Registration Dossier
Registration Dossier
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EC number: 203-232-2 | CAS number: 104-74-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- 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 vol. 17 pages- 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 was conducted to study skin sensitization of chemical.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Study was based on the effects observed in human volunteer after exposure of the substance.
Test material
- Reference substance name:
- 1-dodecylpyridinium chloride
- EC Number:
- 203-232-2
- EC Name:
- 1-dodecylpyridinium chloride
- Cas Number:
- 104-74-5
- Molecular formula:
- C17H30N.Cl
- IUPAC Name:
- 1-dodecylpyridin-1-ium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Laurylpyridinium chloride (1-dodecylpyridinium chloride)
- Molecular formula : C17H30NCl
- Molecular weight: 283.884 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: No data
- Impurities (identity and concentrations): No data
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: not applicable
- Sex:
- male
- Details on test animals and environmental conditions:
- Details on test animal
TEST ANIMALS
- Age at study initiation:28 year old
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1 %, .01%
- Day(s)/duration:
- no data
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 23
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Single
- Exposure period: 48 and 72-hrs
- Test groups: Yes
- Control group: 23 controls were tested
- Site: the left side of the chest and adjacent area of the arm
- Frequency of applications: No data
- Duration: No data
- Concentrations: 0.01 and 0.1%
B. CHALLENGE EXPOSURE: no data - Challenge controls:
- Yes,
23 controls were tested - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Positive reacrtion were observed
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: Control group
- Dose level:
- 0.1 %
- Total no. in group:
- 23
- Clinical observations:
- Stong positive reaction were observed
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Of 23 controls tested with 0.1% aq test chemical ., 16 were negative, 6 had a ? +, and 1 a + reaction.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- 0.1% aqueous test chemical was sensitizing to human skin.
Hence, the test chemical can be considered to be 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.
Of 23 controls tested with 0.1% aq test chemical, 16 were negative, 6 had a ? +, and 1 a + reaction.
0.1% aqueous test chemical was sensitizing to human skin.
Hence, the test chemical can be considered to be sensitizing to skin.
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