Nicotine sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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 journal

Data source

Reference

Reference Type:

publication

Title:

Adverse skin reactions to nicotine in a transdermal therapeutic system

Author:

A. J. Bircher et.al

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:

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical

GLP compliance:

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

Details on test material:

Name of the test chemical: Pyridine, 3-(1-methyl-2-pyrrolidinyl)-, (S)-, sulfate (2:1)
Molecular formula:
C10H14N2.1/2H2O4S
Molecular weight:
422.54
SMILES notation:
CN1CCCC1C2=CN=CC=C2.CN1CCCC1C2=CN=CC=C2.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

Test animals

Species:

other: Human

Strain:

other: Not applicable

Details on test animals or test system 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)

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

5%

Duration of treatment / exposure:

20 minutes

Observation period:

20 minutes

Number of animals:

14 patients (10 male and 4 female)

Details on study design:

TEST SITE
- Area of exposure: ventral forearm
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 20 minutes

SCORING SYSTEM:
- Method of calculation:The skin reactions were assessed 20min after application according to the following rating:
0 = No reaction
± = equivocal reaction
+ = erythema
++ = wheal
+++ = pseudopods
Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 20 minutes

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Equivocal reaction was observed in 1 out of 14 treated patients.Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

Equivocal reaction was observed in 1 out of 14 treated patients.Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.

Executive summary:

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical. The test chemical was applied on the skin of ventral forearm of each subject at concentration of 5%. The skin reactions were assessed 20min after application from 0 to +++. Rating of equal or greater than + were quantified as contact urticarial reaction. In addition, subjective symptoms such as burning or itching were recorded. Equivocal reaction was observed in 1 out of 14 treated patients.Since the skin lesions were not observed in most of the treated patients the test chemical was considered to be not irritating to the skin of each subjects.