Reaction product of Saccharose, Glycerine, biodiesel propoxylated

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

other: in chemico

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, in-house validated procedure

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Direct peptide binding assay (DPRA) performed as described in Bauch C. et al. (2011), Toxicology in Vitro 25, 1162 – 1168.

Principles of method if other than guideline:

Binding to Cysteine and Lysine containing model peptides in chemico

GLP compliance:

yes

Type of study:

other: Direct peptide binding assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of Saccharose, Glycerine, biodiesel propoxylated

EC Number:

940-005-3

Molecular formula:

Unspecified

IUPAC Name:

Reaction product of Saccharose, Glycerine, biodiesel propoxylated

Details on test material:

Test substance no.: 13/0453-1
Batch ID: T41/012/13
Purity: 100% UVCB substance
Homogeneity: The test substance was homogenous by visual inspection.
Molecular weight: The test substance is an UVCB substance unknown or variable composition, complex reaction products or biological materials. In agreement with the sponsor a molecular weight of 700 g/mol was used for calculation of the test substance preparation.

In vivo test system

Test animals

Species:

other: synthetic peptides (Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH; Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH)

Study design: in vivo (non-LLNA)

Induction

Vehicle:

other: acetonitrile

Challenge

Vehicle:

other: acetonitrile

Results and discussion

Positive control results:

EGDMA caused depletion of both peptides in all samples.

Any other information on results incl. tables

The test substance was soluble in acetonitrile. However, mixed with the peptide stock solutions, the samples were emulsions. Visual observation after the 24-hour incubation time revealed emulsions of all samples of test substance with both peptides, still. Thus the samples of both peptides and the co-elution controls were centrifuged prior to HPLC analysis. No co-elution of test substance and peptides was noticed.

The mean Cysteine-peptide depletion, caused by the test substance was determined to be 0.46 %. The mean Lysine-peptide depletion, caused by the test substance was determined to be -0.98 %. Negative depletions were considered to be “zero” for calculation of the mean peptide depletion, which was thus calculated to be 0.23 %. No co-elution of test substance and peptides was noticed. The positive control substance caused depletion of both peptides comparable to historical control data.

Applicant's summary and conclusion

Interpretation of results:

other: Minimal peptide binding

Conclusions:

Based on the observed results and applying the prediction model proposed in Gerberick et al. it was concluded that Reaction product of Saccharose, Glycerine, biodiesel propoxylated shows a minimal chemical reactivity in the DPRA under the test conditions chosen.