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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:
δ-Decalactone
Author:
D. L. J. OPDYKE
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology, 739-740, 1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Maximization test
Principles of method if other than guideline:
A human maximization test was carried out to assess the dermal 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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of the test chemical: 6-pentyltetrahydro-2H-pyran-2-one
- Common name: delta-decalactone
- Molecular Formula: C10H18O2
- Molecular Weight: 170.252 g/mol
- Smiles:O1[C@@H](CCCC1=O)CCCCCInChI:1S/C10H18O2/c1-2-3-4-6-9-7-5-8-10(11)12-9/h9H,2-8H2,1H3
- Substance type: Organic
- Consistency: 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:
1% in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
25
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
1st reading
Group:
test group
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
The test chemical 1% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical 1% 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 1% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 1% 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.