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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:
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:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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)

Results
Group:
test group
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
other: Group: test group. No with. + reactions: 4.0. Total no. in groups: 10.0.

Any other information on results incl. tables

TNG as a 7.5% solution in 25% peanut oil containig 67.5% 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.