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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:
10 November 1980 to 17 November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
no
Remarks:
Study predates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): C-193; SN 2188-3; Aldehyde C9 Nonylic
- Appearance: Colourless liquid
- Storage condition of test material: Room temperature (stored under nitrogen)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: 2.2 to 2.9 kg
- Housing: Animals were housed individually in suspended stainless steel cages
- Diet: Purine rabbit chow, available ad libitum
- Water: Automatic watering system (municipal water supply) available ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 20.5 °C; monitored twice daily
- Humidity: monitored daily
- Photoperiod: 12 hours light, 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye served as the control.
Amount / concentration applied:
0.1 mL of the test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to prevent loss of material.
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Up to 7 days
Number of animals or in vitro replicates:
9 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
The treated and control eyes of 6 animals remained unwashed. Twenty seconds after the test substance was administered, both eyes of the remaining 3 animals were rinsed for one minute with lukewarm water.

OBSERVATIONS
-Viability checks were performed twice daily.
- Evaluations of eye irritation were performed approximately 24, 48 and 72 hours and 4 and 7 days after treatment. If there were no signs of irritation on Day 7, no additional observations were made.
- At each interval the treated and control eyes were examined and scored for ocular reactions. Unusual effects were also noted when present.

SCORING SYSTEM: Draize scale (see Appendix A in section "Attached background material")

TOOL USED TO ASSESS SCORE: Fluorescein dye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: All animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: All scores were 0
Irritation parameter:
iris score
Basis:
animal: All animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: All scores were 0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score for redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1.67
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean score for redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean score for redness
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean score for redness
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score for redness
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1.67
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Mean score for redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Mean score
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: Mean of 24, 48 and 72 h scores
Score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Mean score
Irritant / corrosive response data:
All nine rabbits exhibited positive scores for conjunctival redness and five animals with unwashed eyes showed positive scores for conjunctival chemosis. Conjunctival necrosis was observed in three animals with unwashed eyes. A positive score for iridial irritation was observed in one rabbit with washed eyes. All animals were free of signs of ocular irritation within seven days after administration of the test material.

The individual scores are given in Table 1.

The results from the animals whose eyes were washed have not been included as part of the classification assessment.

Any other information on results incl. tables

Table 1: Individual ocular scores

-

Time after administration

24 hours

48 hours

72 hours

4 days

7 days

Animal No. 6408F

Conjunctivae:

-

-

-

-

-

Redness

2

2

0

1

0

Chemosis

2

1

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

0

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6409M

Conjunctivae:

-

-

-

-

-

Redness

2

2

1

0

0

Chemosis

2

1

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

N

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6410F

Conjunctivae:

-

-

-

-

-

Redness

3

2

1

0

0

Chemosis

2

1

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

0

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6411M

Conjunctivae:

-

-

-

-

-

Redness

2

2

2

0

0

Chemosis

2

1

0

0

0

Discharge

1

0

0

0

0

Necrosis (N)

N

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6412F

Conjunctivae:

-

-

-

-

-

Redness

2

1

0

0

0

Chemosis

1

0

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

0

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6415M

Conjunctivae:

-

-

-

-

-

Redness

2

2

1

0

0

Chemosis

2

1

0

0

0

Discharge

2

0

0

0

0

Necrosis (N)

N

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6414Fb

Conjunctivae:

-

-

-

-

-

Redness

2

0

0

0

0

Chemosis

0

0

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

0

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6417Mb

Conjunctivae:

-

-

-

-

-

Redness

2

1

0

0

0

Chemosis

1

0

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

0

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

0

0

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

Animal No. 6418Fb

Conjunctivae:

-

-

-

-

-

Redness

2

1

1

0

0

Chemosis

0

0

0

0

0

Discharge

0

0

0

0

0

Necrosis (N)

0

0

0

0

0

Ulceration (U)

0

0

0

0

0

Iris

1

1

0

0

0

Cornea

-

-

-

-

-

Opacity

0

0

0

0

0

Area

0

0

0

0

0

Stippling

0

0

0

0

0

Ulceration

0F

0F

0

0

0

F: Observation confirmed with fluorescein

b: Both eyes were rinsed for one minute with lukewarm water 20 seconds after dosing

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for eye irritation according to EPA OPP 81-4. The test material is not considered to be an eye irritant and is not classified according to Regulation No. 1272/2008.