Registration Dossier
Registration Dossier
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EC number: 240-457-5 | CAS number: 16409-43-1
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature, peer-reviewed
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Repeated insult patch test of tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran in human subjects
- Author:
- IFF Incorporated
- Year:
- 1 964
- Bibliographic source:
- Cited in: Anonymous (1964); Fragrance raw materials monographs, Food. Chem. Toxicol. 30, Suppl. Issue VIII, 1992, p. 121S-122S; Cited in: RIFM Database, Location 14574
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Repeated Insult Patch Test conducted with volunteers
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- EC Number:
- 240-457-5
- EC Name:
- Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- Cas Number:
- 16409-43-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- Details on test material:
- no furter data available
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 40
- Sex: 31 females and 9 males - Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: no data
- Description of patch: Webril swatch affixed to adhesive elastic bandage
- Vehicle / solvent: 65% Ethanol
- Concentrations: 1.25%
- Volume applied: 0.5 mL
- Removal of test substance: after 24 hours
- Other: The patch was placed on the upper arm of each subject, and was removed after 24 hours. The induction patches were applied to the same site every Monday, Wednesday and Friday until 9 applications of the test material had been made. Reactions were read 24 hours after patch removal, or 48 hours when removed on Saturday. After a rest period of 14 days, challenge patches were applied to a previoulsy untreated test site in the same manner as during the induction phase, and the sites were scored 24 and 72 hours after patch removal.
Results and discussion
- Results of examinations:
- Little or no skin irritation was observed.
No skin sensitisation reactions were observed.
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.
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