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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 June 02 to 12, 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no certificate of analysis
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 6 weeks (at least)
- Weight at study initiation: 1.0 kg (at least)
- Housing: Housed individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Pelleted diet (K-H from SSNIFF® Spezialdiaten GmbH, Soest, Germany), 100 g/day; hay (TecniLab-BMI BV, Someren, The Netherlands) provided at least three times a week
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 5 days (at least)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2-21.5 °C
- Humidity (%): 45-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours fluorescent light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.1 mL
Duration of treatment / exposure:
Not aplicable ( eye not rinsed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not applicable

SCORING SYSTEM: Scoring system same as recommended by OECD Guideline 405

CORNEAL IRRlTATlON
- Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal luster): 0
Scattered or diffuse areas of opacity, details of iris clearly visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacreous area, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4

- Area of cornea involved:
No ulceration or opacity: 0
One quarter or less but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4

IRIS
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneaI hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or all of these): 2

CONJUNCTIVAL IRRlTATlON
- Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson color, individual vessels not easily discernible: 2
Diffuse beefy red: 3

- Chemosis (refers to lids and/or nictitating membranes):
No swelling: 0
Any swelling above normal (includes nictitating membranes): 1
Obvious sweIling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4

- Discharge:
No discharge (may include small amounts observed in inner canthus of normal animals): 0
Any amount different from normal and/or lacrimation: 1
Discharge with moistening of the lids and hairs just adjacent to lids: 2
Discharge with moistening of the lids and hairs (considerable area around the eye): 3

TOOL USED TO ASSESS SCORE: Eye examinations were performed using fluorescein (2%) and/or an ophthalmic examination lamp (if standard lighting was inadequate)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
for each animal
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
- Irritation of the conjunctivae which consisted of redness, chemosis and discharge, completely resolved within 72 hours
- Remnants of the test substance were present and on the outside of the eyelids throughout the observation period
- See table 1 and 2 for further details
Other effects:
- No mortality or symptoms of systemic toxicity
- Slight bodyweight loss observed in one animal but considered of no toxicological relevance, based on the absence of corroborative findings

Any other information on results incl. tables

Table 1: Individual eye irritation scores

Animal

Time after dosing (hours)

Cornea

Iris

Conjunctivae

Comments

Opacity

Area

Fluor area (%)2

Redness

Chemosis

Discharge

8471

1

0

0

0

0

2

2

1

c

24

0

0

0

1

0

1

c

48

0

0

0

1

0

0

c

72

0

0

0

0

0

0

c

859

1

0

0

0

0

2

2

1

c

24

0

0

0

1

0

1

c

48

0

0

0

1

0

0

c

72

0

0

0

0

0

0

c

861

1

0

0

0

0

2

1

1

c

24

0

0

0

1

0

1

c

48

0

0

0

1

0

0

c

72

0

0

0

0

0

0

c

1Sentinel

2Green staining after fluorescein treatment (percentage of total corneal area)

c: Remnants of the test substance on the outside of the eyelids

Table 2: Mean (24, 48 and 72 hours) value eye irritation scores

Animal

 

 

Corneal opacity

 

 

Iris

 

 

Conjunctivae

Redness

Chemosis

847

0

0

0.7

0

859

0

0

0.7

0

861

0

0

0.7

0

Applicant's summary and conclusion

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

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted Bisphenol A epoxy diacrylatein one of the eyes while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 1, 24, 48 and 72 hours after dosing and graded according to the method of OECD Guideline 405.

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation completely resolved within 72 hours. 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; 0.7, 0.7, 0.7 for conjunctivae score and 0, 0, 0 for chemosis score.

Under the test conditions, Bisphenol A epoxy diacrylate is not classified as irritating to the eye according to the CLP Regulation (EC) N° (1272-2008).