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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14.04.1986 to 05.05.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-960-2
EC Name:
-
Cas Number:
27610-48-6
Molecular formula:
C16H16O4
IUPAC Name:
2-[({6-[(oxiran-2-yl)methoxy]naphthalen-1-yl}oxy)methyl]oxirane
Test material form:
liquid: viscous
Details on test material:
Storage: ambient temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
-Six New Zealand White strain rabbits in the weight range 2.0 to 2.8 kg, prior to treatment on Day 1 and approximately 9 to 13 weeks were obtained from Froxfield Rabbits, Petersfield, Hampshire. The rabbits were acclimated to the laboratory environment.
-Each animal was identified by a numbered aluminium tag
-Rabbits were individually housed in metal cages.
-They had free access to tap water and SDS Standard Rabbit Diet.
-Animal room temperature was maintened at 19°C and relative humidity at 30-70%
-Air exchange was maintained at 19 air changes per hour and lighting was controlled to give 12 hours artificial light (0700-1900 hours) in each 24 hour period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
-A 0.1 ml aliquot of EPICLON EXA 4032.
Duration of treatment / exposure:
After application, the eyelids were then gently held together for one second before releasing.
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3, 4, 7, 14 and 21 Days after instillation.
Number of animals or in vitro replicates:
Six New Zealand White strain rabbits.
Details on study design:
SCORING SYSTEM:
Cornea: degree of density (area most dense taken for reading)
-No ulceration or opacity: 0
-Scattered or diffuse areas of opacity (other than slight dulling of norma lustre), details of iris cearly visible: 1*
-Easily discernible translucent areas, details of iris slightly obscured: 2*
-Nacrous areas, no details of iris visible, size of pupil barely discernible: 3*
-Opaque cornea, iris not descernible through the opacity: 4*

Iris.
-Normal: 0
-Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection of any thereof, iris still reacting to light (sluggish reaction is positive): 1*
-No reaction to light, haemorrhage, gross destruction (any or all of these): 2*

Conjunctivae-redness (refers to palpebral and bulbar conjunctivae cornea and iris)
-Blood vessels normal: 0
-Some blood vessels definitely hyperaemic (injected): 1
-Diffuse, crimson colour, individual vessels not easily discernible: 3*

Chemosis (lids and/or nictitating membranes)
-No swelling: 0
-Any swelling above normal (includes nictitating membranes): 1
-Obvious swelling with partial eversion of lids: 2*
-Swelling with lids about half-closed: 3*
-Swelling with lids more then half-closed: 4*

*: Intepreted as a positive effect.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24h - 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24h - 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24h - 72h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24h - 72h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24h - 72h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24h - 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24h - 72h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24h - 72h
Score:
2.66
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: mean 24h - 72h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: mean 24h - 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean 24h - 72h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: mean 24h - 72h
Score:
2.66
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24h - 72h
Score:
2.66
Max. score:
3
Remarks on result:
other: Due to the severity of the reactions, this animal was killed four days after instillation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: mean 24h - 72h
Score:
2.66
Max. score:
3
Remarks on result:
other: Due to the severity of the reactions, this animal was killed four days after instillation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: mean 24h - 72h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: mean 24h - 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean 24h - 72h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: mean 24h - 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
-All six animals gave a "positive" response.
-Due to the severity of the reactions, two animals were killed four days after instillation.
-Corneal opacities developed in five animals. Vascularisation of the cornea was seen in one animal.
-Iridial inflammation was seen in the three animals.
-A diffuse beefy red colouration of the conjunctivae was seen in all six animals accompanied by considerable swelling with the eyes about or more than half closed.
-Areas of necrosis on the eyelids were seen in one animal.
-The eyes of the remaining four animals were normal 7, 14 or 21 days after instillation.
Other effects:
Areas of necrosis on the eyelids were seen in one animal.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
In conclusion, instillation of EPICLON EXA 4032 into the rabbit eye elicited a positive response in all six treated animals according to nT.S.C.A test criteria.
Executive summary:

This study was designed to assess eye irritation potential. The study was performed according Guidelines as described in the Federal Register, Vol. 50, N° 188, Part II of 27 September 1985, Section 798.4500_Primary Eye Irritation.

Six New Zealand White strain rabbits were used to perfoemed this study.

A 0.1 ml aliquot of EPICLON EXA 4032 was placed into the lower everted lid of one eye of each animal.

Examination of the eyes was made after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days afetr instillation. Observation of the eyes was aided by the use of a handle torch.

In conclusion, instillation of EPICLON EXA 4032 into the rabbit eye elicited a positive response in all six treated animals according to nT.S.C.A test criteria.