Registration Dossier
Registration Dossier
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EC number: 288-927-9 | CAS number: 85940-40-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Remarks:
- DPRA test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Principles of method if other than guideline:
- Gerberick GF, Vassallo JD, 8ailey RE, Chaney JG, Morrall SW, Lepoittevin JP.
Development of a Peptide Reactivity Assay for Screening Contact Allergens.
Toxicological Seiences 81 ,332-343, 2004.
Gerberick GF, Vassallo JD, Foertsch LM, Price 88, Chaney JG, Lepoittenvin JP.
Quantificationn of Chemical Peptide Reactivity for Screening Contact Allergens: A
Classification Tree Model Approach. Toxicological Seiences 97(2), 417-427, 2007.
Bauch C, Kolle SN, Fabian E, Pachel C, Ramirez T, Wiench B, Wruck CJ , van
Ravenzwaay B, Landsiedei R. lntralaboratory validation of four in vitro assays for
the prediction of the skin sensitizing potential of chemicals. Toxicology in Vitro 25,
1162 - 1168, 2011.
Maxwell G, Aeby P, Ashikaga T, Bessou-Touya S, Diembeck W, Gerberick F,
Kern P, Marrec-Fairley M, Ovigne JM, Sakaguchi H, Schroeder K, Tailhardat M,
Teissier S, Winkler P. Skin sensitisation: the Colipa strategy for developing and
evaluating non-animal test methods for risk assessment. AL TEX 28(1 ): 50-5,
2011. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: direct peptide reactivity assay
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- EC Number:
- 288-927-9
- EC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Cas Number:
- 85940-40-5
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Test material form:
- liquid: viscous
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Parameter:
- cysteine depletion
- Remarks:
- mean depletion (%)
- Value:
- 0 %
Any other information on results incl. tables
Result: minimal reactivity
mean peptide depletion = 0%
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
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