Oct-1-ene-3-ol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in chemico

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Study carried out from 9 November 2015 to 26 November 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))

Deviations:

no

Principles of method if other than guideline:

The Direct Peptide Reactivity Assay (DPRA) is an in chemico test to determine the reactivity of test a substance towards peptides.
This assay has been validated for a broad range of low-molecular weight chemicals and it was found to detect reactive skin sensitizers from a broad range of so called applicability domains, i.e. chemicals reacting with proteins by different mechanisms. It was validated by ECVAM and proposed to be used as part of an integrated approach for testing and assessment (IATA).

GLP compliance:

yes

Type of study:

direct peptide reactivity assay (DPRA)

Test material

Test material information

Constituent 1

Reference substance name:

Oct-1-ene-3-ol

EC Number:

222-226-0

EC Name:

Oct-1-ene-3-ol

Cas Number:

3391-86-4

Molecular formula:

C8H16O

IUPAC Name:

oct-1-en-3-ol

Test material form:

liquid

Specific details on test material used for the study:

Lot No.: VE00345297
Physical form: Liquid
Purity: 99.8%

In chemico test system

Details on the study design:

The test substance AMYL VINYL CARBINOL was dissolved in acetonitrile and mixed with a Cysteine- and a Lysine-containing peptide according to the standard operating procedure of the DPRA. One study with three replicates was conducted. After 24 h incubation time, peptide depletion induced by AMYL VINYL CARBINOL was determined by HPLC-UV.

Results and discussion

Positive control results:

As indicated in Table 7, all the acceptance criteria were fulfilled for the positive control cinnamic aldehyde, with the exception of the CV for the Lys peptide which is at 12.4%, and thus slightly above the threshold of 11.6. However since this is so close to the threshold and the three individual depletion values (64.6, 50.9, 62.6) all nicely fall in the target range and the historical range (Table C1), this was considered an acceptable deviation.

In vitro / in chemico

Results

Results 1

Parameter:

other: Cys-peptide depletion

Value:

65.2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of skin sensitisation

Remarks:

Value is a percentage

Results 2

Parameter:

other: Lys-peptide depletion

Value:

1.2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of skin sensitisation

Remarks:

Value is a percentage

Other effects / acceptance of results:

The test substance gave 65.2 % depletion of the Cys-peptide and 6.7 % depletion of the Lys-peptide. The average peptide depletion is 36.0 %. This is below the threshold of 22.6%, and the substance is thus attributed to the “moderate” reactivity class, rating it as a sensitizer according to the DPRA prediction model.
Acceptance criteria: The standard deviation for Cys-peptide depletion should be < 14.9% and for Lys-peptide depletion < 11.6%. These criteria were fulfilled (4.7% and 0.3% SD, respectively).
The co-elution controls indicated no co-elution with an UV-absorbing component.

Any other information on results incl. tables

	Average	Standard deviation
Cys-peptide depletion	65.2	4.7
Lys-peptide depletion	6.7	0.3
Average depletion Cys-and Lys-peptide	36.0
Reactivity Class	MODERATE
Prediction	Sensitizer
Elution time Cys peptide	10.75
Elution time test substance Cys peptide run	No UV peak
Elution time Lys peptide	8.02
Elution time test substance Lys peptide run	No UV peak

Applicant's summary and conclusion

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

The result of the DPRA assay should be used as part of an integrated approach for testing and assessment (IATA). A parallel test in the KeratinoSens™ assay may indicate whether congruent results are obtained by both test methods. According to a detailed analysis on large set of chemicals, two congruent results in these two tests give a good prediction of the sensitizer hazard [3-5] particularly when predicting human data, while an additional test in a dendritic cell line assessing expression of surface markers may be needed in case of discordant results.
AMYL VINYL CARBINOL was peptide-reactive and classified into the moderate reactivity class according to the prediction model. It is therefore considered a sensitizer according to the prediction model of the DPRA.

Executive summary:

AMYL VINYL CARBINOL was peptide-reactive and classified into the moderate reactivity class according to the prediction model. It is therefore considered a sensitizer according to the prediction model of the DPRA.