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EC number: 220-260-0 | CAS number: 2691-41-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 22 to 26 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no reading at 48 h
- Principles of method if other than guideline:
- Three male and three female rabbits were tested in this study, the test substance were applied to both intact and abraded skin of each animal. The patches were left in position for 24 h. The test sites were scored immediately after removed and again after 48 h to give the required 24 h and 72 h readings.
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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): 20°C (extremes of 16°C-23°C)
- Humidity (%): 64% (extremes of 60%-74%)
No additional data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The rabbits were prepared by clipping the skin of the back and flanks of all animals free from hair and 2 of the 4 test areas on each rabbit were abraded using a 'sterilin' blood lancet.
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
No additional data - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male and 3 female
- Details on study design:
- TEST SITE
- Area of exposure: back and flanks
- Type of wrap if used: The patches were covered by an overlapping patch of impermeable plastic adhesive tape. The whole area was then bound by Sleek occlusive tape wrapped round the entire trunk of the animal.
SCORING SYSTEM: Draize
No additional data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24 and 72 hours
- Score:
- 0.58
- Max. score:
- 2
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance in physiological saline elicited very slight to well defined erythema at both abraded and non-abraded sites on 3/6 rabbits. Remaining rabbits showed no response to test substance at 24 h. At 72 h erythema persisted in one rabbit at both the abraded and non-abraded sites.
Very slight to slight oedema was noted on both abraded and non-abraded sites on 2 rabbits, the remaining animals showing no response on either site at 24 h. At 72 h very slight oedema persisted in one rabbit at the non-abraded site. - Other effects:
- No information provided
Any other information on results incl. tables
|
Rabbit No./sex |
Skin score |
|
Erythema |
Oedema |
||
24 hours |
1♂ |
0 |
0 |
2♀ |
2 |
2 |
|
3♂ |
1 |
0 |
|
4♀ |
0 |
0 |
|
5♂ |
0 |
0 |
|
6♀ |
2 |
1 |
|
72 hours |
1♂ |
0 |
0 |
2♀ |
2 |
1 |
|
3♂ |
0 |
0 |
|
4♀ |
0 |
0 |
|
5♂ |
0 |
0 |
|
6♀ |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is a mild skin irritant to New Zealand White rabbit. However under the Regulatin (EC) No 1272/2008 it is not classified for skin irritation
- Executive summary:
Under the Regulatin (EC) No 1272/2008 the test substance, tested as 60% w/w HMX in physiological saline, is not classified for skin irritation.As per the table below the mean score for erythema/eschar or for oedema wasn't between 2.3 and 4.0 calculated between two time points: 24 and 72 hours.
Animal no. Erythema/Eschar
(mean score)Oedema
(mean score)1 0 0 24/72hrs 2 2 1.5 3 0.5 0 4 0 0 5 0 0 6 1 0.5
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