Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 3 to 24 June 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Analytical purity: 96.5%
- Lot/batch No.: 5ABK-003

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Interfauna UK Ltd, Huntingdon, Cambridgeshire, England
- Age at study initiation: Approximately 13 weeks of age
- Weight at study initiation: 3.2 kg
- Housing: Housed individually in metal cages with perforated floors
- Diet (e.g. ad libitum): A standard laboratory diet SDS Stanrab (P) Rabbit Diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19℃
- Humidity (%): 30-70%
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hours period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 84 mg
- Concentration (if solution):

Duration of treatment / exposure:
Single instillation without washing
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1
Details on study design:
Due to the low pH of the test material (pH 1.98), one animal was treated in advance of others to ensure that if a severe response was produced, no further animals would be exposed. As a result of the severity of ocular reactions observed, no further animals were treated.
Approximately 84 mg of the test substance, the weight occupying a volume of 0.1 ml, it was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
The contralateral eye remained untreated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No reactions
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Blanching of nictating membrane
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Examination of the eye was made after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation.
The numerical values given to the ocular reactions elicited by this substance are shown below. No iridial inflammation was observed. Corneal opacification (Grade 4) was noted within one hour of dosing.
A diffuse beefy red colouration of the conjunctivae was seen, accompanied by blanching of the nictating membrane and swelling with partial eversion of the eyelids. These responses gradually ameliorated and the eye was normal 21 days after instillation.

Any other information on results incl. tables

There were no signs of toxicity or ill health in any rabbit during the observation period.

Rabbit number and sex

Region of eye

One hour

Day after instillation

1

2

3

4

7

14

21

2885 ♂

Cornea

Density

4

4

3

3

3

1

0

0

Area

1

1

1

1

1

1

0

0

Iris

0

0

0

0

0

0

0

0

Conjunctiva

Redness

2a

2a

3a

3a

3a

2

2

0

Chemosis

2

2

2

2

2

2

1

0

Pilot animal

A Blanching of nictating membrane

 

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Instillation of the substance into the rabbit eye elicited corneal opacification and moderate conjuntival irritation.