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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:
11-02-1994 to 22-03-1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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:
TEST ANIMALS
- Source: Not reported.
- Age at study initiation: Young adult.
- Weight at study initiation: 2122 - 2285 g
- Housing: Individual suspended mesh-bottom cages.
- Diet: Purina® Certified Rodent Chow® #5322 provided ad libitum
- Water: Municipal water were provided ad libitum
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of six days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature : 66-72°F
- Humidity (%): 34-80
- Photoperiod (hrs dark / hrs light): 12/ 12.

IN-LIFE DATES: From: 18-04-1994 To: 24-05-1994.

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:
Group 1- Single exposure, without washing.
Group 2 - Single exposure, with washing after 30 seconds.
Observation period (in vivo):
1, 24, 48 and 72 hours after dosing and on days 4, 7, 14, 21 and 28.
Number of animals or in vitro replicates:
4 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The rabbits in group 2 were given a washout 30 sec after instillation with 100 ml of sterile saline over a period of 20 seconds. The eyes of the animals in group 1 remained unwashed.
- Time after start of exposure: Approximately 30 seconds following administration of the dose.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Remarks on result:
other: Corneal opacity persisted through Day 28 (study termination).
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 28 days
Remarks on result:
other: Minor conjuctival redness persisted through Day 28 (study termination).
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
4
Max. score:
2
Reversibility:
fully reversible within: 28 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The test material induced generally moderate ocular irritation including positive corneal and conjunctival irritation in the right eye of all animals and positive iridal reactions for three and two, unwashed and washed rabbits, respectively. Iridal irritation completely subsided by day 14 or earlier for the unwashed group and by day 4 for the washed group. Corneal irritation completely subsided by day 21 or earlier for all washed animals and by day 14 or earlier for two of the unwashed animals. Minor, reversible conjunctival redness persisted through day 21 for one washed eye. Corneal opacity and minor conjunctival redness persisted through day 28 (study termination) for one unwashed animal.

Any other information on results incl. tables

 Table 1. Ocular Irritation

Group

No. with ocular reactions/ No. treated

Cornea

Iris

Conjunctiva

Total

0.1 ml/ right eye, unwashed

3/3

3/3

3/3

3/3

0.1 ml/ right eye, washed

3/3

2/3

3/3

3/3

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A reliable eye irritation study, conducted according to OECD 405 and GLP, showed the test material to be a Category 1 eye irritant (EU).