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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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study, purity of the test material is unknown.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
2-Nitropropane was evaluated for potential primary eye irritation using six New Zealand White rabbits. Each rabbit was administered 0.1 ml of the test article to the conjunctival sac of one eye. The untreated contra lateral eye of each rabbit served as a control. Treated and untreated eyes were examined and ocular irritation was scored according to the Draize method at 24, 48 and 72 hours after test article instillation.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material was used as supplied by WR Grace and Company.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Six young adult New Zealand White rabbits weighing 2-3 kg were acclimated for at least 5 days before use. Food and water were supplied ad libitum. Eyes were examined with sodium fluorescein and a slit light equipped with a cobalt blue filter prior to dosing to verify the absence of pre-existing ocular lesions.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated contra lateral eye of each rabbit served as a control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
2-Nitropropane was evaluated for potential primary eye irritation using six New Zealand White rabbits. Each rabbit was administered 0.1 ml of the test article to the conjunctival sac of one eye. The untreated contra lateral eye of each rabbit served as a control. The animals were observed twice daily for mortality at least 5 hours apart. Treated and untreated eyes were examined and ocular irritation was scored according to the Draize method at 24, 48 and 72 hours after test article instillation.

The test was considered positive if four or more of the animals had a positive reaction. If only one animal was affected, the test was negative. If two or three animals were affected, the test was to be repeated. The second test was to be considered positive if 3 or more animals had a positive reaction. If one or two animals were affected, the test was to be repeated again. If any animal in the third test had a positive reaction, the material was regarded as an irritant.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hour
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hour
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The mean eye irritation score was 1.0 +/- 1.7 at 24 hours. At 48 hours, the mean score was 0.3 +/- 0.8. This is consistent with a classification of "minimally irritating to eyes".

The incidence of positive ocular responses in all animals was 0. Scores for conjunctival redness and chemosis, corneal opacity and effects on the iris were not listed. According to the protocol, a corneal opacity score of 1 was considered to be a positive response, but conjuctival redness, chemosis and discharge scores of 1 were not. Since no positive responses were noted in any of the animals, it is likely that the minimal effects observed in some eyes were limited to the conjunctiva. According to 16 CFR Part 1500, 2-nitropropane was not considered a primary irritant.

The untreated eyes of all animals appeared normal at all observations.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
2-Nitropropane is slightly irritating to the eyes of rabbits.
Executive summary:

None