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Toxicological information

Eye irritation

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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:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
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.