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EC number: 200-240-8 | CAS number: 55-63-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1.4.1974-31.5.1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets National standards method with acceptable retrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register, Title 21-Food and Drugs, Part 191,11 "Method of Testing Primary Irritant Substances" and Part 191,12 "Test for Eye Irritants" (1974).
- GLP compliance:
- not specified
- Remarks:
- Unlikely.
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:
- - Name of test material (as cited in study report): trinitroglycerin (TNG, NG)
- Substance type: organic substance
- Physical state: a 10% mixture in lactose
- Source: ICI America-Atlas Chemical Division (Chicago Illinois)
- Analytical purity: 9.72 % +/- 0,09% in lactose
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Sma´l Stock Industries (Pea Ridge, Arkansas)- Housing: metal cages with wire bottoms- Diet (e.g. ad libitum): Purina rodent chow ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 23.9 +/- 2.8 oC- Humidity (%): 50 +/- 10%- Photoperiod (hrs dark / hrs light): photoperiod of 12 hours
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- other: peanut oil
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL- Concentration (if solution): 9.72%VEHICLE- Concentration (if solution): 25% peanut oil and 67.21% lactose
- Observation period:
- 24 h, 72 h
- Number of animals:
- Six rabbits with intact and abraded skin.
- Details on study design:
- SCORING SYSTEM:The compounds are classified as follows:> 0.2 over controls is mild irritant> 2.5 over controls is moderate irritant> 5.0 over controls is severe irritant
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0.46
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- ca. 0.46
- Max. score:
- 5
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 0.46
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- ca. 0.46
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
Any other information on results incl. tables
The more detailed information about results are not available.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
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