Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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 August 8 to 22, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Complete read-across justification is attached in section 13. Source study has reliability 1.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes (incl. certificate)

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: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 15 weeks (males), 14 weeks (females)
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 to 7 days under laboratoy conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23.5 °C
- Humidity: 44 - 79 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h light and 12 h dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g.
Duration of treatment / exposure:
Eye non rinsed after instillation.
Observation period (in vivo):
Up to 7 days after application.
Number of animals or in vitro replicates:
2 females and 1 male.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal luster), 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 discernible
4 Opaque cornea, iris not discernible through the opacity

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

CONJUNCTIVAE
Redness (refers to most severe reading of palpebral and bulbar conjunctivae when compared with control eye)
0 Blood vessels normal
1 Some blood vessels definitely hyperemic (injected)
2 Diffuse, crimson color, individual vessels not easily discernible
3 Diffuse beefy red
Chemosis: lids and/or nictitating membranes
0 No swelling
1 Any swelling above normal (including 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: Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
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:
conjunctivae score
Basis:
animal: #1 and #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 #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
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
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Other effects:
- Mortality and clinical signs: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Irritation: no corneal and iridal effects were observed. Slight to moderate redness of the conjunctivae and/or nictitating membrane was recorded for all animals from 1 to 48 hours after treatment. The redness diminished and cleared in two animals at 72 hours and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. Moderate reddening of the sclera was observed in all animals at the 1-hour examination. The scleral redness diminished to slight at 24 hours and cleared in one animal by 48 hours and in two animals by 72 hours. A slight watery discharge was noted in one animal at the 1-hour reading. All eye reactions were clear within 7 days after treatment.
- Coloration: no staining of the treated eyes by the test item was observed. Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.
- Corrosion: no corrosion of the cornea was observed at any of the reading times.
- Body weights: body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

Eye irritation scores - individual values

animal evaluation time corneal opacity iris conjunctivae
redness chemosis
M 1 h 0 0 1 0
F 0 0 2 2
F 0 0 2 2
M 24 h 0 0 1 0
F 0 0 1 1
F 0 0 2 1
M 48 h 0 0 1 0
F 0 0 1 0
F 0 0 1 0
M 72 h 0 0 0 0
F 0 0 0 0
F 0 0 1 0
M 7 d 0 0 0 0
F 0 0 0 0
F 0 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 the rabbit eye.
Executive summary:

Method

Eye irritation study carried out according to OECD guideline 405. Instillation of 0.1 g of test substance into one eye of 3 rabbits (2 F and 1 M). The eye was not rinsed and and scoring for effects was done 1, 24, 48, 72 h and 7 d after application.

Results

No signs of corneal opacity and iris lesions were noted. Slight to moderate redness of the conjunctivae and/or nictitating membrane was noted for all animals up to 48 h after treatment. The redness diminished and cleared in two animals at 72 h and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. A slight watery discharge was noted in one animal at the 1-hour reading.

No staining of the treated eyes by the test item was observed. Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.

No corrosion was observed at any of the measuring intervals.

All eye reactions were clear within 7 days after treatment.