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Toxicological information

Skin irritation / corrosion

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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:
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 Nicotine sulphate (CAS No: 65-30-5).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- IUPAC Name: 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid
- Common Name: Nicotine sulphate
- InChI: 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
- Smiles: CN1CCC[C@H]1c2cccnc2.CN3CCC [C@H]3c4cccnc4.OS(=O)(=O)O
- Molecular formula :C10H16N2O4S
- Molecular weight :422.547 g/mol
- Substance type:Organic
- Physical state:Solid
Specific details on test material used for the study:
- IUPAC Name: 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid
- Common Name: Nicotine sulphate
- InChI: 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
- Smiles: CN1CCC[C@H]1c2cccnc2.CN3CCC [C@H]3c4cccnc4.OS(=O)(=O)O
- Molecular formula:C10H16N2O4S
- Molecular weight :422.547 g/mol
- Substance type:Organic
- Physical state:Solid, white brown crystalline

Test animals

Species:
other: Human
Strain:
other: Not applicable
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)

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

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.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test chemical Nicotine sulphate (CAS No: 65-30-5) was considered to be not irritating to the skin of treated patients.
Executive summary:

The skin irritation study was conducted on 14 patients to determine the degree of contact irritation caused by the test chemical Nicotine sulphate (CAS No: 65-30-5).

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 Nicotine sulphate (CAS No: 65-30-5) was considered to be not irritating to the skin of each subjects.