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EC number: 276-696-7 | CAS number: 72490-01-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Sep 1992 to 07 Sep 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
- EC Number:
- 276-696-7
- EC Name:
- Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
- Cas Number:
- 72490-01-8
- Molecular formula:
- C17 H19 N O4
- IUPAC Name:
- ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hra:(NZW)SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2745 – 3047 g
- Housing: individually housed in screen-bottom stainless steel cages in temperature- and humidity controlled quarters.
- Diet: a measured amount of Laboratory Rabbit Diet
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 44 ± 67
IN-LIFE DATES: From: 04 Sep 1992 To: 07 Sep 1992
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL:
- Amount applied: 0.04 g (0.01 mL weight equivalent) of the test material - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6 males / 3 females
- Details on study design:
- ANIMAL SELECTION
Six male and three female acclimated rabbits were selected and maintained during the study in the same manner as for the acclimation period. Variations from the prescribed environmental condition existed and were considered to have had no effect on the study outcome.
The animals' eyes were examined on the day before test material administration using sodium fluorescein dye procedures. Only those animals with no ocular injury or irritation were used. Animals were identified by number and corresponding ear tag. The rabbits were divided into two groups consisting of six rabbits in Group 1 and three rabbits in Group 2.
TREATMENT
Each rabbit received 0.04 g (0.1 mL weight equivalent) of the undiluted test material placed into the everted lower lid of the right eye, with the left eye serving as the untreated control. The upper and lower lids were gently held together for 1 second to prevent loss of material and then released. The eyes of the Group 1 rabbits remained unflushed following instillation of the test material. After 24 hours, the eyes were flushed with lukewarm tap water. The eyes of the Group 2 animals were flushed in the same manner for 1 minute starting 30 seconds after test material instillation.
OBSERVATIONS
Animals were weighed just before test material administration. The treated eyes of both groups were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment. Irritation was graded and scored according to the Draize technique (see Table 1 in 'Any other information on materials and methods incl. tables').
TERMINATION
At termination of the experimental phase, all animals were euthanised.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 to #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1 to #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #2, #4, #5, #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #3
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 to #6
- Remarks:
- Group 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance, when evaluated for its primary eye irritation potential in rabbits, produced only slight to moderate conjunctival irritation in eyes not receiving a washout until 24 hours after the treatment. In treated eyes receiving a washout approximately 30 seconds after instillation, the test material produced only slight conjunctival irritation. All treated eyes in both groups had returned to a normal appearance by 72 hours after treatment.
Any other information on results incl. tables
Table 2. Individual Eye irritation Scores Group 1
Animal Number |
Sex |
Cornea |
Iris |
Conjunctivae |
Total score* |
|||
|
|
A |
B |
C |
D |
E |
F |
|
1 hour |
||||||||
1 |
male |
0 |
0 |
0 |
1 |
1 |
0 |
4.0 |
2 |
male |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
3 |
male |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
4 |
male |
0 |
0 |
0 |
2 |
1 |
0 |
6.0 |
5 |
female |
0 |
0 |
0 |
2 |
1 |
1c |
8.0 |
6 |
female |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
|
|
|
|
|
|
Mean |
|
5.3 |
24 hours |
||||||||
1 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
2.0 |
3 |
male |
0 |
0 |
0 |
1 |
0 |
0 |
4.0 |
4 |
male |
0 |
0 |
0 |
2 |
0 |
0 |
2.0 |
5 |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
6 |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
|
|
|
|
|
|
Mean |
|
2.0 |
48 hours |
||||||||
1 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
3 |
male |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
4 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
5 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
6 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
|
|
|
|
Mean |
|
0.3 |
72 hours |
||||||||
1 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
3 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
4 |
male |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
5 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
6 |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Cornea
A - Degree of opacity
B - Area of involvement
Iris
C - Degree of iridal irritation
Conjunctivae
D - Redness
E - Chemosis
F - Discharge
* Total score = (A x B x 5) + (C x 5) + [(D + E + F) x 2].
c = Clear discharge.
Table 3. Individual Eye irritation Scores Group 2
Animal Number
|
Sex
|
Cornea
|
Iris |
Conjunctivae
|
Total score
|
|||
|
|
A |
B |
C |
D |
E |
F |
|
1 hour |
||||||||
1 t |
female |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
2 t |
female |
0 |
0 |
0 |
1 |
1 |
1c |
6.0 |
3 t |
female |
0 |
0 |
0 |
1 |
1 |
0 |
4.0 |
|
|
|
|
|
|
mean |
|
5.3 |
24 hour |
||||||||
1 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
2 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
3 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
|
|
|
|
|
|
mean |
|
2.0 |
48 hours |
||||||||
1 t |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
2 t |
female |
0 |
0 |
0 |
1 |
0 |
0 |
2.0 |
3 t |
female |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
|
|
|
|
mean |
|
0.7 |
Cornea:
A - Degree of opacity
B - Area of involvement
Iris:
C - Degree of iridal irritation
Conjunctivae:
D - Redness
E - Chemosis
F - Discharge
* Total score = (A x B x 5) + (C x 5) + [(D + E + F) x 2].
c = Clear discharge
t = No pain response after test material instillation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study, it was concluded that test substance was considered to be not irritating to the eyes of rabbits.
- Executive summary:
In a primary eye irritation study (EPA 81-4) performed following GLP principles, 0.1 mL of the undiluted test substance was instilled into the everted lower lid of the right eyes of nine rabbits, six with treated eyes unwashed and flushed after 24 hours, while three animals were flushed in the same manner for 1 minute starting 30 seconds after test material instillation. The left eye remained untreated and served as a control. Observations were made 1 hour, 24 hours, 48 hours and 72 hours after instillation of the test substance. Ocular irritation was evaluated by the Draize scale method.
The mean scores, calculated from the 24, 48 and 72 hour readings, for the 6 tested animals with eyes washed at 24 hours were 0 for cornea, 0 for iritis, 0.4 for conjunctiva redness, and 0 for oedema of conjunctiva. The reactions were fully reversible within the observation period. The mean scores calculated from the 24, 48 and 72 hour readings for each of the 3 tested animals with eyes washed at 30 seconds after treatment were also below the threshold values for all effects.
Under the conditions of this study, the test substance was considered to be not irritating to the eyes of rabbits.
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