Registration Dossier
Registration Dossier
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EC number: 279-420-3 | CAS number: 80206-82-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: published data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Alcohol C14 Myristic. 1
- Author:
- Opdyke, D.L.J.
- Year:
- 1 975
- Bibliographic source:
- Fragrance raw material monographs 3(Suppl.) 699-700
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human maximisation procedure of Kligman 1966 and Kligman & Epstein, 1975.
- Principles of method if other than guideline:
- Human maximisation procedure of Kligman 1966 and Kligman & Epstein, 1975.
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetradecanol
- EC Number:
- 204-000-3
- EC Name:
- Tetradecanol
- Cas Number:
- 112-72-1
- Molecular formula:
- C14H30O
- IUPAC Name:
- tetradecan-1-ol
- Details on test material:
- - Analytical purity: not given
EC# : 204-000-3
CAS# : 112-72-1
Substance Name : tetradecanol
Molecular Formula : C14H30O
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed: 25
- Route of administration:
- dermal
- Details on study design:
- Tetradecanol at a concentration of 12% in petrolatum was tested in two series of 25 human volunteers using the human maximisation procedure of Kligman 1966 and Kligman & Epstein, 1975.
Results and discussion
- Results of examinations:
- In the first panel sensitisation reactions were reported in 2/25 volunteers. No sensitisation reactions were observed in the second test panel. Overall it appears that tetradecanol is not a skin senisiter in man.
Applicant's summary and conclusion
- Conclusions:
- In the first panel sensitisation reactions were reported in 2/25 volunteers. No sensitisation reactions were observed in the second test panel. Overall it appears that tetradecanol is not a skin senisiter in man.Tetradecanol is closely related to the registered substance, Alcohols, C16-18, and it is considered that read-across is valid.
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