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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1946-1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Note that it is unlikely that the laboratory was operating according to all GLP principles at the time of the testing but this is unlikely to have influence study reliability.

Data source

Reference
Reference Type:
publication
Title:
Occupational allergic contact dermatitis caused by nitroglycerin
Author:
Kanerva, L., Laine, R., Jolanski, R., Tarvainen, K., Estlander, T. and Helander, I.
Year:
1991
Bibliographic source:
Contact Dermatitis, 24, 356-362

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
This study (Kanerva et al. 1991) and similar studies (e.g. Sausker & Frederick 1978) were performed using NG alone and testing its formulating ingredient separately given that questions were raised regarding the formulating ingredient being the true cause of skin sensitization in occupational settings. The incidence of sensitization at the Institute of Dermatology, Institute of Occupational Health, Helsinki (that of the Kanerva study authors) was 4/6151 or 0.07%.

Dermal application for 24 hours or 48 hours using Finn Chambers for 3 human subjects. EGDN at concentrations of 0.01 to 2% aq. 2% ammonium nitrate in petrolatum was applied to pricked skin in one female and three male human subjects.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
The studies were performed between 1946 - 1988 when the patch test was an accepted method to assess skin sensitiziation potential.

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene dinitrate
EC Number:
211-063-0
EC Name:
Ethylene dinitrate
Cas Number:
628-96-6
Molecular formula:
C2H4N2O6
IUPAC Name:
ethane-1,2-diyl dinitrate

In vivo test system

Test animals

Species:
other: human
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, and 2% aq. 2% ammonium nitrate in petrolatum
Challenge
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, and 2% aq. 2% ammonium nitrate in petrolatum
No. of animals per dose:
Each patient (n=3) was administered each dose
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
3
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 2%. No with. + reactions: 0.0. Total no. in groups: 3.0.
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Low to moderate skin sensitization may be observed in some patients based upon the concentrations tested. However, the likelihood of occurrence among the exposed population appears to be low.

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