Registration Dossier
Registration Dossier
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EC number: 241-677-4 | CAS number: 17689-77-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- March 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Viscous silicon preparation with ca. 5% mixture of triactoxyethylsilane and triacetoxymethylsilane.
- IUPAC Name:
- Viscous silicon preparation with ca. 5% mixture of triactoxyethylsilane and triacetoxymethylsilane.
- Details on test material:
- The study sponsor has indicated that the test material was a silicone material with ca. 5% mixture of triactoxyethylsilane + triacetoxymethylsilane.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna (UK) Ltd, Cambs, UK.
- Age at study initiation: adults
- Weight at study initiation: no data
- Housing: 1 per type III Drahtkäfige-high
- Diet: standard diet (SsniffK 4) ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/ 12h
IN-LIFE DATES: no details
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye acted as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed at 24h with physiological saline
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE:
fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: 3 animals
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: 3 animals
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: 3 animals
- Time point:
- other: 24, 48, 72h
- Score:
- >= 0.7 - <= 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 7 days
- Irritation parameter:
- chemosis score
- Basis:
- other: 3 animals
- Time point:
- other: 24, 48, 72h
- Score:
- 0 - <= 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72h
- Irritant / corrosive response data:
- Conjunctival redness (grade 1 or 2) was reported in all animals at 24 and 48h and in one animal at 72h. Chemosis (grade 1) occurred in 1 animal at 24 and 48h. Conjunctival discharge occurred in 2 animals at 1h.
Any other information on results incl. tables
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 |
Conjunctivae-chemosis |
Conjunctivae- discharge |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score 3 |
|
1 h |
0/0/0 |
0/0/0 |
3/2/3 |
1/0/2 |
0/1/1 |
24 h |
0/0/0 |
0/0/0 |
1/1/2 |
0/0/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
1/1/2 |
0/0/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
0/0/0 |
7 days |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0.7/0.7/1.7 |
0/0/0.7 |
0/0/0 |
Reversibility* |
n/a |
n/a |
c |
c |
c |
Maximum for reversion |
n/a |
n/a |
Day 7 |
72 h |
24 h |
* Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A generally reliable study, conducted according to OECD 405 but without GLP, reported mild, transient irritation to the eyes of rabbits that was entirely reversed after 7 days.
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