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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
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

Constituent 1
Chemical structure
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.

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