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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:
Oct. 1, 1990 - Oct. 4, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Oct. 1, 1990 - Oct. 4, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week

IN-LIFE DATES: From: Oct. 1, 1990 To: Oct. 4, 1990
Vehicle:
unchanged (no vehicle)
Controls:
other: the non-treated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water 30 seconds after start of exposure. The eyes of the remaining 6 animals were unwashed.
Observation period (in vivo):
72 hrs at which time no animals showed signs of irritation.
Number of animals or in vitro replicates:
9 animals total
3 males and 3 females were used in the unwashed eye experiment
3 males were used in the washed eye experiment
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water. The eyes of the remaining 6 animals were unwashed.
- Time after start of exposure: 30 seconds after start of exposure


SCORING SYSTEM: According to EPA guidelines 81-4


TOOL USED TO ASSESS SCORE: All animals were examined with 0.2% fluorescein sodium ophthalmic solution at the 24 hr observation . Since no fluorescein staining was seen in any animal, the examination was not repeated at later observations.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: unwashed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritant / corrosive response data:
All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.
Other effects:
No other effects were observed in any animal at any observation.

Individual Eye Irritation Scores - Washed

Animal

1 hr

24 hrs

48 hrs

72 hrs

9960-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9962-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9964-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

Individual Eye Irritation Scores - Unwashed

Animal

1 hr

24 hrs

48 hrs

72 hrs

9954-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9956-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9958-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9957-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9959-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9961-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively.  The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0.  The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation.  Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

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: Ray Nichols Rabbitry, Lumberton, TX
- Age at study initiation: 3-6 months
- Weight at study initiation: N/A
- Housing: Singly in wire-bottomed, suspended, stainless steel cages, identified by ear tags
- Diet (e.g. ad libitum): Purina Rabbit Chow in measured amounts
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: one week

IN-LIFE DATES: From: Oct. 1, 1990 To: Oct. 4, 1990

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the non-treated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water 30 seconds after start of exposure. The eyes of the remaining 6 animals were unwashed.
Observation period (in vivo):
72 hrs at which time no animals showed signs of irritation.
Number of animals or in vitro replicates:
9 animals total
3 males and 3 females were used in the unwashed eye experiment
3 males were used in the washed eye experiment
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes of 3 of the nine animals were washed for one minute with room temperature deionized water. The eyes of the remaining 6 animals were unwashed.
- Time after start of exposure: 30 seconds after start of exposure


SCORING SYSTEM: According to EPA guidelines 81-4


TOOL USED TO ASSESS SCORE: All animals were examined with 0.2% fluorescein sodium ophthalmic solution at the 24 hr observation . Since no fluorescein staining was seen in any animal, the examination was not repeated at later observations.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: unwashed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0
Remarks on result:
other: unwashed eyes
Irritant / corrosive response data:
All six of the unwashed animals showed redness (score of 1) at the 1 and 24 hr observations. The three females and one male also showed chemosis (score of 1) at the 1 hr observation. All symptoms were resolved at the 48 hr observation. All three washed animals showed redness (score of 1) at the 1 and 24 hr observation. These symptoms were also resolved by the 48 hr observation.
Other effects:
No other effects were observed in any animal at any observation.

Any other information on results incl. tables

Individual Eye Irritation Scores - Washed

Animal

1 hr

24 hrs

48 hrs

72 hrs

9960-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9962-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9964-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

Individual Eye Irritation Scores - Unwashed

Animal

1 hr

24 hrs

48 hrs

72 hrs

9954-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9956-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9958-M

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

0

0

0

0

Conjunctiva, discharge

0

0

0

0

9957-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9959-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

9961-F

Cornea, opacity

0

0

0

0

Cornea, area

0

0

0

0

Iris

0

0

0

0

Conjunctiva, redness

1

1

0

0

Conjunctiva, chemosis

1

0

0

0

Conjunctiva, discharge

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively. The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0. The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.33, 0.33, and 0.33 respectively.  The mean erythema score was 0.33. The scores for chemosis were 0, 0, and 0.  The mean erythema score was 0.0. There were no positive scores for corneal, or iridial irritation.  Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.