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EC number: 701-362-9 | CAS number: -
Eye irritation
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:
- 2 001
- 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
- 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
Constituent 1
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.
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