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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Fragrance raw material monograph for the test chemical
Author:
D. L. J. Opdyke
Year:
1978
Bibliographic source:
Food and Cosmetics Toxicology,1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal sensitization potential of test chemical in humans.
GLP compliance:
not specified
Type of study:
other: Human Maximization test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Human Maximization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopentyl phenylacetate
EC Number:
203-012-6
EC Name:
Isopentyl phenylacetate
Cas Number:
102-19-2
Molecular formula:
C13H18O2
IUPAC Name:
isopentyl phenylacetate
Test material form:
not specified
Details on test material:
- Name of test material (IUPAC name): Isopentyl phenylacetate
- Common name: Isoamyl phenylacetate
- Molecular formula: C13H18O2
- Molecular weight: 206.283 g/mol
- Smiles notation: c1(CC(OCCC(C)C)=O)ccccc1
- InChl: 1S/C13H18O2/c1-11(2)8-9-15-13(14)10-12-6-4-3-5-7-12/h3-7,11H,8-10H2,1-2H3
- Substance type: Organic

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% in petrolatum
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
29 human volunteers
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2% in petrolatum
No. with + reactions:
0
Total no. in group:
29
Clinical observations:
no 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 did not cause any dermal reactions and no dermal sensitizing effects were observed.Hence, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical.The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.