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Toxicological information

Skin sensitisation

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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:
2007
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:
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
Name:
Unnamed
Type:
Constituent
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
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 group
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 group
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.