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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP but not guideline compliant. There are no national or international guidelines for the DPRA Assay.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Principles of method if other than guideline:
There are no official national or international guidelines for the DPRA Test; however, the study is performed according to the methods described in the following publications:  Gerberick GF, Vassallo JD, Bailey RE, Chaney JG, Morrall SW, Lepoittevin JP. Development of a Peptide Reactivity Assay for Screening Contact Allergens. Toxicological Sciences 81,332-343, 2004.  Gerberick GF, Vassallo JD, Foertsch LM, Price BB, Chaney JG, Lepoittenvin JP. Quantificationn of Chemical Peptide Reactivity for Screening Contact Allergens: A Classification Tree Model Approach. Toxicological Sciences 97(2), 417-427, 2007.  Bauch C, Kolle SN, Fabian E, Pachel C, Ramirez T, Wiench B, Wruck CJ, van Ravenzwaay B, Landsiedel R. Intralaboratory validation of four in vitro assays for the prediction of the skin sensitizing potential of chemicals. Toxicology in Vitro 25, 1162 – 1168, 2011.
GLP compliance:
yes (incl. QA statement)
Type of study:
other: Direct Peptide Reactivity Assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexahydro-4,7-methano-1H-indenyl acrylate
EC Number:
235-697-2
EC Name:
Hexahydro-4,7-methano-1H-indenyl acrylate
Cas Number:
12542-30-2
Molecular formula:
C13 H16 O2
IUPAC Name:
2-Propenoic acid hexahydro-4,7-methano-1H-indenyl ester
Details on test material:
- Name of test material (as cited in study report): Dihydrodicyclopentadienylacrylate
- Physical state: liquid
- Analytical purity: 97.9 %
- Lot/batch No.: 110019P040

Results and discussion

Any other information on results incl. tables

The test substance was soluble in acetonitrile. However when mixed with the peptide stock solution the samples of the C-peptide became cloudy directly after preparation. After 24 hours precipitates were noticed in the samples of both peptides, additionally. Thus the samples of both peptides were centrifuged prior to HPLC analysis.

The mean C-peptide depletion, caused by the test substance was determined to be 100%.

The mean K-peptide depletion, caused by the test substance was determined to be 57.2%.

Thus, the mean peptide depletion was calculated to be 78.6%. Based on the observed results and applying the prediction model proposed in Gerberick et. al (2007) it was concluded that Dihydrodicyclopentadienylacrylate shows a high chemical reactivity in the DPRA under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:
other: shows a high chemical reactivity