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Diss Factsheets

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 1996-04-19 to 1996-07-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 405, (1987)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Peroxidase
EC Number:
232-668-6
EC Name:
Peroxidase
Cas Number:
9003-99-0
Molecular formula:
Not applicable, see remarks.
IUPAC Name:
Peroxidase IUBMB 1.11.1.7
Constituent 2
Reference substance name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available
IUPAC Name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 3
Reference substance name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available.
IUPAC Name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 4
Reference substance name:
Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available.
IUPAC Name:
Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
Constituent 5
Reference substance name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available.
IUPAC Name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Test material form:
solid: particulate/powder
Details on test material:
- Lot/batch No.: PPX 5156
- Expiration date of the lot/batch: At least 2005.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred by Novo Nordisk A/S
- Age at study initiation: 19 weeks
- Weight at study initiation: 2.6-2.7 kg
- Housing: Individually in plastic cages with mesh floor
- Diet: 130 g standard diet per day
- Water: Tap water ad libitum
- Acclimation period: 6-7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

IN-LIFE DATES: From: 1996-04-29 To: 1996-05-03

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Test batch used as is:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g enzyme concentrate dry matter into the left eye
Duration of treatment / exposure:
The test material was applied to the conjunctival sac.
Observation period (in vivo):
The reactions were judged 1, 24, 48 and 72 hours after instillation of the test material.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the guideline.

Grading of Ocular Lesions:
CORNEA
Opacity : Degree of density (area most dense taken for reading)
No ulceration or opacity ...................................................................................................... 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster,
details of iris clearly visible) ................................................................................................ 1
Easily discernible translucent areas, details of iris slightly obscured ..................................2
Nacreous areas, no details of iris visible, size of pupil barely discernible ...........................3
Opaque cornea, iris not discernible through the opacity ......................................................4
IRIS
Normal ...................................................................................................................................0
Markedly deepened rugae, congestion, swelling, moderate circum corneal hyperaemia,
or injection, any of these or any 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
CONJUNCTIVAE
Redness : (Refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal .............................................................................................................0
Some blood vessels definitely hyperemic (injected) ..............................................................1
Diffuse, crimson colour, individual vessels not easily discernible .........................................2
Diffuse beefy red ...................................................................................................................3
Chemosis : Lids and/or nictating membranes
No swelling .............................................................................................................................0
Any swelling above normal (includes nictating membranes) .................................................1
Obvious swelling with partial eversion of lids ........................................................................2
Swelling with lids about half closed .......................................................................................3
Swelling with lids more than half closed ................................................................................4
Flourescein 2% w/w was used, if there were signs of corneal opacity/ulcerations.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.6
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corneal reactions, no iris reactions were observed in any of the animals at the 1-, 24-, 48- and 72-hour reading.
Animal no. 4 showed conjunctival redness at the readings 1, 24 and 48 hours after test substance application. Rabbits no. 4 and 7 showed similar reactions at 1 and 24 hours after application. The scores were 1 in all situations. However, this was fully reversible after 72 hours.
The rabbits showed no sign of systemic reaction to the treatment. The weight of the animals was not influenced by the treatment
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The instillation of 0.1 g enzyme concentrate dry matter to the conjunctival sac of 3 rabbits caused no signs of eye irritation, and under the test conditions peroxidase is not to be classified and can be considered as 'non irritant'.
Executive summary:

In accordance with the OECD guideline 405, a test for eye irritation in rabbits was performed with Peroxidase, batch PPX 5156. The eyes of three animals were checked for defects or irritation before instillation and only animals without defects were used. 


 


0.1 g enzyme concentrate dry matter was placed in the conjunctival sac of the left eye by pulling the lower eyelid away from the eyeball. The lids were gently held together for about one second after instillation. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the specified guideline.


 


No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Conjunctival redness was observed after 24 hours in all three rabbits, and after 48 hours in 1 rabbit (maximum score of 1). All signs were fully reversible, and no reactions were seen after 72 hours.


 


In conclusion, peroxidase can be classified as a 'non-irritant' to the rabbit eye.