Registration Dossier
Registration Dossier
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EC number: 204-526-3 | CAS number: 122-18-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 test
- 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
- Type of study:
- patch test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
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: Cetalkonium chloride
- IUPAC name: CETYL DIMETHYL BENZYL AMMONIUM CHLORIDE
- Molecular formula: C25H46ClN
- Molecular weight: 396.098 g/mole
- Smiles Notation: 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 crystalline powder (white)
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: Department of Dermatology, Free University Academic Hospital, Netherlands
- Age at study initiation: 28-year-old
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1% aqueous
- Day(s)/duration:
- 72 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- 0.1% aqueous the test chemical was not sensitizing to human skin.
Hence, the test chemical can be considered to be not sensitizing to skin. - Executive summary:
Patch tests were performed to determine the irritation and allergenic potential of the test chemical.
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 the test chemical was not sensitizing to human skin.
Hence, the test chemical can be considered to be not sensitizing to skin.
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