Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Fragrance contact dermatitis study in the test chemical
Author:
Susun An et al
Year:
2005
Bibliographic source:
Contact Dermatitis (2005)
Reference Type:
publication
Title:
Skin irritation assay of the test chemical
Author:
D. Belsito et.al
Year:
2011
Bibliographic source:
Food and Chemical Toxicology, 2011
Reference Type:
publication
Title:
Fragrance material review on test chemical
Author:
D. McGinty
Year:
2011
Bibliographic source:
Food and Chemical Toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Skin sensitization study was conducted to evaluate the toxic nature of the test compound.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxacycloheptadec-10-en-2-one
EC Number:
249-120-7
EC Name:
Oxacycloheptadec-10-en-2-one
Cas Number:
28645-51-4
Molecular formula:
C16H28O2
IUPAC Name:
oxacycloheptadec-10-en-2-one
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Ambrettolide
- Molecular formula : C16H28O2
- Molecular weight : 252.395 gram/mol
- Substance type: Organic
- Smiles : C1C=CCCCCCCOC(CCCCCC1)=O
- InChI : 1S/C16H28O2/c17-16-14-12-10-8-6-4-2-1-3-5-7-9-11-13-15-18-16/h1,3H,2,4-15H2/b3-1-
- Physical state: Liquid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ambrettolide
- Molecular formula : C16H28O2
- Molecular weight : 252.395 gram/mol
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
other: human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Patients with suspected contact dermatitis from 9 university hospitals in Korea
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From April 2002 to June 2003

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5%
Day(s)/duration:
no data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5%
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
422 Korean patients
Details on study design:
Finn Chambers on Scanpor fape (Epitest, Tuusula, Finland) tape was used for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.
- No. of exposures: No data available
- Exposure period: No data available
- Test groups: 422
- Control group: No data available
- Site: Most common site was the Face. Neck, trunk, eyelid, lips, hand, arm, leg, scalp, ear, foot and widespread areas were also evaluated.
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 5%


Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
422
Clinical observations:
Negative result were observed in 422 patients.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.
Executive summary:

A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.