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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Adverse skin reactions
Author:
A. J. Bircher
Year:
1991
Bibliographic source:
Contact Dermatitis, , 1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : Nicotine sulphate
- IUPAC name : 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid
- Molecular formula : C10H16N2O4S
- Molecular weight : 422.547 g/mol
- Smiles notation : CN1CCC[C@H]1c2cccnc2.CN 3CCC[C@H]3c4cccnc4.OS(=O)(=O)O
- InChl : 1S/2C10H14N2.H2O4S/c2* 1-12-7-3-5-10(12)9-4-2-6-11-8-9;1-5(2,3)4/h2*2,4,6,8,10H,3 ,5,7H2,1H3;(H2,1,2,3,4)/t2*10-;/m00./s1
- Substance type : Organic
- Physical state : Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Department of Dermatology, University of Basel, Switzerland
- Age at study initiation: mean age – 38.6 years (range 23 – 65 years)

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% aqueous solution
Day(s)/duration:
no data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5% aqueous solution
Day(s)/duration:
no data available
Adequacy of challenge:
not specified
No. of animals per dose:
10 male and 4 female
Details on study design:
Other: Patch tests were carried out with European Standard series except for primin(TRUE TEST) with aqueous nicotine sulphate 5% were tested. The patches were applied to the backs of subjects and were read at 2 and 3 days according to the recommendations of the ICDRG.
Positive patch test reactions were further assessed as irritant or allergic.
Challenge controls:
no data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
5% aqueous solution
No. with + reactions:
1
Total no. in group:
14
Clinical observations:
Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.Hence,the test chemical can be considered to be not sensitizing to skin.
Executive summary:

Patch tests were performed with aqueous solution of test chemical to determine the degree of allergenic reactions.

Patch tests were carried out with European Standard series except for primin(TRUE TEST) with 5% aqueous test chemical were tested. The patches were applied to the backs of 14 volunteers (10male and 5 female) and were read at 2 and 3 days according to the recommendations of the ICDRG.

Positive patch test reactions were further assessed as irritant or allergic.

Positive reactions were observed in only 1 volunteer.The test chemical was considered to be an insensitive test agent, mostly due to its poor solubility.

Hence, the test chemical can be considered to be not sensitizing to skin.