Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 December 2000 to 22 December 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
- Physical state: brown semi-solid
- Storage condition of test material: room temperature and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA, USA
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: individually in suspended cages. Bedding was placed underneath cages and changed three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least 5 days
- Health: all animals were found to be free from evidence of ocular irritation or abnormalities before being assigned to the study

ENVIRONMENTAL CONDITIONS
- Animals were placed in a temperature controlled room which had a 12 hour light/dark cycle

IN-LIFE DATES: From: 29 November 2000 To: 22 December 2000

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
Duration of treatment / exposure:
- Dose administration: Approximately 0.1 mL of the test material was placed by syringe into the conjunctival sac which was formed by gently pulling the lower eyelid away from the eye. After instillation, the lids were held together for approximately one second to insure adequate distribution of the test material. One eye of each rabbit was dosed. The contralateral eye served as a control.
Observation period (in vivo):
Animals were observed for 72 hours post administration.
Number of animals or in vitro replicates:
One animal initially, followed by a further two animals once the irritation potential was fully assessed in the first animal.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Not reported

SCORING SYSTEM
- The reactions observed were scored 1, 24, 48 and 72 hours post administration, in accordance with the criteria of Draize. The scale for scoring ocular reactions is presented as Table 1 in the field "Any other information on materials and methods incl. tables".
- Bodyweights were recorded pre-test
- The general health of the animals was monitored at each observation time

TOOL USED TO ASSESS SCORE
- Sodium fluorescein dye was used at the 24 hour observation interval. These examinations were performed using a Mini-Maglite flashlight equipped with a high intensity bulb.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable - no reactions seen
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable - no reactions seen
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation noted in all 3 eyes, cleared by 72 hours.
Other effects:
There were no abnormal physical signs noted during the observation period.

Any other information on results incl. tables

Table 2: Results

Animal

Tissue

Reading

1 hour

24 hours

48 hours

72 hours

1 M

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

1. Total

0

0

0

0

Iris

0

0

0

0

2. Total

0

0

0

0

Conjunctiva

Redness

2

2

2

0

Chemosis

1

1

0

0

Discharge

2

1

0

0

3. Total

10

8

4

0

Total = 1 + 2 + 3

10

8

4

0

Systemic observations

A

A

A

A

Sodium fluorescein

0

Pre-test bodyweight

2.4 kg

2 M

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

1. Total

0

0

0

0

Iris

0

0

0

0

2. Total

0

0

0

0

Conjunctiva

Redness

1

1

1

0

Chemosis

1

0

0

0

Discharge

1

0

0

0

3. Total

6

2

2

0

Total = 1 + 2 + 3

6

2

2

0

Systemic observations

A

A

A

A

Sodium fluorescein

0

Pre-test bodyweight

2.7 kg

3 M

Cornea

Opacity

0

0

0

0

Area

0

0

0

0

1. Total

0

0

0

0

Iris

0

0

0

0

2. Total

0

0

0

0

Conjunctiva

Redness

2

2

1

0

Chemosis

1

1

1

0

Discharge

2

1

0

0

3. Total

10

8

4

0

Total = 1 + 2 + 3

10

8

4

0

Systemic observations

A

A

A

A

Sodium fluorescein

0

Pre-test bodyweight

2.5 kg

 

A = Normal

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Under the conditions of the study, the test material only elicited slight reactions in the animals during the course of the study that meant the test material does not require classification as an eye irritant in accordance with EU criteria. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The eye irritation potential of the test material was determined in accordance with the standardised guideline EPA OPPTS 870.2400. During the study, 0.1 mL of test material was applied into one eye of three New Zealand White rabbits; the animals were assessed for 72 hours to determine the grade of ocular reaction.

There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, which was noted in all three treated eyes, had fully cleared by 72 hours.

Under the conditions of the study, the test material only elicited slight reactions in any of the animals during the course of the study that meant the test material does not require classification as an eye irritant in accordance with EU criteria.