Registration Dossier
Registration Dossier
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EC number: 200-240-8 | CAS number: 55-63-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 generally accepted scientific standards, well documented and acceptable for assessment.
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: Magnusson, B. and A.M. Kligman (1969). The identification of contact allergens by animal assay. The guinea pig maximization test. J. Invest. Derm. 52. 268 – 276.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- already available studies
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Sma´l Stoc Industries (Pea Ridge, Arkansas)- Housing: plastic cages with hardwood bedding- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- other: peanut oil
- Concentration / amount:
- 3.41% TNG
Challengeopen allclose all
- Vehicle:
- other: peanut oil
- Concentration / amount:
- 3.41% TNG
- No. of animals per dose:
- 10 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 65% peanut oil/ 35% lactose
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 65% peanut oil/ 35% lactose
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3.41% in lactose/peanut oil
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- “moderate” skin sensitization was observed
Any other information on results incl. tables
TNG as a 3,41% solution in 31,5% peanut oil containig 65% lactose produced 40% response according to the guinea pig "maximization test" procedure. The more detailed information about resulst are not available.
Applicant's summary and conclusion
- Interpretation of results:
- ambiguous
- Remarks:
- Migrated information
- Conclusions:
- Nitroglycerin caused "moderate" skin sensitization in this test and is likely to cause skin sensitization in a small fraction of humans following repeated skin contact.
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