Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

Currently viewing:

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