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EC number: 421-950-6 | CAS number: 187674-70-0 Y-104
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 June 1995 to 02 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
- EC Number:
- 421-950-6
- EC Name:
- Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
- Cas Number:
- 187674-70-0
- Molecular formula:
- C27H26N6Na4O13S6
- IUPAC Name:
- tetrasodium 3-{2-[4-({4,6-bis[(3-sulfonatopropyl)sulfanyl]-1,3,5-triazin-2-yl}amino)-5-methoxy-2-methylphenyl]diazen-1-yl}naphthalene-1,5-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Substance type: yellow-brown to orange powder.
- Storage condition of test material: at room temperature.
- pH: 6.6 (10 % w/w in distilled water)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.9 ± 0.2 kg
- Housing: Individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm).
- Diet: Pelleted diet ad libitum.
- Water: Filtered water ad libitum
- Acclimation period: At least 5 days.
- Animal selection: The day before treatment, the eyes of each animal were examined in order to use only animals without any signs of ocular irritation. Animals showing signs of ocular irritation, ocular defects or pre-existing corneal injury were not used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 – 70 %
- Photoperiod: 12 hour light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per animal as supplied. - Duration of treatment / exposure:
- A single exposure was performed.
- Observation period (in vivo):
- Animals were observed for 72 hours post application.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- APPLICATION
- Method: The test material in its original form was placed into the conjunctival sac of the left eye of the 3 animals after gently pulling the lower lid away from the eyeball. The lower and upper lids were held together for about one second to avoid any loss of the test material. The right eye remained untreated as a control.
REMOVAL OF TEST SUBSTANCE
- Washing: Not performed.
SCORING SYSTEM: The eye was examined approximately 1 hour after administration and then at 24, 48 and 72 hours. The ocular reaction was scored according to the Draize scale, see Table 1. Any other lesions observed were noted.
TOOL USED TO ASSESS SCORE: Direct corneal examination was performed, if necessary with an Ultra Violet lamp. 1 or 2 drops of 0.5 % sodium fluorescein solution was used to determine the presence or absence of corneal opacification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #1
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #2
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #3
- Time point:
- other: Mean of observation at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- An orange colouration of the conjunctiva was noted 1 hour after treatment only, in all animals; redness of conjunctiva was marked by this colouration.
In one animal a slight (grade 1) corneal opacity was noted at the 24 hour reading only.
No other ocular lesions were observed during the study.
Any other information on results incl. tables
Table 2: Ocular Response
Rabbit No. |
Region of Eye |
Description of Ocular Reactions |
Scores |
Mean Irritation Score |
|||
1 hr |
24 hrs |
48 hrs |
72 hrs |
||||
01 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
Redness |
C |
0 |
0 |
0 |
0.0 |
||
Discharge |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal Opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
|
* |
* |
* |
* |
|
|
Fluorescein |
|
/ |
U |
/ |
/ |
|
|
02 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
Redness |
C |
0 |
0 |
0 |
0.0 |
||
Discharge |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal Opacity |
Intensity |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
|
* |
* |
* |
* |
|
|
Fluorescein |
|
/ |
U |
/ |
/ |
||
03 |
Conjunctivae |
Chemosis |
0 |
0 |
0 |
0 |
0.0 |
Redness |
C |
0 |
0 |
0 |
0.0 |
||
Discharge |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Corneal Opacity |
Intensity |
0 |
1 |
0 |
0 |
0.3 |
|
Area |
0 |
2 |
0 |
0 |
0.7 |
||
Other |
|
* |
* |
* |
* |
|
|
Fluorescein |
|
/ |
U |
/ |
/ |
|
Mean score calculated from readings taken at 24, 48 and 72 hours.
* = None
C = Scoring masked by orange colouration
U = Fluorescein used
/ = Fluorescein not used
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material was determined to be non-irritating, since a classifiable reaction was not observed in any of the treated rabbits.
- Executive summary:
The acute eye irritation of the test material was determined in vivo in a study conducted under GLP conditions and in accordance with the standardised guidelines OECD 405 and EU method B.5.
Three male New Zealand White rabbits were exposed to 100 mg of the test material in a single ocular application. Ocular irritation was assessed 1 hour after application and then at 24, 48 and 72 hours, according to the Draize scale. Any other lesions were noted.
An orange colouration of the conjunctiva was noted 1 hour after treatment only, in all animals; redness of conjunctiva was obscured by this colouration. In one animal a slight (grade 1) corneal opacity was noted at the 24 hour reading only. No other ocular lesions were observed during the study.
Under the conditions of the test, the test material is considered to be a non-irritant since none of the animals displayed a reaction strong enough to trigger classification.
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