Registration Dossier
Registration Dossier
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EC number: 210-276-6 | CAS number: 611-71-2
Skin sensitisation
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:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 442C (adopted 4 February 2015): In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Direct peptide binding assay
Test material
- Reference substance name:
- L-2-hydroxy-2-phenylacetic acid
- EC Number:
- 210-276-6
- EC Name:
- L-2-hydroxy-2-phenylacetic acid
- Cas Number:
- 611-71-2
- Molecular formula:
- C8H8O3
- IUPAC Name:
- hydroxy(phenyl)acetic acid
- Details on test material:
- - Name of test material (as cited in study report): L-2-Hydroxy-2-phenylacetic acid
- Physical state: solid (white)
- Analytical purity: 99.972 area%
- Lot/batch No.: 12-0001
Constituent 1
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
- Route:
- other: in vitro
- Vehicle:
- other: acetonitrile
Challenge
- Route:
- other: in vitro
- Vehicle:
- other: acetonitrile
Results and discussion
- Positive control results:
- All peptide was depleted by the positive control substance Ethylene glycol dimethacrylate.
Any other information on results incl. tables
The mean Cysteine-peptide depletion, caused by the test substance was determined to be 1.57%.
The mean Lysine-peptide depletion, caused by the test substance was determined to be -0.69%.
Negative depletions were considered to be “zero” for calculation of the mean peptide depletion, which was thus calculated to be 0.79%.
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) it was concluded that L-2-Hydroxy-2-phenylacetic acid shows a minimal chemical reactivity in the DPRA under the test conditions chosen.
Due to the complexity of the skin sensitization process a single in vitro assay is not sufficient to adequately assess this toxicological endpoint. Therefore, a combination of several methods addressing key events of the sensitization process: protein reactivity (DPRA), activation of keratinocytes (LuSens or KeratinoSens) and activation of dendritic cells (MUSST or h-CLAT) were used (test battery).
The in vitro sensitization turnkey strategy was initiated with the DPRA and the LuSens. As an unambiguous result was obtained after these two tests, no further test was performed. The results of the individual studies are summarized and evaluated in scientific strategy (see Enspoint summary Sensitization).
Applicant's summary and conclusion
- Interpretation of results:
- other: Non peptide binding/peptide binding
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