Nicotine sulphate

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

Nicotine sulphate

EC Number:

200-606-7

EC Name:

Nicotine sulphate

Cas Number:

65-30-5

Molecular formula:

C10H14N2.1/2H2O4S

IUPAC Name:

3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid

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

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

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.