Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is not performed under GLP but there was inhouse QA. The study was performed similar to OECD 405 reporting was not done in full detai.CoA is not included.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
but inhouse quality assurance authentication was performed

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
test substance: EN 422
Batch Number: BX PPL 2
The test material was in the form of a viscous brown liquid and was stored i n the dark under ambient conditions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited
- Age at study initiation: no data
- Weight at study initiation: 2.5-3.0 kg
- Housing: housed individually in cages with a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): Ad libitum: Special Diet Services (S.D.S.) Rabbit Diet of satisfactory analysis
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 ± 2
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: each animal served as its own control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24h after which the animals were sacrificed for humane reasons
Observation period (in vivo):
observations were done at 1 and 24h
Number of animals or in vitro replicates:
two males and one female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : eye not rinsed

SCORING SYSTEM:OECD: Acute Eye Irritation/Corrosion Test i n Rabbits Grades for Ocular Lesions
Cornea
No ulceration or opacity ........................................... 0
Scattered or diffuse areas of opacity ,
details of iris clearly visible .................... .... ........... I*
Easily discernible translucent areas of
opacity, details of iris slightly obscured ........................ 2*
Nacreous areas of opacity, no details of iris
visible, size of pupil barely discernible ......................... 3*
Complete corneal opacity, iris not discernible ...................... 4*
Ulceration, absence of a gross
patch of corneal epithelium ....................................... 4*

Iris
Normal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Markedly deepened folds, congestion, swelling,
moderate circumcorneal injection (any of these or
combination of any thereof), iris still reacting
to light (sluggish reaction i s positive) .......................... l*
No reaction to light, haemorrhage, gross
destruction (any or all of these) ................................. 2*

Conjunctivae
Redness (refers to pal pebral and bul bar
conjunctivae excluding cornea and iris) :
Vessels normal ...................................................... 0
Some vessels definitely injected ..................................... 1
Diffuse crimson red, individual vessels
not easily discernible ........................................... 2*
Diffuse beefy red . . . . . . . . . . . . . . . . . . . . .... . . . . . . . . . . . . . . . . . . . . . . . . . . . 3*

Chemosis
No swelling ........................................................ 0
Any swelling above normal (including nictitating membrane) ........... 1
Obvious swelling with partial eversion of lids ....................... 2*
Swelling with lids about half closed ........ . ....... . ............. ... 3*
Swelling with lids more than half closed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4*
Ulceration or necrosis of palpebral and bulbar
conjunctivae ornictitating membrane ............................... 4*

Discharge
Mild ................... ... ........ ................ ...............1
Moderate ........................................................2
Severe ............................................................ 3

* F i gures indicate the grades considered positive.

TOOL USED TO ASSESS SCORE: standard illumination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
other: For humane reasons the animal was killed after 24h
Remarks on result:
other: Additionally: severe discharge
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
other: For humane reasons the animal was killed after 24h
Remarks on result:
other: Additionally: severe discharge
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
other: For humane reasons the animal was killed after 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
other: For humane reasons the animal was killed after 24h
Remarks on result:
other: Additionally: severe discharge
Irritant / corrosive response data:
Cornea and Iris
It was not possible to assess corneal reactions at 1h in any animal because o f intense conjunctival swelling. At 24 h positive corneal reactions (score1 and 2) were noted in all animals. Positive iridial responses (score 1) were noted in all eyes at 1 and 24 h.

Conjunctival
Moderate conjunctival redness (score 2) and severe chemosis (score 3-4) were noted in all eyes at 1 and 24 h. Severe discharge (score 3) was noted
in all eyes at 1 and 24h.
Other effects:
All animals were sacrificed after the 24h reading on humane grounds.

Any other information on results incl. tables

Eye irritation/corrosion test in rabbits.

Rabbit No/Sex

1 hour

24 hours

1

2

3

1

2

3

Cornea

+

+

+

1

2

2

Iris

1

1

1

1

1

1

Conjunctivae:

 

 

 

 

 

 

   redness

2

1

2

2

2

2

   chemosis

4

3

4

4

4

4

   discharge

3

3

3

3

3

3

Total

10

8

10

11

12

12

+ = unable to read due to intense swelling

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance elicited positive corneal, iridial and conjunctival responses in all eyes at 1 and 24h. Because of the severe nature of the responses and following a veterinary inspection the rabbits were humanely sacrificed following the 24h reading.
Executive summary:

The potential of the test substance to induce eye irritation was assessed in 3 rabbits according to a method similar to OECD guideline 405.

A statement that the report was audited by the Quality Assurance Unit of the testing laboratory was provided.

A single dose of 0.1ml of the testsubstance was instilled into one eye, the other eye was not treated and served as control.The eyes were not rinsed after administration of the test item. Ocular reactions were observed 1 hour and 24 hours later.

It was not possible to assess corneal reactions at 1 hour in any animal because of intense conjunctival swelling. At 24 hours corneal scores of 1 or 2 were noted in all animals. Positive iridial scores of 1 were noted in all animals at 1 and 24 hours. Moderate conjunctival redness (score 2) and severe chemosis (score 4) were noted in all rabbits at 1 and 24 hours. Severe discharge was also noted in all rabbits.

Due to the severe nature of the reactions observed, the rabbits were sacrificed after the 24 hour recording on humane grounds. The authors concluded that the test substance was severely irritating to the eye.