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EC number: 202-268-6 | CAS number: 93-69-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Animal testing pre-dates availablity of valid in-vitro methods
Full data set not seen, but conclusions demonstrate eye irritation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-o-tolylbiguanide
- EC Number:
- 202-268-6
- EC Name:
- 1-o-tolylbiguanide
- Cas Number:
- 93-69-6
- Molecular formula:
- C9H13N5
- IUPAC Name:
- 1-o-tolylbiguanide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5-2.0 Kg
- Housing: metal cages
- Diet (e.g. ad libitum): ad libitum access to standard rabbit food - NAFAG, Gossau SG
- Water (e.g. ad libitum): ad ibitum
- Acclimation period: 8 days
- Only rabbits with normal ophthalmic findings were used for these tests.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/-1°C
- Humidity (%): 55+/-5%
- Photoperiod (hrs dark / hrs light): 14 hours light, 10 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye was not treated and served as an untreated control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g - Duration of treatment / exposure:
- In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water.
- Observation period (in vivo):
- The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the
treated eye was flushed with 10 ml of lukewarm water.
SCORING SYSTEM:
Score for eye irritation in rabbits (Table 1)
CORNEA:
A: Opacity and degree of density (most dense area scored)
-No opacity 0
-Scattered or diffuse area, details of iris clearly visible 1
-Easily discernible translucent areas, details of iris slightly obscured 2
-Opalescent areas, no details of iris visible, size of pupil barely discernible 3
-Opaque, iris invisible 4
B: Area of cornea involved
-One quarter (or less) but not zero 1
-Greater than one quarter, but less than half 2
-Greater than half, but less than three quarters 3
-Greater than three quarters, up to whole area 4
A x B x 5 Maximum possible score = 80
IRIS:
A: Values
Normal 0
Folds above normal, congestion, swelling, circumcornea injection (any or 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
A x 5 Maximum possible score = 10
CONJUNCTIVAE:
A: Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
B: Cheraosis
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 half closed to completely closed 4
C: 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
(A + B + C) x 2 Maximum possible score = 20
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 15.6
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 80
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 10.6
- Max. score:
- 20
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 10.6
- Max. score:
- 20
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Full data set not seen, but conclusions demonstrate eye irritation
Any other information on results incl. tables
The total maximum score was thus 80 for the cornea, 10 for the iris, 20 for the conjunctivae and 110 for the entire eye. The severity of overall eye irritation was rated as:
0 -10 minimal
11 -25 slight
26 -56 moderate
57 -84 marked
above 84 extreme
Results - Tables 2 and 3
In the present experiments the irritation index was established as 20 for the cornea, 1.8 for the iris and 7.8 for the conjunctivae. The substance causes therefore a moderate overall eye irritation.
Table 2 Eye irritation in individual rabbits with eyes rinsed 30 seconds after treatment
| Days after appl. | Rabbit 1 ♀ | Rabbit 2 ♀ | Rabbit 3 ♀ | ||||||
| Cornea | Iris | Conjunct. | Cornea | Iris | Conjunct. | Cornea | Iris | Conjunct. | |
| 1 | 15 | 0 | 10 | 10 | 0 | 10 | 0 | 0 | 0 |
| 2 | 10 | 0 | 10 | 10 | 0 | 8 | 0 | 0 | 0 |
| 3 | 10 | 0 | 8 | 15 | 0 | 8 | 0 | 0 | 0 |
| 4 | 10 | 0 | 8 | 15 | 0 | 8 | 0 | 0 | 0 |
| 7 | 5 | 0 | 8 | 5 | 0 | 6 | 0 | 0 | 0 |
Table 3 Eye irritation in individual rabbits with eyes not rinsed after treatment
| Days after appl. | Rabbit 4 ♂ | Rabbit 5 ♂ | Rabbit 6 ♂ | ||||||
| Cornea | Iris | Conjunct. | Cornea | Iris | Conjunct. | Cornea | Iris | Conjunct. | |
| 1 | 5 | 0 | 12 | 30 | 0 | 14 | 60 | 10 | 12 |
| 2 | 5 | 0 | 12 | 30 | 0 | 14 | 60 | 10 | 12 |
| 3 | 5 | 0 | 8 | 30 | 0 | 12 | 60 | 10 | 10 |
| 4 | 5 | 0 | 6 | 30 | 5 | 10 | 60 | 10 | 10 |
| 7 | 5 | 0 | 0 | 30 | 5 | 10 | 80 | 10 | 10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Conclusions:
- moderately irritating
Animal testing pre-dates availablity of valid in-vitro methods
Full data set not seen, but conclusions demonstrate eye irritation
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