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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:
From February 16 to March 8, 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Source study has reliability 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
GLP compliance:
yes

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: Granja Cunicola San Bernardo S.L. (Tulebras, Navarra, Spain)
- Weight at study initiation: 2.6 - 3.1 kg
- Housing: individually in stainless steel cages(52 × 58 × 43 cm) with a grille floor and placed on a rack
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 -23 °C
- Humidity: 30 - 60 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 1 h

SCORING SYSTEM:
Cornea opacity:
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous area, no details of iris visible, size of pupil barely perceptible
4 opaque cornea, iris not discernible through the opacity

Iris:
0 normal
1 markedly deepend rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection (any of these or a combination thereof), iris still reacting to light (a sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae redness:
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson clour, individual vessels not easily discernible
3 diffuse beefy red

Conjunctivae edema:
0 no swelling
1 slight swelling (includes nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
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 and #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:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

animal region of eye 1 h 24 h 48 h 72 h 7 d
1 cornea opacity 0 0 0 0 0
iris 0 0 0 0 0
conjunctivae redness 2 1 1 0 0
conjunctivae edema 2 1 0 0 0
2 cornea opacity 0 1 1 0 0
iris 0 0 0 0 0
conjunctivae redness 2 2 1 1 0
conjunctivae edema 2 1 0 0 0
3 cornea opacity 0 0 0 0 0
iris 0 0 0 0 0
conjunctivae redness 2 2 1 1 0
conjunctivae edema 1 1 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit eye.
Executive summary:

Method

OECD guideline 405. 0.1 g of test substance was instilled in one eye of 3 rabbits; the other eye served as control. 1 hour after start of exposure, removal of residues with physiological saline was done. Observations were carried out 1, 24, 48, 72 hours after start up to 7 day; effects in terms of corneal opacitiy, iris, conjunctivae redness and chemosis were evaluated.

Results

Slight effects on corneal opacity were seen in 1/3 rabbit; effects on conjunctivae in terms of redness and chemosis were seen in 3/3 rabbits. All such effects were fully reversible within 7 days.