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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:
From December 12 to 16, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no certificate of analysis of the test substance; systemic adverse effects not followed
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated
EC Number:
701-362-9
Molecular formula:
(C2 H4 O)x (C2 H4 O)y C21 H20 O4
IUPAC Name:
Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated
Details on test material:
SID Change
Previous CAS: 64401-02-1
Previous EC: 613-584-2

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits of the stock Chbb:HM (SPF) - Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, Biberach, Germany
- Weight: 2.8-2.9 kg
- Housing: Housed individually in PPO cages
- Diet: Pelleted complete rabbit diet "Altromin 2123", ad libitum
- Water: Domestic quality drinking water (acidified with hydrochloric acid to pH 2.5), ad libitum
- Acclimation period: Approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 20 ± 3 °C
- Humidity: 55 ± 15 %
- Air changes: 10 times/h
- Photoperiod: 12 h dark / 12 h light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: After the first 24 h reading fluorescein was instilled and eyes were examined for ocular lesions. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage.

SCORING SYSTEM: Draize (1977) scoring system

TOOL USED TO ASSESS SCORE: Eyes of the animals were examined with a hand held inspection lamp fitted with white and UV -light and magnifying glass with 2 X magnifications. The examination was performed before and after instillation of fluorescein.

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:
iris score
Basis:
animal #1
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:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis 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:
iris score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean individual score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
One hour after application of the test article, animals showed conjunctival redness, chemosis and discharge different from normal. All the eyes were normal one day after instillation.
Other effects:
No

Any other information on results incl. tables

- The study was initiated with one rabbit (animal no. 1889). Since no marked eye irritation was seen in this animal another two rabbits were included in the study with time difference.

Table 1: Scores for ocular lesions

 

Rabbit No./

Weight per kg

 

1 h

 

24 h

 

48 h

72 h

Individual mean score*

 

 

 

F

1889 / 2.9

Cornea opacity, degree

 

0

0

0

0

0

0.00

Cornea opacity, area

 

0

0

0

0

0

 

Iris

 

0

0

 

0

0

0.00

Conjunctiva

 

Redness

 

1

0

 

0

0

0.00

Chemosis

 

0

0

 

0

0

0.00

Discharge

 

0

0

 

0

0

 

1895 / 2.8

Cornea opacity, degree

 

0

0

0

0

0

0.00

Cornea opacity, area

 

0

0

0

0

0

 

Iris

 

0

0

 

0

0

0.00

Conjunctiva

 

Redness

 

1

0

 

0

0

0.00

Chemosis

 

1

0

 

0

0

0.00

Discharge

 

0

0

 

0

0

 

1896 / 2.8

Cornea opacity, degree

 

0

0

0

0

0

0.00

Cornea opacity, area

 

0

0

0

0

0

 

Iris

 

0

0

 

0

0

0.00

Conjunctiva

 

Redness

 

1

0

 

0

0

0.00

Chemosis

 

1

0

 

0

0

0.00

Discharge

 

1

0

 

0

0

 

 

F - Reading after instillation of fluorescein

 

* Only the scores from the readings after 24, 48 and 72 h are included in the calculation of the individual mean scores

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, Bisphenol A ethoxylate diacrylate is not classified as irritating to eyes.
Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy female albino rabbits of the stock Chbb:HM (SPF) – Littlerussian were exposed to 0.1 mL of Bisphenol A ethoxylate diacrylate in one eye, while the contralateral eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined 1 h and 24 h after instillation. After the first 24 h reading fluorescein was instilled and eyes were examined for ocular lesions. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV -light to detect possible corneal damage. The eyes were also examined 48 and 72 h after the treatment. Draize (1977) scoring system was followed to grade the ocular reactions. 

One hour after application of the test article, animals showed conjunctival redness, chemosis and discharge different from normal. All the eyes were normal one day after instillation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 0, 0, 0 for conjunctivae score and 0, 0, 0 for chemosis score. In this study, Bisphenol A ethoxylate diacrylate is not an eye irritant on female rabbits.

 

Under the test conditions, Bisphenol A ethoxylate diacrylate is not classified as irritating to eyes.