Registration Dossier
Registration Dossier
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EC number: 202-924-1 | CAS number: 101-20-2
Skin sensitisation
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:
- 1 973
- 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:
- 2 018
- 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:
- 2 005
- Bibliographic source:
- COLIPA n° P29, 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Triclocarban
- EC Number:
- 202-924-1
- EC Name:
- Triclocarban
- Cas Number:
- 101-20-2
- Molecular formula:
- C13H9Cl3N2O
- IUPAC Name:
- 1-(4-chlorophenyl)-3-(3,4-dichlorophenyl)urea
- 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
Constituent 1
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 chemical
- 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
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