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EC number: 220-260-0 | CAS number: 2691-41-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 to 30 July 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study run to a reliable method but not to GLP and no guideline followed
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Three male and three female rabbits were tested in this study. The test substance placed in to the right eye, the other eye remained untreated to serve as a control. The ocular reaction was recorded at 1 h, 24 h and 2, 3 and 7 days after treatment.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine
- EC Number:
- 220-260-0
- EC Name:
- Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine
- Cas Number:
- 2691-41-0
- Molecular formula:
- C4H8N8O8
- IUPAC Name:
- 1,3,5,7-tetranitro-1,3,5,7-tetrazocane
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cheshire Rabbits Farms
- Weight at study initiation: 2.5-3.0 kg
- Housing: They were housed individually in cages with a grid floor, beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): The animals were fed on Spratt's Rabbit Diet, ad libitum.
- Water (e.g. ad libitum): Water was allowed ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (extremes of 16°C-23°C)
- Humidity (%): 65% (extremes of 60%-78%)
No additional data
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
No additional data - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 male and 3 female
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: The eyes were examined for irritation using standard illumination.
No additional data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: One treated eye showed slight redness at 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material elicited no corneal or iridial response at any stage of the test.
Slight redness of the conjunctivae was noted in 2/6 treated eyes at 1 h. One treated eye showed slight redness at 7 days. 5/6 treated eyes had returned to normal at 24 h. - Other effects:
- Test material was evident as aggregations in the inner corner of the eye at 1 h in all treated eyes and in 1/6 treated eyes at 24 h.
Any other information on results incl. tables
|
Scores |
||||||
Time after administration |
Rabbit No. and Sex |
7♂ |
8♀ |
9♂ |
10♀ |
11♂ |
12♀ |
1 hour |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
1 |
0 |
0 |
0 |
0 |
1 |
|
Conjunctivae chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 hours |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 hours |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 hours |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 days |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae redness |
0 |
1 |
0 |
0 |
0 |
0 |
|
Conjunctivae chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is a mild irritant to eyes. However under the Regulatin (EC) No 1272/2008 it is not classified for eye irritation
- Executive summary:
Under the Regulatin (EC) No 1272/2008, the test substance tested as HMX in water, is not classified for skin irritation. As per the table below the mean score for corneal opacity or iritis wasn't ≥ 1 and/or conjunctival redness or oedema (chemosis) wasn't ≥ 2
calculated between the time points: 24, 48 and 72 hours.
Animal no
Mean scores at 24, 48 and 72 hrs)
Cornea
Iris
Conjunctivae
redness
chemosis
discharge
33
0
0
0.33
0
0
34
0
0
0.17
0
0
35
0
0
0
0
0
36
0
0
0
0
0
37
0
0
0.17
0
0
38
0
0
0.33
0
0
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