Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Antimicrobials: Experimental contact sensitization in man
Author:
F. N. MARZULLI and H. I. MAIBACH
Year:
1973
Bibliographic source:
J. Soc. Cosmet Chem, 24, 399-421(1973)
Reference Type:
other: Authoritative database
Title:
Skin sensitization study of test chemical
Author:
HSDB
Year:
2018
Bibliographic source:
U.S. National Library of Medicine National Institutes of Health, Health & Human Services; 2018
Reference Type:
other: Secondary source
Title:
Contact sensitization study of test material.
Author:
Scientific Committee on Consumer Products
Year:
2005
Bibliographic source:
COLIPA n° P29, 2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize test
Principles of method if other than guideline:
Draize test was performed to evaluate the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
Draize test
Justification for non-LLNA method:
The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material: Triclocarban
- Molecular formula: C13H9Cl3N2O
- Molecular weight: 315.5861 g/mol
- Smiles notation: c1cc(ccc1NC(=O)Nc2ccc(c(c2)Cl)Cl)Cl
- InChl: 1S/C13H9Cl3N2O/c14-8-1-3-9(4-2-8)17-13(19)18-10-5-6-11(15)12(16)7-10/h1-7H,(H2,17,18,19)
- Substance type: Organic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: Human
Strain:
other: Not applicable
Sex:
male
Details on test animals and environmental conditions:
- Age at study initiation: 21-50 years, The test subjects were approximately 82%Caucasian, 13% Negro and 5% American Indian (Mexican). This test, like other predictive sensitization tests, is derived from Jadassohn's diagnostic patch test introduced around the turn of the century.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: aqueous soap suspension
Concentration / amount:
0.5 g of 1.5% test chemical in aqueous soap suspension
Day(s)/duration:
10 epicutaneous application; 48 or 72 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: aqueous soap suspension
Concentration / amount:
1.5% test chemical in aqueous soap suspension
Day(s)/duration:
72 hours
Adequacy of challenge:
not specified
No. of animals per dose:
200 male volunteers
Details on study design:
Details on study design
RANGE FINDING TESTS:no data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 48 to 72 hrs
- Test groups: 31
- Control group:no data
- Site: upper lateral portion of the arm
- Frequency of applications: 10 epicutaneous applications were administered successively to the same site for induction
- Duration: 48 to 72 hrs
- Concentrations:1. 5% test chemical in aqueous soap suspension

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 weeks of induction
- Exposure period: 72 hrs
- Test groups:31
- Control group: no data
- Site: upper lateral portion of the arm
- Concentrations: 5% test chemical in petrolatum
- Evaluation (hr after challenge): 72 hrs

OTHER: Skin reactions were assigned four grades of intensity: 1 = erythema; 2 = erythema snd
induration; 3 =vesiculation;and 4 =bulla formation.
Challenge controls:
not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
88
Clinical observations:
No evidence of skin sensitization in the 88 volunteers tested.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Response of human subjects tested with the test chemical in aqueous soap suspension (Draize procedure)

Induction

%

Challenge

%

Sensitized

Fraction

%

1.5

1.5

0/200

0

 

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical was not a contact sensitizer when 1.5% test chemical in aqueous soap suspension was used for induction. Hence, the test chemical was considered for not sensitizing to skin
Executive summary:

Draize test was performed to evaluate the dermal sensitization potential of the test chemical.

200 normal human volunteers aged between 21 -50 years were used for the study. 0.5 g of 1.5% test chemical was applied to the upper lateral portion of the arm, covered with an occlusive patch, and removed after 48 or 72 hours.10 epicutaneous applications were administered successively to the same site for induction. After a rest period of 2 weeks, the challenge patch was applied for 72 hours, the reactions were read. Skin reactions were assigned four grades of intensity: 1 = erythema; 2

= erythema snd induration; 3 =vesiculation;and 4 =bulla formation.

The test chemical was not a contact sensitizer when 1.5% test chemical in aqueous soap suspension was used for induction. Hence, the test chemical was considered for not sensitizing to skin