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EC number: 219-455-3 | CAS number: 2439-01-2
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 September 1994 - 26September 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, Guidence on Toxicology Study Data for Application of Agricultural Chemical Registration, 59 NohSan No. 4200, January 1985.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Chinomethionate
- EC Number:
- 219-455-3
- EC Name:
- Chinomethionate
- Cas Number:
- 2439-01-2
- Molecular formula:
- C10H6N2OS2
- IUPAC Name:
- 6-methyl-2H-[1,3]dithiolo[4,5-b]quinoxalin-2-one
- Test material form:
- solid: particulate/powder
- Remarks:
- Yellow powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: MILES INC, Agricultural Division, Box 4913, Hawthorn Road, Kansas City, Missouri 64120-0013
- Test substance: MORESTAN Technical
- CAS Registry No. 2439-01-2
- Appearence: Light yellow crystals
- Batch No. of test material: 203930103
- Purity: 93.1% (Purity test date not detailed)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Freezer
- Stability under test conditions: Assured for the duration of use
- Solubility and stability of the test substance in the solvent/vehicle: Assumed stable for the duration of the study
- Reactivity of the test substance with the vehicle: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Small Stock Industries, Pea Ridge, Arkansas
- Age at study initiation: 11 weeks
- Weight at study initiation: Not reported
- Housing: Individually in stainless steel cages with flat rod floors suspended over ALPHA-Dri bedding material. Bedding changes three times a week and and animals transferred to new cages every two weeks.Room disinfected once every three weeks.
- Diet: Provided with 125g of maintance diet
- Water ad libitum
- Acclimation period: Six weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -24
- Humidity (%): 40-70
- Air changes (per hr): No reported
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: To: 12 September 1994 (Experimental start) to 26 September 1994 (Experimental Ternination date)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.63 mg (weight-equavalent to 0.1 mL)
- Duration of treatment / exposure:
- 14 Days
- Observation period (in vivo):
- Each treated animal eye was evaluated at 1, 24 48 and 72 hours in accordence with the criteria for evaluation of ocular reactions. At 7 and 14 days animals were evaluated to further charactorise the time-course and reversibility of lesions.
- Number of animals or in vitro replicates:
- Six young-adult male New Zealand White rabbits
- Details on study design:
- Rabbits were examined with 24 hours of study initiation and classified as free from eye irritation and corneal or iridal injury. 63 mg (weight-equivalent to 0.1 mL) of test item was then placed in the conjunctival sac of the left eye and the eyelids held closed for approx one second. The right eye received no test item and acted as the untreated control.
No washing of the eye is reported after test substance exposure
SCORING SYSTEM (Starred (*) figures indicate positive effect)
Criteria for Evaluation of Ocular Reactions
Cornea:
Opacity - degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than a slight dulling of the normal luster), details of iris clearly visible 1*
Easily discernible translucent area, details of iris slightly obscured 2*
Nacreous area, no details of iris visible, size of pupil barely discernible 3*
Opaque cornea, iris not discernible through the opacity 4*
Iris
Normal 0
Folds markedly deepened, congestion, swelling, circumcorneal injection (any/all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive) 1*
No reaction to light, hemorrhage, gross destruction (any or all of these) 2*
Conjunctiva
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
Vessels normal 0
Some vessels definitely injected above normal 1
Diffuse, deeper crimson red, individual vessels not easily discernible 2*
Diffuse beefy red 3*
Chemosis (lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half closed 3*
Swelling with lids about closed to completely closed 4*
Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs and considerable area around the eye 3
TOOL USED TO ASSESS SCORE: Penlight to facilitate evalauation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 62
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 62
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 62
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 62
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 63
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal: 63
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 63
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 63
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 64
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: 65
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 66
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal: 66
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 66
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: 66
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: 968
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 3
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Six young-adult male New Zealand White rabbits were used to determine the potential for technical grade MORESTAN to cause primary eye irritation. Corneal and iridal irritation (grades 2 and 1, respectively) persisted in two animals to study termination. Conjunctiva! redness and chemosis (grades 1-3 and 1-4, respectively) were first observed at one hour and were present in all animals by 24 hours after dosing. These signs resolved by study termination (day 14) in five of six animals. Discharge (grades 1-3) was observed in all six animals at one hour post-dosing and was resolved in all animals by day 7 post-dosing. All positive signs of conjuctival irritation were resolved by day 14 after exposure.
Based on these results, technical grade MORESTAN was judged to be a severe irritant to the eye of the rabbit.
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