Registration Dossier
Registration Dossier
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EC number: 230-597-5 | CAS number: 7212-44-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data available as short summary from a secondary source beeing cited in a peer-reviewed publication
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Report on humman maximization studies
- Author:
- Kligman AM
- Year:
- 1 973
- Bibliographic source:
- Report to RIFM (Location 1802, Sub-Reference 07/27); cited in: Opdyke DLJ (1975): Monographs on Fragrance Raw Materials. Food Cosmet Toxicol 13: 887
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Kligman maximization test; no further data given
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers
- EC Number:
- 230-597-5
- EC Name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers
- Cas Number:
- 7212-44-4
- Molecular formula:
- C15H26O
- IUPAC Name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Nerolidol, isomer unspecified
- Analytical purity: no data given
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Sex: male
- Other: test was conducted on inmates - Controls:
- no data given
- Route of administration:
- dermal
- Details on study design:
- A 48-h patch test was conducted on the backs of 25 healthy volunteers.
The vehicle was petrolatum.
Although not specified in this reference, 1 ml of test substance formulation (incl 4% Nerolidol) was generally applied on a skin area of 14.5 cm2* (-> 2760 µg Nerolidol/cm2).
*Kligman 1966; The identification of contact allergens by human assay. - III. The maximization test: A procedure for screening and rating contact sensitizers. Journal of Investigative Dermatology Vol 47(5); pp. 393-409.
Results and discussion
- Results of examinations:
- At a concentration of 4 % (2760 µg/cm2) no effects were seen.
Applicant's summary and conclusion
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