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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:
2015

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
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Sovermol Pol 1100
- Test-substance No.: 14/0220-1
- Physical state: liquid
- Lot/batch No.: L82

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 rthylene glycol dimethacrylate.

Any other information on results incl. tables

The mean Cysteine-peptide depletion, caused by the test substance was determined to be 4.88 %.

The mean Lysine-peptide depletion, caused by the test substance was determined to be -1.04%.

Negative depletions were considered to be “zero” for calculation of the mean peptide depletion, which was thus calculated to be 2.44%.

No co-elution of test substance and peptides was noticed.

Applicant's summary and conclusion

Interpretation of results:
other: Non peptide binding
Conclusions:
Non peptide-binding