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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
Study period:
2014
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 (incl. certificate)
Type of study:
other: Direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

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

Results and discussion

Positive control results:
All peptide was depleted by the positive control substance p-benzoquinone.

Any other information on results incl. tables

The mean Cysteine-peptide depletion, caused by the test substance was determined to be -0.33 %.

The mean Lysine-peptide depletion, caused by the test substance was determined to be -0.90%.

Negative depletions were considered to be “zero” for calculation of the mean peptide depletion, which was thus calculated to be 0%.

No co-elution of test substance and peptides was noticed. Complete depletion was caused by the positive control substance.

No co-elution of test substance and peptides was noticed. Based on the observed results and applying the prediction model proposed in Gerberick et. al (2007) and cited in chapter 3.10 it was concluded that the test item shows a minimal chemical reactivity in the DPRA under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:
other: Non peptide binding