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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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:
other: Data is from review article or handbook

Data source

Reference
Reference Type:
review article or handbook
Title:
OPINION ON Triclosan COLIPA n° P32
Author:
Scientific Committee on Consumer Products (SCCP)
Year:
2009
Bibliographic source:
European Commission Health & Consumer Protection DG Directorate-SCCP/1192/08-21 January 2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization test was conducted in guinea pigs for Triclosan according to Buehler test.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Not Specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Triclosan
EC Number:
222-182-2
EC Name:
Triclosan
Cas Number:
3380-34-5
Molecular formula:
C12H7Cl3O2
IUPAC Name:
5-chloro-2-(2,4-dichlorophenoxy)phenol
Test material form:
other: solid
Details on test material:
- Name of test material: Triclosan- Molecular formula: C12H7Cl3O2- Molecular weight: 289.5 g/mol- Substance type: organic - Physical state: solid -InChI: 1S/C12H7Cl3O2/c13-7-1-3-11(9(15)5-7)17-12-4-2-8(14)6-10(12)16/h1-6,16H-Smiles: c1(Oc2c(cc(Cl)cc2)Cl)c(cc(Cl)cc1)O

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1% triclosan in a cream/gel
Concentration / amount:
1% triclosan in a cream/gel
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 1% triclosan in a cream/gel
Concentration / amount:
1% triclosan in a cream/gel
No. of animals per dose:
115: test animals6: control animals
Details on study design:
MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 9- Exposure period: 5 hours- Test groups:5 animals- Control group:6 animals- Site: backs of animals- Frequency of applications: no data- Duration: no data- Concentrations: 1% triclosan in a cream/gelB. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: 14 to 21 days after induction.- Exposure period: no data- Test groups: 5 animals- Control group: 6 animals- Site: backs of animals- Concentrations: 1% triclosan in a cream/gel- Evaluation (hr after challenge): 24 and 48 hours after the challenge.
Challenge controls:
yes concurrent vehicle.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% triclosan in a cream/gel
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
slight irritation (redness) 24 hours after the challenge
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% triclosan in a cream/gel. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: slight irritation (redness) 24 hours after the challenge.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% triclosan in a cream/gel
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
slight irritation (redness) 48 hours after the challenge
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% triclosan in a cream/gel. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: slight irritation (redness) 48 hours after the challenge.

Any other information on results incl. tables

Induction: Slight primary irritation was observed after the first few treatments but was alleviated with regular wash-off procedures.

Challenge: Treated sites showed slight irritation (redness) 24 and 48 hours after the challenge. Previously untreated sites did not show any significant oedema or erythema after challenge.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material Triclosan (CAS No: 3380-34-5) was observed to be not sensitizing on guinea pig skin.
Executive summary:

The Guinea pig Buehler test was conducted in Hartley (albino) Guinea pigs to assess sensitization potential of test chemical Triclosan (CAS No: 3380-34-5).

 

The 1% triclosan in a cream/gel was applied dermally (occluded) on back of guinea pigs for both induction and challenge treatment. 5 test and 6 control animals were used. Test sample was applied for 5 hours exposure period during induction. 14 to 21 days after induction, challenge was performed and skin reactions were observed 24 and 48 hours after the challenge.

 

 Slight irritation was observed during the induction period on the test site. The study investigators concluded that no sensitisation was observed, as previously untreated sites did not show any significant oedema or redness following the challenge dose.

 

 Based upon the observations, it is concluded that the test chemical Triclosan (CAS No: 3380-34-5) is not sensitizing to guinea pigs.