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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2015
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

Constituent 1
Chemical structure
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

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