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Diss Factsheets

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:
Dosing initiated: February 3 1982, Study termination: February 17 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
7,7-dimethyl-3-oxa-6-azaoctan-1-ol
EC Number:
400-390-6
EC Name:
7,7-dimethyl-3-oxa-6-azaoctan-1-ol
Cas Number:
87787-67-5
Molecular formula:
Hill formula: C8 H19 N O2 CAS formula: C8 H19 N O2
IUPAC Name:
2-[2-(tert-butylamino)ethoxy]ethan-1-ol
Details on test material:
- Name of test material (as cited in study report): MRD-82-10
- Physical state: Colorless liquid
- Analytical purity: Assumed to be 100% ode purposes of dosing
- Storage condition of test material: Room temperature in airtight container.

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: Approx 12 weeks
- Weight at study initiation: 2.6 to 3.6 kilograms
- Housing: Individually housed in suspended stainless steel cages (27 x 22 x 14 inches)
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow (ad libitum)
- Water (e.g. ad libitum): Automatic watering system (ad libitum)
- Acclimation period: 30 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Maintained range of 65 to 71 degrees Fahrenheit during study.
- Humidity (%): Maintained range of 40 to 70% during study.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark by automatic timer.


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye of the animals served as the control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test material was instilled into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for approximately one second to prevent loss of the material. The treated eyes of six animals remained unwashed. Twenty to thirty seconds after instillation, the treated eyes of the three remaining animals were rinsed for one minute with sixty milliliters of lukewarm tap water. The control eyes of these animals were not washed.



VEHICLE
Not applicable.
Duration of treatment / exposure:
14 days.
Observation period (in vivo):
14 days.
Number of animals or in vitro replicates:
9.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated eyes of three animals were rinsed for one minute with sixty ml of lukewarm water.
- Time after start of exposure: Twenty to thirty seconds after installation,


SCORING SYSTEM: Observations for signs of ocular irritation were made at approximately 1, 4, 24, 48 and 72 hours and 4 and 7 days after treatment. Since there were signs of irritation on Day 7, observations were made on Day 14.
Ocular reactions were graded according to the Draize Scale for Scoring Ocular Lesions.


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
other: necrosis observed in number of test animals (out of 12)
Time point:
other: All timepoints
Score:
12
Max. score:
12
Reversibility:
not reversible
Remarks on result:
other: Necrosis was observed in all animals at all intervals.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #8
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #8
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #8
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #9
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #9
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
chemosis score
Basis:
animal: #9
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
cornea opacity score
Basis:
animal: #7
Time point:
24/48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal: #7
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal: #9
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
> 2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Remarks:
Score not attributed due to severity of response
Irritation parameter:
iris score
Basis:
animal: #9
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #8
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal: #9
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Ocular reaction to the test material was severe. Necrosis was observed in all animals at all intervals. In many cases the eye could not be fully evaluated due the severity of response.
Conjuctival responses included: redness scores of ‘3-4’, chemosis scores of ‘2-4’ lending to an increase in severity over time, discharge scores of ‘0-3’, ulceration and necrosis, with seven of the nine rabbits clearing of ulceration after the first two to three observation period.
 Iridial responses could not be evaluated at all in four animals, one being a washed animal, or were either scored at ‘2’ or not evaluated for the remaining five animals.
 Corneal responses included; opacity scores of ‘4’ for one unwashed animal, and for remaining animals ranged from ‘2-4’ or could not be evaluated at some intervals due to the severity of response. Area scores ranged from ‘1-4’. Ulceration of the cornea was scored from ‘0-4’, or could not be evaluated for some intervals due to the severity of response.
Other effects:
Corneal prolusions, deterioration of eyelids, eyes held shut by discharge and discharges of red, white and yellow-green were along the supplement observations noted.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ocular reaction to the test material was severe. Necrosis was observed in all animals at all intervals. In many cases the eye could not be fully evaluated due the severity of response.
Executive summary:

The eye irritation potential of the test substance was evaluated following a single application to the right eye of nine New Zealand White rabbits. Three of the nine animals had their eyes flushed with lukewarm water for approximately one minute, starting at about 20 to 30 seconds after instillation. For ocular lesions were performed at 1, 4, 24, 48 and 72 hours and at Days 4, 7 and 14 post-instillation. Ocular reactions were graded according to the Draize Scale for Scoring Ocular Lesions.

 

Ocular reaction to the test material was severe. Necrosis was observed in all animals at all intervals. In many cases the eye could not be fully evaluated due the severity of response. Corneal prolusions, deterioration of eyelids, eyes held shut by discharge and discharges of red, white and yellow-green were along the supplement observations noted.

 

Conjuctival responses included: redness scores of ‘3-4’, chemosis scores of ‘2-4’ lending to an increase in severity over time, discharge scores of ‘0-3’, ulceration and necrosis, with seven of the nine rabbits clearing of ulceration after the first two to three observation period.

 

Iridial responses could not be evaluated at all in four animals, one being a washed animal, or were either scored at ‘2’ or not evaluated for the remaining five animals.

 

Corneal responses included; opacity scores of ‘4’ for one unwashed animal, and for remaining animals ranged from ‘2-4’ or could not be evaluated at some intervals due to the severity of response. Area scores ranged from ‘1-4’. Ulceration of the cornea was scored from ‘0-4’, or could not be evaluated for some intervals due to the severity of response.