Registration Dossier
Registration Dossier
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EC number: 200-267-5 | CAS number: 56-34-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses
- Author:
- European Commission
- Year:
- 2 007
- Bibliographic source:
- Opinion on alkyl (C16, C18, C22) trimethylammonium chloride, non-preservative uses, SCCP,2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Skin sensitization study of Cetrimonium chloride was performed in guinea pig by using Buehler test
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19-H42-N.Cl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Cetrimonium chloride - Molecular formula : C6H15N- Molecular weight : 101.191g/mole- Substance type: organic - Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Cetrimonium chloride
- Molecular formula : C6H15N
- Molecular weight : 101.191g/mole
- Substance type: organic
- Physical state: solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright albino
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 4%
- Day(s)/duration:
- 6hr
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1%
- Day(s)/duration:
- 6hr
- No. of animals per dose:
- Total :46
Preliminary study: 6 animals
Main study
Treated group:30
Control group:10 - Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: 6hr
- Test groups:30
- Control group:10
- Site: 2 x 2 cm cellulose patch to the clipped skin of the left flank.
- Frequency of applications: on day 1,8 and 15
- Duration: 15 days
- Concentrations: 4%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on day 29
- Exposure period:6hr
- Test groups:30
- Control group:10
- Site: 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing
- Concentrations:1%
- Evaluation (hr after challenge): 24 and 48hr
OTHER: All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31. - Challenge controls:
- yes
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 30
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Sensitizing
- Conclusions:
- The Cetrimonium chloride (112-02-7) was considered to be not skin sensitizing in guinea pig.
- Executive summary:
The skin sensitization study of Cetrimonium chloride(112-02-7) was performed byBuehler test using 30 female Pirbright albino guinea pigs in treated group and 10 in control group. Doses were selected on the bases of preliminary study using 6 animals.
In induction phase, induction given on day 1, using 4 % concentration in waterby topical application as2 x 2 cm cellulose patch to the clipped skin of the left flank. The patch was covered with an occlusive dressing for 6 hours and removed afterwards. The second induction given on day 8 and third on day 15 using same procedure on day first. During the induction phase, the skin sites were
examined for local effects 24 hours after each treatment
In challenge phase, on day 29 test substance 1% concentration in same vehicle appliedon a 2 x 2 cm patch to the clipped skin of the right flank and covered with an occlusive dressing for 6 hour and evaluated 24 and 48hr after removal of occlusive dressing .All animals were observed daily for signs of systemic toxicity. Body weights were recorded on days 1 and 31.No skin sensitizing reaction observed after challenge applicationals no clinical effects were observed. Body weight development of the treated group was not different from that of the control group. During the induction phase, treated animals showed slight to well-defined erythema and very slight oedema at the treated skin area. After challenge, skin reactions were observed neither in the treated group nor in the control group.Hence theCetrimonium chloride(112-02-7)was considered to be not skin sensitizing in guinea pig.
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