 21d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: Not relevant as scores remain nul
- Irritation parameter:
- iris score
- Basis:
- animal: #40, #41 & #42
- Time point:
- other: 1h, 24h, 48h, 72h, 7d, 10d, 14d, 17d, 21d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not relevant as scores remain nul
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #40
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #40
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #41
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #42
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #42
- Time point:
- other: 48/72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #42
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- IRRITATION
Application of the test item to healthy rabbit conjunctivae resulted in a primary eye irritation score of 1.11.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.
The individual mean score for corneal opacity and iris was 0.00 for all three animals.
The individual mean scores for the conjunctivae were 0.33, 0.33 and 1.33 for reddening and 0.33, 0.33 and 0.67 for chemosis, respectively.
No abnormal findings were observed in the cornea or iris of any animal at any of the measuring intervals.
Assessment of reddening of the conjunctivae was not possible in any animal at the 1-hour examination due to the presence of staining in the eye and/or conjunctival sac. Slight to moderate reddening was, however, noted in all animals 24 hours after treatment and slight reddening continued to be observed in one animal up to the 72 hour examination.. Obvious swelling with partial eversion of lids or swelling with lids about half closed was apparent in all animals 1 hour after treatment. Slight swelling was observed in all animals at the 24hour examination and again in one animal at the 48 hour examination.
Full assessment of the sclerae was also prevented at the 1 hour examination due to ocular staining. Slight reddening of the sclerae was however subsequently observed in all animals during the observation period.
Discharge with moistening of the lids and hairs just adjacent to the lids was evident in all animals 1 hour after treatment. lncreased ocular discharge was similarly observed in one animal at the 24 hour examination.
CORROSION
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- VIABILITY/MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
COLORATION
Marked red staining was present in the treated eye of all animals 1 hour after instillation of the test item. Slight staining continued to be observed in all animals during the entire observation period and was still evident at termination,21 days after treatment.
Red remnants of the test item were observed in the eye or conjunctival sac of 1 animal 1 hour after treatment.
BODY WEIGHTS
The body weights of all rabbits were considered to be within the normal range of variability. For results, please refer to section "Any other information on results incl. tables" hereafter.
Any other information on results incl. tables
Eye irritation scores - individual values
Animal number |
Sex |
Evaluation Interval* |
Corneal Opacity |
Area of Corneal Opacity |
Iris |
Conjunctivae |
Cumulative |
Sclera |
||
Redness |
Chemosis |
Score |
Mean |
|||||||
40 |
M |
1 hour |
0 |
0 |
0 |
n.a. |
2 |
2.00 |
2.33 |
n.a. |
41 |
F |
0 |
0 |
0 |
n.a. |
2 |
3.00 |
n.a. |
||
42 |
F |
0 |
0 |
0 |
n.a. |
3 |
3.00 |
n.a. |
||
40 |
M |
24 hours |
0 |
0 |
0 |
1 |
1 |
2.00 |
2.33 |
1 |
41 |
F |
0 |
0 |
0 |
1 |
1 |
2.00 |
1 |
||
42 |
F |
0 |
0 |
0 |
2 |
1 |
3.00 |
1 |
||
40 |
M |
48 hours |
0 |
0 |
0 |
0 |
0 |
0.00 |
0.67 |
0 |
41 |
F |
0 |
0 |
0 |
0 |
0 |
0.00 |
1 |
||
42 |
F |
0 |
0 |
0 |
1 |
1 |
2.00 |
1 |
||
40 |
M |
72 hours |
0 |
0 |
0 |
0 |
0 |
0.00 |
0.33 |
0 |
41 |
F |
0 |
0 |
0 |
0 |
0 |
0.00 |
0 |
||
42 |
F |
0 |
0 |
0 |
1 |
0 |
1.00 |
0 |
*Examinations were performed at the specified times after instillation of the test item
n.a.= not assessable due to staining produced by the test item
Note: Observations continued for 21 days due to staining present in the eye
At 7, 10, 14, 17, 21 days after treatment, the eye reactions for the three assessed animals consisted of grade 0.00 for corneal opacity, area of corneal opacity, iris and conjunctivae (redness and chemosis).
Evolution of body weights in grams
Body weight in grams |
||||
Animal No. |
Sex |
First day of acclimatization |
Day of treatment |
Last day of observation |
40 |
Male |
2150 |
2393 |
2922 |
41 |
Female |
2110 |
2219 |
3003 |
42 |
Female |
2013 |
2339 |
2935 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on criteria defined in Regulation (EC) No 1272/2008, RED RWa 4565 is classified as Serious eye damage (category 1). Eye irritation test shows persistence of red staining at the end of the 21 days recovery period which is according to the CLP guideline a reason for Serious eye damage Cat 1 (discoloration of the cornea by a dye substance).
- Executive summary:
The primary eye irritation potential of RED RWa 4565 was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item application. The scores of each animal at the following reading times (24, 48 and72 hours) were used in calculating the respective mean values for each type of lesion.
The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 1.11 (max. 13).
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean score for corneal opacity and iris was 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.33 and 1.33 for reddening and 0.33, 0.33 and 0.67 for chemosis, respectively.
The instillation of RED RWa 4565 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment. Where evaluation was possible, no abnormal findings were observed in the cornea or iris of any animal. No corrosion was observed at any of the measuring intervals. A marked red staining was, however, present in the treated eye of all animals t hour after instillation of the test item. Slight staining continued to be observed in all animals during the entire observation period and was still evident at termination, 21 days after treatment.
Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), due to the irreversible red staining present in the treated eyes of all animals, RED RWa 4565 is considered to be "R41-Risk of serious damage to eyes".
Based on criteria defined in Regulation (EC) No 1272/2008, RED RWa 4565 is classified as Serious eye damage (category 1). Eye irritation test shows persistence of red staining at the end of the 21 days recovery period which is according to the CLP guideline a reason for Serious eye damage Cat 1 (discoloration of the cornea by a dye substance).
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