Registration Dossier

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:
1979
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Irgasan DP 300
- No further data given.

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