Tetrabutylammonium bromide

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 from publication and secondary source

Data source

Reference

Reference 1

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

Reference 2

Reference Type:

publication

Title:

Safety assessment of test chemical

Author:

Becker LC et al.,

Year:

2012

Bibliographic source:

Int J Toxicol; 2012

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 test chemical 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

Test material information

Constituent 1

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

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

Adequacy of challenge:

not specified

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, concurrent vehicle used

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Results 1

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

Results 2

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 test chemical was considered to be not skin sensitizing to the guinea pigs’ skin.

Executive summary:

The skin sensitization study oftest chemicalwas performed byBuehler test using30 femalePirbrightalbinoguinea 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 inwaterby 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 applicationalso 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 the test chemicalwas considered to be not skin sensitizing in guinea pig.