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EC number: 200-606-7 | CAS number: 65-30-5
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:
- 1 991
- 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
- 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
Constituent 1
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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