Registration Dossier
Registration Dossier
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EC number: 815-521-6 | CAS number: 72691-24-8
Sensitisation data (human)
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:
- 2 010
- 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
- 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
Constituent 1
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
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.
