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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:
2008-12-15 to 2008-12-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
4-hydroxy-3,5-dimethoxybenzonitrile
Cas Number:
72684-95-8
IUPAC Name:
4-hydroxy-3,5-dimethoxybenzonitrile
Test material form:
solid
Specific details on test material used for the study:
- Composition of test material, percentage of components: syringonitrile 99.8%
- Expiration date of the lot/batch: May 2010
-Physical description: pale yellow powder
-solubility: soluble in water
-stability: test substance was expected to be stable for the duration of the testing.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Received from Robinson Services, Inc, Clemmons, NC, on Dec. 10, 2008
- Age at study initiation: young adult
- Housing: singly housed in suspended stainless steel cage
- Diet (e.g. ad libitum): pelleted Purina Rabbit Chow
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 38-44%
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
One-tenth of a mililiter (0.06 grams) of the test substance was instilled to the right eye.
Duration of treatment / exposure:
After the instillation, the upper and lower lids were gently held together for about one second before releasing to minimize loss of the test substance.
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
-At the 24-hour scoring period, one drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit and the eyes were rinsed with physiological saline and then evaluated for corneal opacity with an UV-light.

SCORING SYSTEM:
Kay and Calandra scheme for classifying eye irritants
Ocular irritation evaluated in accordance with Draize et al.

TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite). Corneal opacity evaluated with an UV-light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
17
Max. score:
17
Remarks on result:
other: includes score for 1-hour reading
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: includes score for 1-hour reading
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
>= 0 - <= 2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: score of 2 for 1-hour reading
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: score of 2 for 1-hour reading
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
>= 0 - <= 1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: score of 1 for 1-hour reading
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: score of 0 for 1-hour reading
Irritant / corrosive response data:
One hour after the instillation, two treated eyes exhibited corneal opacity and all three treated eyes exhibited iritis and conjunctivitis. The overall incidence and severity of irritation decreased gradually with time. All animals were free of ocular irritation within 72 hrs.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this study, the test substance is mildly irritating to the eye.
Executive summary:

The objective of this study was to assess the ocular irritation potential of Mediator SNP (4-hydroxy-3,5-dimethoxybenzonitrile). One-tenth of a milliliter (0.1 mL) of Mediator SNP was instilled into the right eye of three rabbits. The left eye remained untreated and served as control. Ocular irritation was evaluated using a high-intensity white light (Mag Lite) at 1, 24, 48 and 72 hours post-instillation. At the 24-hour scoring period, one drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit and the eyes were rinsed with physiological saline and then evaluated for corneal opacity with an UV-light.

All animals appeared healthy and active during the study. One hour after Mediator SNP instillation, corneal opacity was noted in 2 out of 3 rabbits and iritis and conjunctivitis were recorded in all three animals. The overall incidence and severity of irritation decreased gradually with time and no ocular irritation was noted at the 72-hour scoring period. The maximum mean score of Mediator SNP was 17.0 out of a possible 110. Using the Kay and Calandra scheme for classifying eye irritants, Mediator SNP is classified as “mildly irritating” to the eyes.