Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptble, Well-documented study report similar or equivalent to OECD 405. glp

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
MCP 968 is a straw colored homogenous liquid. The MEHSL CRU number is 90163. This substance is stable for 6 month at 20C with an expiration date of 8/30/1990.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male and three female young adult New Zealand White rabbits obtained form Hazleton Research Products, Inc. (Denver, Pa) were used in this study. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 68-71F with a relative humidity of 44-66%

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye was test eye, right eye was control
Amount / concentration applied:
0.1 ml of the test substance was instilled into the left conjunctival sac of six animals.
Duration of treatment / exposure:
After insitillation the eyelids were gently held together for approximately 1 second. Both eyes were grossly examined and the test scored according to the Draize method at 1, 24, 48, and 72 hours post-dosing.
Observation period (in vivo):
After insitillation the eyelids were gently held together for approximately 1 second. Both eyes were grossly examined and the test scored according to the Draize method at 1, 24, 48, and 72 hours post-dosing. Plastic collars were placed on each animal after instillation to prevent mechanical irritation of the eye. The condition of each animal (live, dead, moribund) was checked once daily in the morning.
Number of animals or in vitro replicates:
six (3/sex)
Details on study design:
Both eyes were grossly examined and the test scored according to the Draize method at 1, 24, 48, and 72 hours post-dosing. All eyes were stained with 2% sodium fluorescein during the 24 hour evaluation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 24/48/72 hr average
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h average
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24/48/72 hr average
Score:
0.7
Max. score:
1.2
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 72 hours was the last observation point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hr average
Score:
0.5
Max. score:
1
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 72 hours was the last observation point
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
0
Other effects:
The following clinical observations were noted in one or more animals: soft stool, decreased fecal output, and decreased food consumption.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the test material were 0, 0, 0.7, and 0.5, respectively. These findings do not warrant classification of the test material as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The test material was administered to one eye of six New Zealand White rabbits to assess for ocular irritation; the other eye was used as a control. Clinical observations were made 1 and 4 hours immediately after treatment and daily thereafter for 3 days. Ocular damage was assessed and scored according to the Draize method. Slight irritation was noted at 1, 24, 48, and 72 hours post dosing. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the test material were 0, 0, 0.7, and 0.5, respectively. These findings do not warrant classification of the test material as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.