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EC number: 204-688-5 | CAS number: 124-19-6
Eye irritation
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:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study predates GLP
Test material
- Reference substance name:
- Nonanal
- EC Number:
- 204-688-5
- EC Name:
- Nonanal
- Cas Number:
- 124-19-6
- Molecular formula:
- C9H18O
- IUPAC Name:
- nonanal
Constituent 1
- 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.
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