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EC number: 422-940-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 15 November 1996 to 6 March 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD Guideline 405 (adopted 1987) without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 16.06.1994
Test material
- Reference substance name:
- -
- EC Number:
- 422-940-4
- EC Name:
- -
- Cas Number:
- 155633-54-8
- Molecular formula:
- C24H39N3O3Si3
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4-methyl-6-[2-methyl-3-(2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptan-4-yl)propyl]phenol
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): G4375
- Physical state: whitish solid
- Analytical purity: 98% minimum
- Impurities (identity and concentrations): Methanol (<100 ppm) and Isopropanol (<100 ppm)
- Purity test date: certificate of analysis 20/10/1995
- Lot/batch No.: DEF/C 95003/B
- Expiration date of the lot/batch: No data
- Stability under test conditions: Stable under storage condition.
- Storage condition of test material: In the original container at room temperature away from direct sunlight.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White Rabbit - CRL:KBL(NZW)BR
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Stolzenseeweg 32-36, D-88353 Kisslegg
- Age at study initiation: 15 weeks
- Weight at study initiation: male : 3.0 kg bw; females: 2.7-3.1 kg bw
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet (e.g. ad libitum): Pelleted standar Kliba 341, Batch 91-95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), available ad libitum.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 40-70 %- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h light
IN-LIFE DATES: From: From 15 November 1995 To: 23 November 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 g
- The test article was ground in a mill and applied undiluted. - Duration of treatment / exposure:
- Eyes of the animals were not rinsed.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Grading of ocular lesions as described in OECD test guideline 405.
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel, Switzerland)
Other: When present, corrosion and /or staining of sclera and cornea by the test article were recorded and reported.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritant / corrosive response data:
- The test item showed a primary irritation score of 1.11 when applied to the conjunctival sac of the rabbit eye, with a full reversibility at 72 hours.
- Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.The body weight gain of all animals was within the normal range of variability. No staining of the cornea was observed at any of the reading times.
Any other information on results incl. tables
Table 7.3.2/1: Results of eye irritation for each animal at each observation time
Rabbit Nº |
Time |
Opacity (/4) |
Iritis (/2) |
Conjunctival redness (/3) |
Chemosis (/4) |
1 |
1h |
0 |
0 |
2 |
2 |
24h |
0 |
0 |
2 |
1 |
|
48h |
0 |
0 |
1 |
0 |
|
72h |
0 |
0 |
0 |
0 |
|
2 |
1h |
0 |
0 |
2 |
2 |
24h |
0 |
0 |
2 |
1 |
|
48h |
0 |
0 |
1 |
0 |
|
72h |
0 |
0 |
0 |
0 |
|
3 |
1h |
0 |
0 |
2 |
2 |
24h |
0 |
0 |
1 |
0 |
|
48h |
0 |
0 |
1 |
0 |
|
72h |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Silatrizole (encoded "G4375") induced slight irritations being reversible within 72 hours. Therefore the test material is not classified as irritant to the eyes according to the Regulation (EC) N° 1272-2008 (CLP) and according to the Directive 67/548/EEC.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 (1987 version) and in compliance with GLP, 3 healthy rabbits of the New Zealand White strain (1 male and 2 females) were exposed to 0.1 g of undiluted test item Silatrizole (encoded "G4375"), previously ground in a mill, in their left eye while the right eye remained untreated and served as control. The treated eye of the animals was left unrinsed. The eyes were examined and the changes in the cornea, iris and conjunctivae (redness and chemosis) were observed at 1, 24, 48 and 72 h.
Slight signs of ocular irritation were observed at 1h, 24h and 48h. All ocular reactions reverted after 72 hours. In this study, Silatrizole is a slight eye irritant in rabbits.
Under the test conditions, Silatrizole is not classified as irritant to the eyes according to the Regulation (EC) N° 1272-2008 (CLP).
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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