Registration Dossier

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:
circa 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test procedure employed was described in The Federal Register, Title 21, Part 191, para, 191.12. and was conducted briefly as follows: 0.1 ml of the test material was introduced into a cup formed by retracting the lower eyelid of the right eye of each of six albino rabbits. After introduction of the test substance, the eyelid was held closed for one second. The test animals were maintained without further treatment and their eyes were examined at 24, 48 and 72 hours after treatment. .
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Nitromethane
EC Number:
200-876-6
EC Name:
Nitromethane
Cas Number:
75-52-5
Molecular formula:
CH3NO2
IUPAC Name:
nitromethane
Details on test material:
No additional information available.

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No additional information available.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
After introduction of the test substance, the eyelid was held closed for one second. The test animals were maintained without further treatment and their eyes were examined at 24, 48 and 72 hours after treatment.
Observation period (in vivo):
Eyes were examined at 24, 48 and 72 hours after treatment. Examination of the treated eyes was aided by use of a hand-held slit lamp and spectacle lupes. After the 24-hr examination, a drop of fluorescein sodium opthalmic solution was placed into each subjects's eye to aid in the visualization of possible damage to the cornea. Responses of the eyes were graded by the Draize technique as modified and presented in Illustrated Guide for Grading Eye Irritation by Hazardous Substances, prepared by the Bureau of Scientific Research, Food and Drug Administration.
Number of animals or in vitro replicates:
6
Details on study design:
The test material (0.1 ml) was introduced into a cup formed by retracting the lower eyelid of the right eye of each of 6 albino rabbits. The eyelids were held closed for one second. Eyes were examined 24, 48 and 72 hours after treatment. A hand-held slit lamp and spectacle loupes were used to examine eyes. After the 24 hour examination, a drop of fluorescein sodium ophthalmic solution was placed in each eye to help identify corneal damage.

Responses of the eyes were graded by the Draize technique. Responses of the cornea and iris were given scores of 0-4 and 0-2, respectively. Conjuctival chemosis and redness were scored on scales of 0-4 and 0-3, respectively. The average corneal opacity, iris, chemosis and redness scores were determined for all six animals at each time point.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no irriitating effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0 - < 1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
< 1
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Corneal opacity and iridial scores were 0 for all animals at all time points. The chemosis score was < 1 in 4 animals and 1 in one animal at 24 hours. At 48 hours, chemosis scores of 1 were listed for 2 animals. At 72 hours, these scores were <1. All other chemosis scores were 0. At 24 hours, redness scores of <1 and 1 were listed for 2 animals. At 48 hours the score of <1 at 24 hours had resolved to 0, but the other score was still a 1. This score resolved to 0 at 72 hours. All other redness scores were 0. The average chemosis scores at 24, 48 and 72 hours were listed as <1. The average redness scores at 24, 48 and 72 hours were <1, <1 and 0.

There was no indication of ulceration or other surface lesions after instillation of fluorescein. The eyes of 3 rabbits showed signs of moderately excessive lacrimation at the 48 and 72 hour examinations.
Other effects:
No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The results reveal that treatment of the eyes of test rabbits with the test materials listed above caused no significant change in any of the parameters studied in the test for eye irritants.
Executive summary:

The eye irritation potential of nitromethane was examined. Slight irritation, which was considered to be not significant, was noted in the eyes of rabbits treated with nitromethane.