Registration Dossier
Registration Dossier
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EC number: 204-116-4 | CAS number: 115-95-7
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative studies on the irritancy of oils and synthetic perfumes to the skin of rabbit, guinea pig, rat, miniature swine and man
- Author:
- Motoyoshi K, et al.
- Year:
- 1 979
- Bibliographic source:
- Cosmetics and Toiletries 94 (8), 41-48
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- Linalyl acetate
- EC Number:
- 204-116-4
- EC Name:
- Linalyl acetate
- Cas Number:
- 115-95-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-en-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): 3,7-dimethyl-1,6-octadien-3-yl-acetate (linalyl acetate),
- Analytical purity: >95%
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 50
- Sex: male - Clinical history:
- - History of allergy or casuistics for study subject or populations: none, these volunteers were excluded
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: 15 mm diameter
- Vehicle / solvent: acetone
- Concentrations: 32%
- Volume applied: 0.05 ml
EXAMINATIONS
Grading/Scoring system:
-: negative reading
+/-: questinoable erythema not covering the entire patch area
+: definite erythema of the entire patch area
++: erythema and edema
+++: erythema and edema and vesicles (or papules)
++++: Bullous reaction
Results and discussion
Any other information on results incl. tables
Linalyl acetate tested at 32% in acetone was found to be negative in the human patch test. Considering a circular patch with a 15 mm diameter, an area of approx. 2 cm2 has been exposed (area=pi*7.5^2). Application of 0.05 g test substance containing 32 % linalyl acetate would result in an applied dose of 8000 µg/cm2 (external load=32%*0.05g/2 cm2).
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.
