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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
72 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
416-740-6
EC Name:
-
Molecular formula:
Can vary from C30H53O4 (di-C11 rxn product) to C36H65O4 (di-C14 rxn product)
IUPAC Name:
Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich
Details on test material:
MCP 1440 is a colorless homogeneous liquid. This material as stated in the Product Physical And
Chemical Data sheet is a terephthalate ester (di-tridecyl terephthalate).

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 from Hazleton Research Products, Inc. (Denver, PA.) were used in this study. The animals were identified by individual ear tag and cage cards. The temperature of the study room was maintained at 70-72 degrees F with a relative humidity of 44-61%.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye tested, other used as control
Amount / concentration applied:
0.1 mL of undiluted test article
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three male and three female rabbits
Details on study design:
Both eyes were grossly examined for ocular defects and/or irritation on the day prior to instillation of the test substance. The left eye was designated the test eye and the right eye as the control. 0.1 ml of the test substance was instilled with a 1 cc syringe into the left conjunctival sac of six animals (3 per sex). After instillation the eyelids were gently held together for one second. Both eyes were grossly examined and the test eye scored according to the Draize method at 1, 24, 48, and 72 hours post-dosing.

All test eyes were stained with 2% sodium fluorescein during the 24-hour evaluation. Plastic collars were placed on each animal after instillation to prevent mechanical irritation of the eye. The collars were removed 24 hours after instillation. Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter. The condition of each animal (live, dead, moribund) was checked at least once daily in the morning.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 1 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Additional time point of 1 hour based on guidance protocol.
Irritant / corrosive response data:
Slight irritation was noted at 1 hour and diminished over the remainder of the study.
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 Draize eye irritation scores for 1,4-benzenedicarboxylic acid, di-C11-14 isoalkyl ester, C13-rich are not greater than or equal to 2 for conjunctival redness or oedema, nor greater than or equal to 1 for corneal opacity or iritis, at 24, 48, and 72 hours. This finding does not warrant the classification of 1,4-benzenedicarboxylic acid, di-C11-14 isoalkyl ester, C13-rich as an eye 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:

Three male and three female New Zealand white rabbits received 0.1 mL instillations of 1,4-benzenedicarboxylic acid, di-C11-14 isoalkyl ester, C13-rich into one eye and were observed at 1, 24, 48, and 72 hours following treatment to assess eye irritation. Slight irritation was observed following treatment, and fully resolved in all animals except one by 72 hours. No effects were observed on the cornea or iris. Some redness (highest mean value of 1.66 observed at 1 hour), chemosis (highest mean value of 1.16 observed at 1 hour), and discharge (highest mean value of 2 observed at 1 hour) were noted. This finding does not warrant the classification of 1,4-benzenedicarboxylic acid, di-C11-14 isoalkyl ester, C13-rich 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.