Registration Dossier
Registration Dossier
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EC number: 225-896-2 | CAS number: 5137-55-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from NTRL reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- INITIAL SUBMISSION: RELATIVE TOXICITY OF CANDIDATE MOTHPROOFING UNIFORM IMPREGNANT with cover letter
- Author:
- NTRL report
- Year:
- 1 969
- Bibliographic source:
- NTRL report, 1969
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Prophetic patch test were conducted to determine the allergenic potential of the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Methyltrioctylammonium chloride
- EC Number:
- 225-896-2
- EC Name:
- Methyltrioctylammonium chloride
- Cas Number:
- 5137-55-3
- Molecular formula:
- C25H54ClN
- IUPAC Name:
- methyltrioctylammonium chloride
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): METHYLTRICAPRYLYL AMMONIUM CHLORIDE
- Common name: Aliquat 336
- Molecular formula : C25H54ClN
- Molecular weight : 404.162 g/mol
- Substance type: organic
- Physical state: pale yellow viscous liquid
Constituent 1
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5% w/w
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5% w/w concentration
- Day(s)/duration:
- 24
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 31
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single exposure
- Exposure period: 48 hours
- Test groups:1
- Control group: no data available
- Site: the intact skin of left arm of 31 human volunteers
- Frequency of applications: single
- Duration: 48 hours
- Concentrations: 0.5% (w/w) concentration
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 2 days
- Test groups:1
- Control group: no data available
- Site: the intact skin of left arm of 31 human volunteers
- Concentrations: 0.5% (w/w) concentration
- Evaluation (hr after challenge): 24 hours - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%w/w
- No. with + reactions:
- 0
- Total no. in group:
- 31
- Clinical observations:
- no evidence of irritation or sensitization
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- A prophetic patch test on humans of wool fabric impregnated with the 0.5%(w/w) of the test chemical, produced no evidence of irritation or sensitization.
Hence, Methyl(trioctyl)azanium chloride can be considered to be not sensitizing to human skin. - Executive summary:
Prophetic patch tests were conducted to determine the allergenic potential of the test chemical. Methyl(trioctyl)azanium chloride impregnated in wool fabric(1 inch square) a 0.5% (w/w) concentration and untreated wool fabric (1 inch square) was applied to the intact skin of left arm of 31 human volunteers for 48 hours.
After 2 weeks of rest period, the humans were sensitized with the same dose to approximately same area of the skin for 48 hours.
A prophetic patch test on humans of wool fabric impregnated with the 0.5%(w/w) of the test chemical, produced no evidence of irritation or sensitization.
Hence, Methyl(trioctyl)azanium chloride can be considered to be not sensitizing to human skin.
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