Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
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:
1988
Report Date:
1988

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: 2.0 kg to 2.5 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 physiol. 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: # 1, 2, 3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
chemosis score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: grade 2 chemosis was observed in all animals at 1 hour and was fully reversible within 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The score refers to redness of conjunctiva, which was evident in all animals 1 h after treatment (score 2 in all 3 animals). The value of 0.33 is the mean (of the three assessments at 24, 48 and 72 h) for all animals combined as well as for each individual animal. At 48 and 72 h, this score was 0 in all animals. Other parameters examined (opacity of cornea, iris) showed scores of 0 at any time.
Other effects:
Clear, colourless eye discharge was observed at 1 hour after application.

Any other information on results incl. tables

Table 1: individual scores:

Animal no

Evaluation Interval

Cornea

Conjunctiva

Iris

 

 

Opacity

Redness

Chemosis

Discharge

 

1

1 h

0

2

2

X

0

2

0

2

2

X

0

3

0

2

2

X

0

1

24 h

0

1

0

0

0

2

0

1

0

0

0

3

0

1

0

0

0

1

48 h

0

0

0

0

0

2

0

0

0

0

0

3

0

0

0

0

0

1

72 h

0

0

0

0

0

2

0

0

0

0

0

3

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Not irritating to eyes

In a OECD guideline and GLP compliant primary eye irritation test in rabbits, the test item caused grade 2 chemosis and grade 2 conjunctival reddening after 1 h. No effects were observed for these and other parameters at the other reading times 48 to 72 hours. Therefore, the test item can be regarded as notirritating to eyes.
Executive summary:

The primary eye irritation potential of the test item was investigated according to OECD Guideline no. 405. the test item was applied by instillation into the conjunctival sac of the left eyes of 3 young adult New Zealand White rabbits, the right eyes served as control respectively. The mean scores were calculated across 3 scoring times (24, 48 and 72 h after application) for iris, cornea, conjunctiva redness and conjunctiva chemosis separately.

Reddened and swollen conjunctivae were evident in all animals 1 h after treatment. At 48 and 72 h, this score was 0 in all animals. Other parameters examined (cornea, iris) showed scores of 0 at any time. 48 hours after treatment all signs of irritation were reversible.

Based upon these findings, the test item is considered ti be "not irritating" to the rabbit eye.