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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Well conducted study according to that prescribed by Consumer Product safety Commission of the USA in The Code of Federal regulations, Title 16, section 1500.42. The principle of the test method is similar to the principle of the OECD Guideline 405 and no deviations have been reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Consumer Product safety Commission of the USA in The Code of Federal regulations, Title 16, section 1500.42
Deviations:
no
Principles of method if other than guideline:
The ocular reactions were scored by the method described by J.H. Draize in "Appaisal of the Safety of Chemicals in Food, Drugs and Cosmetics".
The test material is placed in one of the eye while the other one serves as control. The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
EC Number:
245-950-9
EC Name:
N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
Cas Number:
23949-66-8
Molecular formula:
C18H20N2O3
IUPAC Name:
N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)ethanediamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Six albino rabbits are used for each test substance.
Animal facilities were mantained so that to exclude sawdust, wood chips or other extraneous materials that might produce eye irritation.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required since the control was the eye not treated with the test item.
Amount / concentration applied:
75 mg pf the test item powder was instilled into one eye of each animal.
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Single application. Instillation of 75 mg of the test material into one eye of the animal by gently gently putting the lower lid away from the eyeball to form a cup into which the test item is dropped. The lids are then getly held together for one second and the animal is released.The other eye remained untreated to serve as a control for the treated eye. Each eye was graded according to the criteria reported in "illustration".

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 days
Score:
0.8
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 2 days
Score:
0.8
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 days
Score:
0.8
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0.7
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applixcable
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritant / corrosive response data:
Mild conjunctival inplammation only was observed in three animals.
The three remaining animals did not show any observable response to treatment throughout the 7 day observation period.
Other effects:
not reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test item is considered to be "non-irritant" to the rabbit eye when classified as recommended by the ETAD Sub-commitee for Toxicology.
Executive summary:

The potential for eye irritation following exposure to the test item was assessed in 6 albino rabbits (75 mg of unchanged test item). Observations were carried out at regular intervals over 7 days following exposure. Mild conjunctival inplammation only was observed in three animals. The three remaining animals did not show any observable response to treatment throughout the 7 day observation period.

This eye irritation information for euthe test item is based on the standard Draize scale which has an overall score based on a 110 point rating scale. This rating scale is not directly compatible with Regulation (EC) No 1272/2008, Annex I section 3.3 classification criteria. However, based on guidance from various agencies, N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide appears to be "non-irritant" to the rabbit eye when classified as recommended by the ETAD Sub-commitee for Toxicology.