Registration Dossier

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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, comparable to a guideline study
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:
comparable to a guideline study
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:
Source: Ace Animals, Inc., Boyertown, PA

The animals (6 New Zealand White rabbits; 2-3 kg in weight) 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: left eye served as the control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
The test material (0.1 ml) was instilled into the right conjunctival sac of each rabbit and the lids were held together for one second and released. The animals were observed twice daily for mortality at least 5 hours apart. Primary eye irritation was evaluated 24, 48 and 72 hours after the test material was administered. The cornea, iris and conjunctiva were scored separately according to the method of Draize. The total maximum score was 110. 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
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hour
Score:
0.83
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hour
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hour
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hour
Score:
0
Max. score:
4
Irritant / corrosive response data:
Conjunctival redness and chemosis scores of 1 were listed for 5/6 and 4/6 treated eyes (respectively) at 24 hours. All other scores (including those for control eyes) were 0. The total eye irritation score for each animal was 4, 2, 0, 4, 4, and 4. The mean eye irritation score was 3.0 +/- 1.7 at 24 hours. This is consitent with a classification of "minimally irritating to eyes".

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. Therefore, no positive responses were noted in any of the animals. According to 16 CFR Part 1500, 1-nitropropane was not considered a primary irritant.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
other: not classifiable
Remarks:
Criteria used for interpretation of results: other: EU GHS
Conclusions:
The mean eye irritation score was 3.0 +/- 1.7 at 24 hours. This is consistent with a classification of "minimally irritating to eyes". According to EU GHS classification, 1-NP is not classifiable.
Executive summary:

None