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
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Six rabbits were tested in total and three of the test eyes were washed following administration
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
reliability scoring based on 2002 guideline
Deviations:
yes
Remarks:
Six rabbits were tested in total and three of the test eyes were washed following administration
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum, Ssniff Mu Z (pellets), Ssniff Spezialdiaten GmbH
- Water (e.g. ad libitum): ad libitum, drinking water
- Acclimation period: At least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2°C
- Humidity (%): 50 to 85%
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:
0.1 mL of the test material was placed into the conjunctival sac of the left eye while the right eye served as control. On animal #4 to 6 the treated eye was washed out 4 seconds post-administration with 10 mL lukewarm water.
Observation period (in vivo):
1, 24, 48, and 72 hour
Number of animals or in vitro replicates:
6 animals in total
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was done in animals #4 to 6
- Time after start of exposure: 4 seconds after administration


SCORING SYSTEM:
Cornea opacity- degree of density (area most dense taken for reading): Grade

No ulceration or opacity: 0
Scattered or diffused areas of opacity (other than slight dulling of normal lustre); 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: Grade

Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, cornea, and iris): Grade

Blood vessels normal: 0
Some blood vessel definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red appearance: 3

Chemosis (lids and/or nictating membranes): Grade

No swelling: 0
Any 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


TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1, 24, 48, 72 hours after treatment. The eyes were also examined for potential eye lesions at 24 and 72 hours post-administration by means of 1% fluorescein-dilution (1 drop/eye). It was washed out about 60 seconds post administration with sterile, non-pyrogenic, physiological saline.

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, 72
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, 72
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, 72
Score:
1.25
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, 72
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, 72
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, 72
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 24 hours

Any other information on results incl. tables

It should be noted that for the purposes of this dossier in accordance with OECD guidelines, results from individual animals in which the eyes were washed are not reported.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified