Registration Dossier
Registration Dossier
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EC number: 204-526-3 | CAS number: 122-18-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- Contact dermatitis to lauryl pyridinium chloride and benzoxonium chloride
- Author:
- DERK P. BRUYNZEEL, ANTON C. DE GROOT AND J. WILLEM WEYLAND
- Year:
- 1 987
- Bibliographic source:
- Contact Dermatitis 1987• 17: 41-60
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch tests with the European standard series (ICDRG)
- Principles of method if other than guideline:
- Patch test were performed to determine the irritation and allergenic potential of the test chemical
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cetalkonium chloride
- EC Number:
- 204-526-3
- EC Name:
- Cetalkonium chloride
- Cas Number:
- 122-18-9
- Molecular formula:
- C25H46ClN
- IUPAC Name:
- cetalkonium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material: Cetalkonium chloride
- IUPAC name: CETYL DIMETHYL BENZYL AMMONIUM CHLORIDE
- Molecular formula: C25H46ClN
- Molecular weight: 396.098 g/mole
- Smiles : c1(C[N+](CCCCCCCCCCCCCCCC)(C)C)ccccc1.[ClH-]
- Inchl: 1S/C25H46N.ClH/c1-4-5-6-7-8-9-10-11-12-13-14-15-16-20-23-26(2,3)24-25-21-18-17-19-22-25;/h17-19,21-22H,4-16,20,23-24H2,1-3H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid (white)
- Purity: 99.7%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Cetalkonium chloride
- Molecular formula : C25H46ClN
- Molecular weight : 396.098 g/mole
- Substance type: Organic
- Physical state: solid
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- - Sex: Male
- Source: Department of Dermatology, Free University Academic Hospital, Netherlands
- Age at study initiation: 28-year-old
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact skin
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 0.1%
- Duration of treatment / exposure:
- 72 hours
- Observation period:
- 48 and 72 hours
- Number of animals:
- 1
- Details on study design:
- No data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Signs of irritation observed
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- 0.1% aqueous test chemical was irritating to human skin.
- Executive summary:
This study reports of case of allergic dermal reactions observed in humans after exposure to a hair conditioner.
A 28-year-old male had recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm, where his wife usually rested her head when sleeping. He had noted that the eruption always developed after his wife had used a hair conditioner.
Patch tests with the European standard sense (ICDRG) and the conditioner (tested undiluted) showed a positive reaction only to the conditioner. Later its ingredients and additional quaternary ammonium salts were also tested separately.
0.1% aqueous test chemical was irritating to human skin.
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