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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1974

Materials and methods

Principles of method if other than guideline:
To assess the skin sensitizing potential of phenethyl isovalerate by Kligman human maximization assay
GLP compliance:
not specified
Type of study:
other: Maximization test

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenethyl isovalerate
EC Number:
205-406-3
EC Name:
Phenethyl isovalerate
Cas Number:
140-26-1
Molecular formula:
C13H18O2
IUPAC Name:
phenethyl isovalerate
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report):Phenethyl isovalerate- Molecular formula (if other than submission substance):C13H1802- Molecular weight (if other than submission substance): 206.28 g/mol- Substance type:Organic- Physical state:Liquid- Analytical purity: No data available.

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
petrolatum
Concentration / amount:
2%
Challenge
Concentration / amount:
2%
No. of animals per dose:
26 human volunteers

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: not specified
Dose level:
2% in petrolatum
No. with + reactions:
0
Total no. in group:
26
Clinical observations:
No positive reaction observed
Remarks on result:
other: Reading: other: not specified. Dose level: 2% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 26.0. Clinical observations: No positive reaction observed.

Any other information on results incl. tables

not specified

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
A maximization test was carried out on 26 volunteers. The test chemical was tested at a concentration of 2% in petrolatum and produced no sensitization reactions.
Executive summary:

In skin sensitization study , maximization test was carried out on 26 volunteers. The test chemical was tested at a concentration of 2% in petrolatum and produced no sensitization reactions. Based on the above value ,the test material does not classify as an skin sensitizer.