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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
publication
Title:
delta–dodecalactone.
Author:
D.L.J.Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology, Volume 17, Supplement, December 1979, Pages 773-774

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Maximization test
Principles of method if other than guideline:
A maximization test was performed to determine the sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
other: Maximization test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment.

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecan-5-olide
EC Number:
211-932-4
EC Name:
Dodecan-5-olide
Cas Number:
713-95-1
Molecular formula:
C12H22O2
IUPAC Name:
6-heptyloxan-2-one
Test material form:
liquid
Details on test material:
- Name of the test material : Dodecan 5- olide
- Molecular formula : C12H22O2
- Molecular weight : 198.31 g/mol
- Substance type : Organic
- Physical state : Liquid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
12% in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
12% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
30
Details on study design:
no data available
Challenge controls:
no data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
12% in petrolatum
No. with + reactions:
0
Total no. in group:
30
Clinical observations:
No dermal reactions observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.
Executive summary:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 12% in petrolatum was applied to the skin of 30 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 12% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.