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EC number: 250-418-4 | CAS number: 30989-05-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-03-21 to 1995-03-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate
- EC Number:
- 250-418-4
- EC Name:
- Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate
- Cas Number:
- 30989-05-0
- Molecular formula:
- C21H45BO12
- IUPAC Name:
- tris{2-[2-(2-methoxyethoxy)ethoxy]ethyl} borate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Substance type: Borated Glycol Ether
- Physical state: Clear colourless liquid
- Analytical purity: 97% (calculated after titration of boric acid)
- Purity test date: Not provided
- Lot/batch No.: Partie 24, 05-Jan-1995 (stable until 05-Jul-1995); code No. LP 1941
- Expiration date of the lot/batch: 1995-07-05
- Stability under test conditions: 1995-07-05
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Chbb: NZW (SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach, Germany; SPF breed
- Age at study initiation: 3-5 monhts
- Weight at study initiation: 3.4-3.8 kg
- Housing: separate caging, arranged in battery
- Diet: ssniff K-H (V2333) ad libitum and hay (approximately 15 g daily)
- Water: from automatic dispensers ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): No data (airconditioned)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1995-03-21 to 1995-03-31
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml applied to the conjuctival sac of the left eye
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after application
At 24 and 72 hours, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes were washed out thorougly with isotonic saline approx. 37°C at 24h after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place.
- Time after start of exposure: directly
SCORING
Ocular reactions:
In addition, discharge was scored as follows:
0: No discharge
1: Any amount different from normal (does not include small amounts normally observed in inner canthus)
2: Discharge with moistening of the lids and hairs just adjacent to the lids
3: Discharge with moistening of the lids and hairs and considerable area around the eye
The mean scores at each time point and the group mean scores at 24, 48 and 72 hours were calculated.
TOOL USED TO ASSESS SCORE: 1 drop of 0.01% fluorescein sodium solution under UV at 24 and 72 hours after application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- One hour to 2 days after application the conjuctivae of the animals were hyperaemic to a diffuse, crimson color. Obvious swelling was observed one hour after application in one animal. Additionally, clear colorless discharge was observed. Three days after application all irritations were reversible. There were no ocular lesions observed by UV examination.
For further details, please refer to the tables 1 and 2.
Any other information on results incl. tables
Table(s) 1: Eye irritation testing in rabbits with results of all parameters
Animal No. |
Cornea opacity |
Mean score |
Iris changes |
Mean score |
||||||
1 hour |
1 day |
2 days |
3 days |
1 hour |
1 day |
2 days |
3 days |
|||
116 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
186 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
188 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
Animal No. |
Conjunctivae redness |
Mean score |
Chemosis of conjunctivae |
Mean score |
||||||
1 hour |
1 day |
2 days |
3 days |
1 hour |
1 day |
2 days |
3 days |
|||
116 |
1 |
1 |
0 |
0 |
0.3 |
0 |
0 |
0 |
0 |
0.0 |
186 |
2 |
2 |
1 |
0 |
1.0 |
2 |
0 |
0 |
0 |
0.0 |
188 |
1 |
1 |
1 |
0 |
0.7 |
0 |
0 |
0 |
0 |
0.0 |
Animal No. |
Conjunctivae discharge |
|||
1 hour |
1 day |
2 days |
3 days |
|
116 |
1 |
0 |
0 |
0 |
186 |
1 |
0 |
0 |
0 |
188 |
2 |
0 |
0 |
0 |
Table 2: Mean scores of the performed observation paramters
Group mean 24, 48 & 72 hours |
|
Redness |
0.7 |
Chemosis |
0.0 |
Opacity |
0.0 |
Iris |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the results of the study B-TEGME is not irritating to eyes.
- Executive summary:
In an acute eye irritation/corrosion study according to OECD 405, three New Zealand White rabbits were exposed with the test substance.
Testing of 0.1 ml applied to the left eye of undiluted B-TEGME for 24 hours and subsequent washing with isotonic saline showed redness and discharge observed initially, however this disappeared within 3 days after dosing.
The substance was not irritating to the eyes after the exposure and the relevant observation time points.
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