Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed GLP and OECD guideline study

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
84/449/EEC
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG breeding colony
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 2.6 kg to 3.6 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Albtromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 3°C (air-condition)
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 hours
rinsing with physiolog. saline 24 h post instillation
Observation period (in vivo):
72 h post instillation
Number of animals or in vitro replicates:
3
Details on study design:
Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 48, 53 75 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: # 48, 53, 75 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0.4
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: # 48, 53,75 each
Time point:
other: mean of 24, 48 and 72 h
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: # 48, 53, 75 each
Time point:
other: mean of 24, 48 and 72 h
Score:
2.4
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The conjuntciva of all animals were diffuse reddened and swollen with lids about half closed 1 h until 72 h after application. 24 h until 48 h after treatment the iris was reddened. Scattered and diffuse corneal opacity was observed at 24 until 72 h. All signs of irritation were fully reversible after 7 days.
Other effects:
Clear, colourless eye discharge was observed at 1 hour and 24 h after application. White-mucous discharge after 48 h.

Any other information on results incl. tables

Table 1: individual scores:

Animal no

Evaluation Interval

Cornea

Conjunctiva

Iris

 

 

Opacity

Redness

Chemosis

Discharge

 

48

1 h

0

2

2

X

0

53

0

2

1

X

0

75

0

2

2

X

1

48

24 h

0

3

3

X

1

53

0

3

2

X

1

75

1

2

2

X

1

48

48 h

0

3

1

 

0

53

0

3

1

 

0

75

1

3

2

X

1

48

72 h

0

2

1

 

0

53

0

1

0

 

0

75

1

2

1

 

0

48

7 d

0

0

0

 

0

53

0

0

0

 

0

75

0

0

0

 

0

Applicant's summary and conclusion

Interpretation of results:
other: Irritating to eyes, category 2
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Regulation (EC) No 1272/2008: Irritating to eyes, category 2, H319
Directive 67/548/EEC: no classification

In a OECD guideline and GLP compliant primary eye irritation test in rabbits, the test item caused grade 2 (mean of 24, 48 and 72 h, three animals) conjunctival redness. Thus, the test item has to be classified as "Irritating to eyes, category 2" according to (EC) No 1272/2008

The mean scores (of all animals as well for individuals) for all irritation parameter did not meet the classification criteria for "Irritating to eyes according to Directive 67/548/EEC.
Executive summary:

A study with the test item according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

The conjuntcivae of all animals were diffuse reddened and swollen with lids about half closed 1 h until 48 h after application. 24 h until 48 h after treatment the iris was reddened. Scattered and diffuse corneal opacity was observed at 24 and 72 h. All signs of irritation were reversible after 7 days.

The test item caused grade 2.4 (mean of 24, 48 and 72 h, three animals) conjunctival redness. Thus, the test item has to be classified as "Irritating to eyes, category 2" according to (EC) No 1272/2008

The mean scores (of all animals as well as for individuals) for all irritation parameter did not meet the classification criteria for "Irritating to eyes according to Directive 67/548/EEC.