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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
study conducted on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.
Justification for type of information:
The read across justification is detailed in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
other: REAL DECRETO 363/1995, 10 march
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: authorised supplier
- Weight at study initiation: 2099-2191 g
- Housing: stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorised vendor
- Water: filtered tap water (5 µm), ad libitum
- Acclimation period: 7 days
- Health check: during observation period

ENVIRONMENTAL CONDITIONS
- Temperature: 21± 2 °C
- Humidity:55 ± 25 %
- Air changes: 15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod: 12 hour cycle dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 males
Details on study design:
OBSERVATIONS: after 1, 24, 48, 72 hours and 7,14, and 21 days

SCORING SYSTEM: cornea, iris, conjunctiva (similar to OECD 405)
Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity .............................................................................................................. 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible ................................................................................................................... 1
Easily discernible translucent area; details of iris slightly obscured ........................................... 2
Nacrous area; no details of iris visible; size of pupil barely discernible ..................................... 3
Opaque cornea; iris not discernible through the opacity ............................................................. 4
Maximum possible: 4
* The area of corneal opacity should be noted Iris

Iris
Normal......................................................................................................................................... 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect.................... 1
Hemorrhage, gross destruction, or no reaction to light ............................................................... 2
Maximum possible: 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) Normal......................................................................................................................................... 0
Some blood vessels hyperaemic (injected) ................................................................................. 1
Diffuse,crimson colour; individual vessels not easily discernible............................................... 2
Diffuse beefy red ......................................................................................................................... 3
Maximum possible: 3

Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal......................................................................................................................................... 0
Some swelling above normal....................................................................................................... 1
Obvious swelling, with partial eversion of lids........................................................................... 2
Swelling, with lids about half closed........................................................................................... 3
Swelling, with lids more than half closed.................................................................................... 4
Maximum possible: 4


TOOL USED TO ASSESS SCORE: fluorescein

To facilitate consideration of the reactions, the operator used a manual lamp. After 24 hours of application, fluorescein was usedto evaluate any lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Table 1: eye irritation scores

  1hour 24 hours 48 hours 72 hours 7 days 14 days 21 days
animal #1              
corneal opacity - 1 1 1 0 0  
iritis - 1 1 1 0 0  
conjunctival redness - 3 2 2 1 0  
conjunctival oedema (chemosis) 3 3 2 2 0 0  
 
animal #2              
corneal opacity - 1 1 1 0 0  
iritis - 1 1 1 0 0  
conjunctival redness - 3 2 2 1 0  
conjunctival oedema (chemosis) 3 4 3 3 0 0  
 
animal #3              
corneal opacity - 1 1 1 0 0  
iritis - 1 1 1 0 0  
conjunctival redness - 3 3 2 1 0  
conjunctival oedema (chemosis) 3 4 3 2 0 0  

Applicant's summary and conclusion

Interpretation of results:
other: Category 2 (eye irritant) according to the CLP Regulation (EC) No. 1272/08
Conclusions:
The test item was found to be irritating when applied to the rabbit eye.
Executive summary:

The potential for the test item to induce eye irritation or serious damage was evaluated in an experimental study, according to a method similar to the OECD Guideline 405. Three male rabbits were administered 100 mg of unchanged test item to one eye for a duration of 24 hours; the untreated eye served as a negative control. Corneal opacity, iritis, conjunctival redness and chemosis were evaluated 1, 24, 48 and 72 hours and 7, 14 and 21 days after application of the test item.

The cornea and iris scores (mean values 24/48/72) were 1 in all animals. The mean values 24/48/72 h for conjunctivae for redness were 2.33 in two animals (#1 and #2) and 2.67 in one animal (#3); for chemosis were 2.33 in animal #1, 3.33 in animal #2 and 3 in animal #3. All effects observed were fully reversible within the 21-day observation period.