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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
22.Sept.2010 - 5.Nov.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test according to standard method and GCP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
GLP compliance:
yes
Remarks:
Good clinical practice

Test material

Constituent 1
Chemical structure
Reference substance name:
(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
EC Number:
208-205-9
EC Name:
(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
Cas Number:
515-69-5
Molecular formula:
C15H26O
IUPAC Name:
6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol
Details on test material:
Bisabolol preparation

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 112 (107 subjects completed the study); 5 discontinued unrelated to test material application.
- Sex: male and female
- Age: 18 to 79 years
Clinical history:
no data
Controls:
no
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Repeated insult patch test

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: DEP/EtOH (3:1)
- Concentrations: 10% or 5600 µg/cm2 (estimated: 3/4``x 3/4`` = 3.6 cm2 -> 0.2 ml incl. 10% TS = ca. 20 mg)
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction: 9 applications (3 per week) for 24 hours
Challenge: 1 application 2 weeks after final induction patch for 24 hours
Scoring: 24h, 72h post-application

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/107
- Number of subjects with negative reactions 107/107

Induction phase:
1 subject showed a transient barely perceptible erythema on induction 4-7
1 subject showed a transient barely perceptible erythema on induction 5

Any other information on results incl. tables

The test material (10%; 5600 µg/cm2 (estimated)) did not indicate a potential for dermal irritation or allergic contact sensitization.

Applicant's summary and conclusion