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EC number: 276-115-7 | CAS number: 71873-39-7
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Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- other: read acorss from suporting substance (analogue structure or surrogate)
- Adequacy of study:
- key study
- Study period:
- June from 14th to 29th, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- similar substance 1, AR336
- IUPAC Name:
- similar substance 1, AR336
Constituent 1
- Specific details on test material used for the study:
- The test material was used as supplied.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately 12 to 16 weeks old.
- Weight at study initiation: 2.74 - 2.90 kg.
- Housing: animals were individually housed in suspended metal cages.
- Diet: mains food RABMA Rabbit Diet, ad libitum.
- Water: mains drinking water, ad libitum.
- Acclimation period: minimum 5 days.
- Health check: immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Animals showing evidence of ocular Iesions were rejected and replaced.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 23 °C
- Humidity: 56 - 66 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test material, which was found to weigh approximately 65 mg
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Two males and one female
- Details on study design:
- PROCEDURE
- Proceeding: one rabbit was initially treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
- Application: test item was placed into the coniunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second irmediately after application, to prevent loss of the test material, and then released.
- Pain prevention: in order to minimise pain on application of the test material, one drop of local anaesthetic ("Ophthaine", 0.5 % proxymetacaine hydrochloride) was instilled into both eyes of animals 1 - 2 minutes before treatment.
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by use of the light source from a standard ophthalmoscope. Confirmation of corneal opacity was made by using sodium fluorescein B.P., if required.
SCORING SYSTEM
Immediately after administration of the test material, an assessment of the initial pain reaction was made.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from Draize J.H. 1959, Association of Food and Drug officials of the united states, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics".
Any other ocular effects were also noted.
Additional observations were made on days seven and fourteen to assess the reversibility of the ocular effects.
CONJUNCTIVAE
(A) Redness (refers to pelpebral 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) Chemsis
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 half closed to comèpletely 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
Diacharge with moinstening of the lids and hairs just adjacent to lids 2
Diacharge with moinstening of the lids and hairs a considerable area around the eye 3
TOTAL SCORE (A + B + C) x 2
MAXIMUM TOTAL: 20
(D) IRIS
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combination of any thereof) iris still reacting to light (slugging reaction is positive) 1
TOTAL SCORE (D) x 5
MAXIMUM TOTAL: 10
CORNEA
(E) Degree of opacity (most degree area used)
No opacity 0
Scattered or diffuse areas, 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
(F) 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
TOTAL SCORE (E x F) x 5
MAXIMUM TOTAL: 80
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal: 2/3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2/3
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Residual test material was noted around the treated eye of all animals throughout the study.
Red-coloured staining was noted in all treated eyes one hour after treatment.
Areas of diffuse corneal opacity were noted in all treated eyes one hour after treatment, at the 24, 48 and 72-hour observations and in one treated eye at the 7-day observation. Corneal opacity was confirmed using sodium fluorescein B.P. in all treated eyes one hour after treatment. Vascularisation of the cornea was noted in one treated eye at the 7-day observation.
Red-coloured staining prevented accurate evaluation of the iris in all treated eyes one hour after treatment. Iridial inflammation was noted in all treated eyes at the 24-hour observation and in two treated eyes at the 48 and 72-hour observations. No other iridial effects were noted.
Red-coloured staining prevented accurate evaluation of conjunctival redness in all treated eyes one hour after treatment slight conjunctival chemosis and severe discharge were noted in all treated eyes at this time. Moderate conjunctival irritation was noted in all treated eyes at the 24-hour observation with minimal to moderate conjunctival irritation at the 48-hour observation. Minimal coniunctival irritation was noted in two treated eyes at the 72-hour observation. The reaction increased to severe conjunctival irritation in one treated eye at the 72-hour observation with minimal coniunctival irritation at the 7-day observation.
No ocular effects were noted in two treated eyes seven days after treatment and in one treated eye fourteen days after treatment.
Any other information on results incl. tables
OVERALL SCORE
Animal | Reaction | Time After Treatment | Mean 24/48/72 hrs | |||||
1 hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy | |||
Female n. 100 | Cornea | 1FS | 1 | 1 | 1 | 0 | 0 | 1.00 |
Iris | ?s | 1 | 1 | 1 | 0 | 0 | 1.00 | |
Conjunctivae redness | ?s | 2 | 2 | 2 | 0 | 0 | 2.00 | |
Conjunctivae chemosis | 2 | 2 | 2 | 1 | 0 | 0 | 1.67 | |
Male n. 110 | Cornea | 1FS | 1 | 1 | 1 | 1V | 0 | 1.00 |
Iris | ?s | 1 | 1 | 1 | 0 | 0 | 1.00 | |
Conjunctivae redness | ?s | 2 | 2 | 3 | 1 | 0 | 2.33 | |
Conjunctivae chemosis | 2 | 2 | 2 | 2 | 1 | 0 | 2.00 | |
Female n. 113 | Cornea | 1FS | 1 | 1 | 1 | 0 | 0 | 1.00 |
Iris | ?s | 1 | 0 | 0 | 0 | 0 | 0.33 | |
Conjunctivae redness | ?s | 2 | 2 | 1 | 0 | 0 | 1.67 | |
Conjunctivae chemosis | 2 | 2 | 1 | 1 | 0 | 0 | 1.33 |
INDIVIDUAL SCORES AND INDIVIDUAL TOTAL SCORES FOR OCULAR IRRITATION
Famale N. 100
Time After Treatment | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy |
Cornea | ||||||
E: degree of Opacity | 1FS | 1 | 1 | 1 | 0 | 0 |
F: area of Opacity | 3 | 3 | 2 | 2 | 0 | 0 |
Score (E x F) x 5 | 15 | 15 | 10 | 10 | 0 | 0 |
Iris | ||||||
D | ?s | 1 | 1 | 1 | 0 | 0 |
Score (D x 5) | 0-10 | 5 | 5 | 5 | 0 | 0 |
Conjunctivae | ||||||
A: redness | ?s | 2 | 2 | 2 | 0 | 0 |
E: chemosis | 2 | 2 | 2 | 1 | 0 | 0 |
E: discharge | 3Re | 2Re | 0Re | 0Re | 0Re | 0Re |
Score (A + B + C) x 2 | 10-16 | 12 | 8 | 6 | 0 | 0 |
Total score |
25-41 | 32 | 23 | 21 | 0 | 0 |
F: due to red-coloured staining of the cornea, sodium fluorescein B.P. was used to aid confirmation of corneal opacity
S: red-coloured staining
Re: residual test material around treated eye
?s: red-coloured staining preventing accurate evaluation of ocular effect
V: vascularisation of the cornea
Male N. 110
Time After Treatment | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy |
Cornea | ||||||
E: degree of Opacity | 1FS | 1 | 1 | 1 | 1V | 0 |
F: area of Opacity | 4 | 4 | 3 | 3 | 1 | 0 |
Score (E x F) x 5 | 20 |
20 |
15 |
15 |
5 |
0 |
Iris |
||||||
D |
?s |
1 |
1 |
1 |
0 |
0 |
Score (D x 5) |
0-10 |
5 |
5 |
5 |
0 |
0 |
Conjunctivae |
||||||
A: redness |
?s |
2 |
2 |
3 |
1 |
0 |
E: chemosis |
2 |
2 |
2 |
2 |
1 |
0 |
E: discharge |
3Re |
3Re |
2Re |
3Re |
0Re |
0Re |
Score (A + B + C) x 2 |
10-16 |
14 |
12 |
16 |
4 |
0 |
Total score |
30-46 |
39 |
32 |
36 |
9 |
0 |
F: due to red-coloured staining of the cornea, sodium fluorescein B.P. was used to aid confirmation of corneal opacity
S: red-coloured staining
Re: residual test material around treated eye
?s: red-coloured staining preventing accurate evaluation of ocular effect
V: vascularisation of the cornea
Male N. 113
Time After Treatment | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 dy | 14 dy |
Cornea |
||||||
E: degree of Opacity | 1FS | 1 | 1 | 1 | 0 | 0 |
F: area of Opacity | 3 | 3 | 2 | 1 | 0 | 0 |
Score (E x F) x 5 | 15 |
15 |
10 |
5 |
0 |
0 |
Iris |
||||||
D |
?s |
1 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0-10 |
5 |
0 |
0 |
0 |
0 |
Conjunctivae |
||||||
A: redness |
?s |
2 |
2 |
1 |
0 |
0 |
E: chemosis |
2 |
2 |
1 |
1 |
0 |
0 |
E: discharge |
3Re |
2Re |
0Re |
0Re |
0Re |
0Re |
Score (A + B + C) x 2 |
10-16 |
12 |
6 |
4 |
0 |
0 |
Total score |
25 -41 |
32 |
16 |
9 |
0 |
0 |
F: due to red-coloured staining of the cornea, sodium fluorescein B.P. was used to aid confirmation of corneal opacity
S: red-coloured staining
Re: residual test material around treated eye
?s: red-coloured staining preventing accurate evaluation of ocular effect
V: vascularisation of the cornea
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye. Irrit. 2 (H319), according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Moderate irritant
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines 405. A single application of the test material to the non-irrigated eye of three rabbits produced areas of diffuse corneal opacity, iridial inflammation and moderate to severe conjunctival irritation.
Vascularisation of the cornea was confined to one treated eye. No ocular effects were noted seven or fourteen days after treatment.
The test material produced a maximum group mean score in the range of 34.3 - 42.7 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Conclusion
The mean values from gradings at 24, 48 and 72 hours were equal to 1 for corneal opacity and iritis in all rabbits, equal/higher than 2 for conjunctival redness in two out of three rabbits and lower than 2 for chemosis in two out of three rabbits; all the reactions recorded were fully reversible within 14 days.
The substance can be considered as irritating to eye and a classification in category 2 (Eye. Irrit. 2 (H319) of the CLP Regulation (EC 1272/2008) can be considered as appropriated.
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