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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.