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EC number: 200-240-8 | CAS number: 55-63-0
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:
- 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:
- 1 985
- 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:
- 1 944
- 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
- 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.
Constituent 1
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).
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