Registration Dossier
Registration Dossier
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EC number: 222-182-2 | CAS number: 3380-34-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test material was not well characterized, however, the test conduct and the results are of scientific acceptability.
Data source
Reference
- Reference Type:
- publication
- Title:
- Low allergenicity of triclosan. Predictive testing in guinea pigs and in humans
- Author:
- Lachapelle JM, Tennstedt D
- Year:
- 1 979
- Bibliographic source:
- Dermatologica 158: 379-383
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test in human was conducted according to a modified Maximisation Test (Kligman and Epstein, Updating the maximization test for identifying contact allergens. Contact Dermatitis 1: 231-239, 1975).
- GLP compliance:
- no
- Remarks:
- ; not applicable
Test material
- 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
- Details on test material:
- - Name of test material (as cited in study report): Irgasan DP 300
- No further data given.
Constituent 1
Method
- Type of population:
- general
- Subjects:
- Twenty adult volunteers of both sexes per group.
- Controls:
- The 20 control subjects were patch tested with Triclosan 5%, 2% and 1% in petrolatum.
Tests were performed on the upper part of the back and were removed after 48 hours.
Two readings were made after 48 and 96 hours. An additional reading was made 7 days later. - Details on study design:
- PATCH TEST:
Preparation of the application site: 5% sodium lauryl sulphate under occlusion for 24 h.
Induction: Application of 20% triclosan in petrolatum at the same site on days 1,3, 5, 7, and 9.
After the last induction: Resting period of 14 days.
Challenge: 14 days after the last induction, using 1%,2%, or 5% triclosan; a control patch test with petrolatum also was performed.
Results and discussion
- Results of examinations:
- INDUCTION
During induction, 17 of the 20 tested subjects showed signs of skin irritation consisting of erythema and slight oedema, which were moderately painful.
CHALLENGE
None of the 20 test volunteers and none of the control volunteers showed positive patch test reactions up to 7 days post-challenge.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
