Oleic acid, monoester with oxybis(propanediol)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vitro

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

28 Oct 2011 - 11 Jan 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Principles of method if other than guideline:

The Direct Peptide Reactivity Assay (DPRA) is an in vitro alternative method currently under evaluation of ECVAM and based on the publications of Gerberick et al. (2004 and 2007), Bauch et al. (2010) and Maxwell et al. (2011). The principle of this method is to determine the reactivity of a test substance towards synthetic cysteine (C)- or lysine (K)-containing peptides in order to assess its skin sensitisation potential. For this purpose, the test substance is incubated with synthetic peptides for approximately 24 h at room temperature and the remaining concentration of non-depleted peptides is analysed by high performance liquid chromatography with gradient elution and UV detection at 220 nm.

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany

Type of study:

other: Direct peptide reactivity assay (DPRA)

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C14-18 mono- and di-

EC Number:

266-952-6

EC Name:

Glycerides, C14-18 mono- and di-

Cas Number:

67701-33-1

IUPAC Name:

67701-33-1

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Chemical class: monodiglyceride
- Analytical purity: no data

In vivo test system

Test animals

Species:

other: not applicable

Strain:

other: not applicable

Results and discussion

Any other information on results incl. tables

  Table 1. REACTION WITH CYSTEIN-CONTAINING PEPTIDE

Reaction with cysteine-peptide	Peak area [mAU*s]			Peptide concentration [mM]
	Sample 1	Sample 2	Sample 3	Sample 1	Sample 2	Sample 3	Mean value	SD
NC 1: acetone	728.2	704.1	673.0	0.474	0.459	0.438	0.457	0.02
Test substance	679.1	718.7	703.8	0.442	0.468	0.458	0.456	0.01
NC 2: acetonitrile	707.2	695.5	675.5	0.461	0.453	0.440	0.451	0.01
PC: p-benzoquinone*	11.4	11.8	17.8	0.007	0.007	0.011	0.008	0.00

 

Reaction with cysteine-peptide	Peptide depletion [%]
	Sample 1	Sample 2	Sample 3	Mean value	SD
NC 1: acetone	-3.8	-0.3	4.1	0.0	3.9
Test substance	3.2	-2.4	-0.3	0.2	2.9
NC 2: acetonitrile	-2.1	-0.4	2.5	0.0	2.3
PC: p-benzoquinone*	98.5	98.4	97.5	98.1	0.5

NC: Negative control

PC: Positive control

*The calculation of peptide depletion of the PC was made relative to NC 2 as the PC was solved in acetonitrile.

 

Table 2. REACTION WITH LYSINE-CONTAINING PEPTIDE

Reaction with lysine-peptide	Peak area [mAU*s]			Peptide concentration [mM]
	Sample 1	Sample 2	Sample 3	Sample 1	Sample 2	Sample 3	Mean value	SD
NC 1: acetone	575.2	635.5	588.3	0.448	0.495	0.458	0.467	0.02
Test substance	593.6	625.8	598.6	0.462	0.487	0.466	0.472	0.01
NC 2: acetonitrile	** 648.4	645.1 643.6	645.2 644.1	- 0.505	0.502 0.501	0.502 0.502	0.503	0.00
PC: p-benzoquinone*	0.0	0.0	0.0	0.000	0.000	0.000	0.000	0.00

 

Reaction with lysine-peptide	Peptide depletion [%]
	Sample 1	Sample 2	Sample 3	Mean value	SD
NC 1: acetone	4.1	-6.0	1.9	0.0	5.3
Test substance	1.0	-4.4	0.2	-1.1	2.9
NC 2: acetonitrile	- -0.5	0.0 0.3	0.0 0.2	0.0	0.3
PC: p-benzoquinone*	100	100	100	100	0.0

NC: Negative control

PC: Positive control

*The calculation of peptide depletion of the PC was made relative to NC 2 as the PC was solved in acetonitrile.

**The value is considered to be a measurement error and thus not used for calculations. Hence, two measurements were performed for each of the 3 NC-samples. The remaining 5 values were used for calculations.

 

Table 3. MEAN PEPTIDE DEPLETION

	Cysteine-containing peptide		Lysine-containing peptide		Mean of both depletions[%]
	Mean depletion [%]	SD	Mean depletion [%]	SD
PC: p-benzoquinone*	98.1	0.5	100	0.0	99.1
Test substance	0.2	2.9	-1.1	2.9	0.1

Based on the observed results and applying the prediction model according to Gerberick et al. (2007), it was concluded that the test substance showed a minimal chemical reactivity in the DPRA under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material showed a minimal chemical reactivity in the DPRA. The results of this in vitro test are, however, not sufficient for the purpose of classification and labelling according to CLP and DSD.