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EC number: 260-350-7 | CAS number: 56706-10-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From19 Feb 1996 to 1 Mar 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- EC Number:
- 260-350-7
- EC Name:
- 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- Cas Number:
- 56706-10-6
- Molecular formula:
- C18H42O6S2Si2
- IUPAC Name:
- 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- Reference substance name:
- S2
- IUPAC Name:
- S2
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, GERMANY
- Age at study initiation: 24, 60 months (males); 20 months (female)
- Weight at study initiation: 2.41-2.55 kg (male); 2.76 kg (female)
- Housing: 1/cage
- Diet (e.g. ad libitum): standard diet, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-20.0
- Humidity (%): 50-84
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: Not stated
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: none required - other eye used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit) 0.1 ml
- Concentration (if solution): neat - Duration of treatment / exposure:
- No washout (examinations: 1, 24, 48, 72 h)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (2 males, 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing reported
SCORING SYSTEM: Draize 1944, 1994; OECD 404
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: 'pencil light'
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- irritation index
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Irritation index 2/110 was deemed in this study to indicate no irritation (Gilman et al. 1983).
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The test material did not cause significant ocular lesions, in two or more animals, as indicated by any of the following:
corneal opacity =>2...<3
iris lesion =>1...=<1.5
conjunctival redness =>2.5
conjunctival oedema (chemosis) =>2
based, in each case, on mean values for each animal derived from readings at 24, 48 and 72 h.
(EU criteria).
There were no irridial or corneal effects.
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae redness |
Conjunctival chemosis |
Conjunctivae discharge |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max score 3 |
|
60 min |
0,0,0 |
0,0,0 |
1,1,1 |
1,1,0 |
2,2,2 |
24 h |
0,0,0 |
0,0,0 |
0,1,1 |
0,0,0 |
0,0,0 |
48 h |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
72 h |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
Average 24h, 48h, 72h |
0 |
0 |
0.2 |
0 |
0 |
Area effected |
0 |
- |
- |
- |
- |
Maximum average score (including area affected, max 110; 24, 48, 72 h) |
0/80 [corneal opacity x area x 5] |
0/10 [iris score x 5] |
0.4/20 [(redness + chemosis + discharge) x 2]
|
||
Reversibility*) |
n/a |
n/a |
c |
c |
c |
Average time (unit) for reversion |
- |
- |
48 h |
24 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Gilman, M. R., Jackson E. M., Cervernm, D. R., Moreno, M. T. (1983). Relationship between the primary dermal irritation index and ocular irritation. J. Toxicol-Cut & Ocular Toxicol; 2: 107-117.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A reliable study conducted in accordance with the standard guideline and GLP found the test material to be not irritating to the eyes of rabbits.
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