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EC number: 233-117-2 | CAS number: 10039-33-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- October 18th to October 25th 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Procedure similar to the proposed guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978
- Deviations:
- yes
- Remarks:
- the procedure was based upon the guideline but was not in every part identical.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the animals were not evaluated 60 minutes after exposure and the observation period lasted only 7 days.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- EC Number:
- 268-500-3
- EC Name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Cas Number:
- 68109-88-6
- Molecular formula:
- C28H48O8Sn
- IUPAC Name:
- Ethyl-9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf.
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water: ad libitum.
- Acclimation period: 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C.
- Humidity: 55 ± 15 %.
- Air changes: Approximately 15 per hour.
- Photoperiod: 12 hours light per day.
IN-LIFE DATES: from: 18 October 1982 to: 25 October 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Volume: 0.1 ml.
- Duration of treatment / exposure:
- After insertion of the test material into the conjunctival sac, the eyelids were gently closed for 15 seconds.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 9; 6 male and 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 of the 9 rabbits the eye was flushed with 10 ml of sterile physiological saline
- Time after start of exposure: approximately 30 seconds after treatment.
SCORING SYSTEM:
- Eyes were scored according to the Draize scale (1977)
Conjunctivae
A-Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3
B-Chemosis
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 more than half closed 4
C-Dicharge
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 a considerable area around the eye 3
Total score = (A + B + C) x 2; Maximum Total = 20
Iris -D
Normal 0
Folds above normal, congestion, swelling, circumcorneal 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, haemorrhage, gross destruction (any or all of these) 2
Total score = D x 5; Maximum Total = 10Cornea Grade
E - Degree of Opacity (most dense are used)
No opacity 0
Scattered or diffuse areas of opacity details of iris clearly visible 1
Easily discernible translucent area; details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea 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
Maximum Total Score Possible = 110
TOOL USED TO ASSESS SCORE: slit-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: M1, M2, M3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- animal: F1, F2, F3, M4, M5, M6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: M1, M2, M3, F1, F2, M4, M5, M6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: F3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: M1, M2, M3, F2, M4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: M5
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: rinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: F1, M6
- Time point:
- 24/48 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed and unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: F3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritant / corrosive response data:
- The test material was found to cause moderate irritation.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Table: individual Irritation Scores at 24, 48, 72 hours and days 4 and 7
| Unrinsed | Rinsed | |||||||||||
| Observation Time | Observation | M1 | M2 | M3 | F1 | F2 | F3 | Average | M4 | M5 | M6 | Average |
| 24 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | 3 | 3 | 3 | 3.0 | |
| Chemosis | 3 | 3 | 3 | 3 | 3 | 2 | 2.8 | 3 | 2 | 3 | 2.7 | |
| 48 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 3 | 3 | 3 | 2 | 2.8 | 3 | 3 | 3 | 3.0 | |
| Chemosis | 3 | 3 | 3 | 3 | 3 | 1 | 2.7 | 3 | 3 | 3 | 3.0 | |
| 72 hrs | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 1 | 1 | 0 | 0 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 3 | 3 | 3 | 3 | 3.0 | 3 | 3 | 3 | 3.0 | |
| Chemosis | 3 | 3 | 3 | 2 | 3 | 3 | 2.8 | 3 | 2 | 2 | 2.3 | |
| 4 days | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 0 | 1 | 0 | 1 | 0 | 0.5 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 3 | 3 | 2 | 3 | 3 | 3 | 2.8 | 2 | 2 | 2 | 2.0 | |
| Chemosis | 2 | 2 | 2 | 2 | 2 | 3 | 2.2 | 2 | 2 | 2 | 2.0 | |
| 7 days | Opacity | 1 | 1 | 1 | 1 | 1 | 1 | 1.0 | 1 | 1 | 1 | 1.0 |
| Iris | 1 | 0 | 1 | 0 | 0 | 0 | 0.3 | 0 | 0 | 0 | 0.0 | |
| Conjunctivae | 2 | 1 | 2 | 2 | 2 | 1 | 1.7 | 1 | 2 | 1 | 1.3 | |
| Chemosis | 2 | 1 | 2 | 2 | 2 | 1 | 1.7 | 1 | 1 | 1 | 1.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: classified as an eye irritant according to the CLP Regulation (EC) No. 1272/2008
- Conclusions:
- The substance is considered to be an eye irritant.
- Executive summary:
The eye irritancy potential of the test material was assessed in a GLP compliant in vivo study that was based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978. Nine New Zealand White rabbits were exposed to the test material; the treated eye of three animals was rinsed with saline 30 seconds after exposure. The reactions to the test material were evaluated in accordance with the Draize scale after 24, 48 and 72 hours followed by further observations after 4 and 7 days.
The scores obtained for the unrinsed eyes were: cornea opacity = 1 for all animals, iris =1 (M1, M2, M3); iris =0 (F1, F2, F23), conjuctivae redness =3 (M1 -M3, F1-2); redness = 2.67 (F3), chemosis = 3 for all animals. The scores obtained for the rinsed eyes were: cornea opacity = 1, iris =0 and conjuctivae redness =3 for all animals, chemosis = 3 (M4), =2.33 (M5) = 2.67 (M6). The irritation observations were not reversible within the 7 days of observation period, however, a decrease of the irritation score was noted for conjuctivae redness and chemosis.
The substance is considered to be an eye irritant.
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