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Toxicological information

Eye irritation

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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:
1994
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

Constituent 1
Chemical structure
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
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.