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Toxicological information

Skin sensitisation

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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.