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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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets National standards method with acceptable restrictions.

Data source

Referenceopen allclose all

Reference Type:
other: 1,2,3-trinitroglycerin (TNG) CAS RN. 55-63-0 Summary of SIDS results
Title:
Unnamed
Year:
1985
Reference Type:
publication
Title:
Methods for the study of irritation of toxicity of substances applied to the skin and mucous membranes.
Author:
Draize , J. H., et al.
Year:
1944
Bibliographic source:
J. Pharm. Exp. Ther., 82, 377-390

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16CFR 1500.42(FHSA) (CFR, 2001).
Principles of method if other than guideline:
The protocol differed from 16 CFR 1500.42 in the following ways:1. The treated eyes of 3/6 rabbits were washed one minute after instillation of the test material.2. If adverse eye effects, or other adverse effects, were present seven days post treatment, the eyes would be evaluated again at 14 days post-exposure.3. The general health of the animals also was evaluated each time the eyes were evaluated. Any additional clinical signs were recorded and also included in the report of the study. The eyes also were evaluated for any sign of systemic effects, mydriasis, or miosis.4. Draize (Draize, 1944) numerical scoring was used.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol trinitrate
EC Number:
200-240-8
EC Name:
Glycerol trinitrate
Cas Number:
55-63-0
Molecular formula:
C3H5N3O9 C3H5(NO3)3
IUPAC Name:
propane-1,2,3-triyl trinitrate
Details on test material:
- Test material was neat NG, isolated from an ethanol solution immediately prior to testing. The ethanol solution was from commercial production
(usually 99+ per cent pure). However, sponsor did not supply an analysis.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: regular supplier

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
3 animals 1 min (eyes rinsed with water), 3 animals up to 7 days ( without rinsing with water)
Observation period (in vivo):
1 hr, 24 hrs, 48 hrs, 72 hrs
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): The treated eyes of 3/6 rabbits were washed 1 min after instillation of the test materialSCORING SYSTEM: Draize (Draize, 1944) numerical scoring was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
conjuctival redness
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
conjuctival redness
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
conjuctival redness
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
other: conjuctival score conjuctival redness
Basis:
animal: washed eye (1 of 3)
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal: washed eye (1 of 3)
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
unwashed eye (2 of 3)
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: washed eye (1 of 3)
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed and unwashed eye
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: All rabbit eyes were normal when examined 24/48/72 hours and 7 days post treatment.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: unwashed eye (1 of 3)
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
The only effects observed were at one hour post-dosing. They were: Draize rating "1" conjunctival discharge in the treated eyes of 2/3 rabbits whose eyes were not washed and in 3/3 rabbits whose eyes were washed. Rating "1" conjunctival chemosis was seen in 1/3 rabbits whose eyes were washed, and conjunctival redness was seen in another of the rabbits whose eye was washed after treatment. There was no miosis, mydriasis, other ocular effects, or evidence of systemic effects in any of the rabbits treated. All rabbit eyes were normal when examined at all other post-treatment times.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
Undiluted TNG is not an eye irritant as defined by Draize scoring or by 16 CFR1500.42 (Cerven, D. R., 1985).