Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-892-8 | CAS number: 706-14-9
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1975
- Rationale for reliability incl. deficiencies:
- other: No data on ethical approval. Only 25 volunteers were tested, the concentration of the substance applied was not reported, no data on rest period
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Maximisation test in humans
- GLP compliance:
- no
Test material
- Reference substance name:
- Decan-4-olide
- EC Number:
- 211-892-8
- EC Name:
- Decan-4-olide
- Cas Number:
- 706-14-9
- Molecular formula:
- C10H18O2
- IUPAC Name:
- 5-hexyloxolan-2-one
- Reference substance name:
- 5-hexyldihydrofuran-2(3H) -one
- IUPAC Name:
- 5-hexyldihydrofuran-2(3H) -one
- Details on test material:
- - Name of test material (as cited in study report): #74-10-182 gamma-decalactone
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: RIFM #74-10-182
- Expiration date of the lot/batch: no data
- Reception date: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Sex: 9 males and 16 female
- Age: 18-35 years
- Race: 16 whites, 9 blacks
- Demographic information: no data - Clinical history:
- Heathly volunteer
- Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- - Number of subjects exposed: 25
- Sex: 9 males and 16 female
- Age: 18-35 years
- Race: 16 whites, 9 blacks
- Demographic information: no data
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: none
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Under the conditions employed in this study, there was no evidence of sensitisation to γ-Decalactone.
- Executive summary:
A panel of 25 male and female human healthy adult volunteers participated in a maximization test in which γ-Decalactone was applied to the volar forearm of the subjects under occlusive patches. During the induction phase patch were applied for five alternate-day 48 hour periods. The patches were removed 24 hours after application. As γ-Decalactone was not irritating in the pre-test, the patch site was pre-treated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours thereafter.
Under the conditions employed in this study, there was no evidence of sensitisation to γ-Decalactone.
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.
