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EC number: 846-153-4 | CAS number: 653592-41-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2006 - January 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Methods for the Determination of Toxicity (1992)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Guideline for the Testing of
Chemicals (2002)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- Health Effects Test Guidelines (1998)
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethyl 3-[(benzenesulfonyl)oxy]-1-(3-chloropyridin-2-yl)-4,5-dihydro-1H-pyrazole-5-carboxylate
- EC Number:
- 846-153-4
- Cas Number:
- 653592-41-7
- Molecular formula:
- C17H16ClN3O5S
- IUPAC Name:
- ethyl 3-[(benzenesulfonyl)oxy]-1-(3-chloropyridin-2-yl)-4,5-dihydro-1H-pyrazole-5-carboxylate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 3275–3451g
- Housing: Animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards
- Diet: PMI Nutrition International, LLC Certified Rodent LabDiet (#5322), approximately 125 g daily
- Water: Tap water, ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16–22
- Humidity (%): 30–70
- Air changes (per hr): Not recorded
- Photoperiod (hrs dark / hrs light): Alternating 12-hour light and dark cycles
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: The left eye of each rabbit was not treated with the test substance and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 75 or 79 mg of test material - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 1, 24, 48, and 72 hours after dosing
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: The conjunctiva, iris, and cornea of each treated eye were evaluated for evidence of irritation approximately 1, 24, 48, and 72 hours following administration of the test substance using the Draize scale.
TOOL USED TO ASSESS SCORE: At each observation period, eyes were examined using illumination and magnification. Fluorescein stain examinations were conducted at the 24-hour and each subsequent evaluation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test substance produced conjunctival redness (score of 1 or 2) in two rabbits, conjunctival chemosis (score of 1 or 2) in three rabbits, and discharge (score of 2 or 3) in two rabbits. Signs of irritation completely resolved in the rabbits by 24, 48, or 72 hours. There were no test substance-related body weight effects or clinical signs noted.
Any other information on results incl. tables
Table 1: Individual rabbit ocular irritation scores
| Reading | Number # | Rabbit number | Cornea | Iritis | Conjunctiva | Fluorescein Stain | |||
| Opacity | Area | Redness | Chemosis | Discharge | |||||
| 1 hour | 1 | 308 | 0 | 0 | 0 | 0 | 1 | 0 | na |
| 2 | 298 | 0 | 0 | 0 | 1 | 1 | 2 | na | |
| 3 | 299 | 0 | 0 | 0 | 2 | 2 | 3 | na | |
| 24 hours | 1 | 308 | 0 | 0 | 0 | 0 | 0 | 0 | neg |
| 2 | 298 | 0 | 0 | 0 | 1 | 0 | 0 | neg | |
| 3 | 299 | 0 | 0 | 0 | 1 | 0 | 0 | neg | |
| 48 hours | 1 | 308 | 0 | 0 | 0 | 0 | 0 | 0 | neg |
| 2 | 298 | 0 | 0 | 0 | 0 | 0 | 0 | neg | |
| 3 | 299 | 0 | 0 | 0 | 1 | 0 | 0 | neg | |
| 72 hours | 1 | 308 | 0 | 0 | 0 | 0 | 0 | 0 | neg |
| 2 | 298 | 0 | 0 | 0 | 0 | 0 | 0 | neg | |
| 3 | 299 | 0 | 0 | 0 | 0 | 0 | 0 | neg | |
Table 2: Mean scores for ocular responses for individual rabbits
| Number # | Rabbit number | Corneal opacity | Iritis | Conjunctival redness | Conjunctival chemosis |
| 1 | 308 | 0 | 0 | 0 | 0 |
| 2 | 298 | 0 | 0 | 0.33 | 0 |
| 3 | 299 | 0 | 0 | 0.67 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
- Executive summary:
The potential of the test item to induce eye irritation was assessed according to the OECD Guidelines 405.
A single dose of approximately 75 or 79 mg (equivalent to 0.1 mL) of the test item was administered into the lower conjunctival sac of the right eye of three male young adult New Zealand White rabbits. The eyes remained unwashed after treatment. The conjunctiva, iris, and cornea of each treated eye were evaluated for evidence of irritation approximately 1, 24, 48, and 72 hours following administration of the test substance.
The test substance produced conjunctival redness (score of 1 or 2) in two rabbits, conjunctival chemosis (score of 1 or 2) in three rabbits, and discharge (score of 2 or 3) in two rabbits. Signs of irritation completely resolved in the rabbits by 24, 48, or 72 hours. Based on the mean degree of eye irritation observed at 24 to 72 hours, classification is not required.
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