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Diss Factsheets
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EC number: 241-240-8 | CAS number: 17199-29-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2015-September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Version / remarks:
- Ramirez T, Mehling A, Kolle SN, Wruck CJ, Teubner W, Eltze T, Aumann A, Urbisch D, Ravenzwaay BV, Landsiedel R.., LuSens: A keratinocyte based ARE reporter gene assay for use in integrated testing strategies for skin sensitization hazard identification. Toxicol In Vitro. 2014 Dec;28(8).
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Version / remarks:
- OECD: Draft Proposal for a New Guideline on In Vitro Skin Sensitization: human Cell
Line Activation Test (h-CLAT), accessed on 01 Sep 2014 at http://www.oecd.org
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Version / remarks:
- Ashikaga T, Sakaguchi H, Sono S, Kosaka N, Ishikawa M, Nukada Y, Miyazawa , Ito Y, Nishiyama N, Itagaki H. (2010) A comparative evaluation of in vitro skin sensitisation tests: the human cell-line activation test (h-CLAT) versus the local lymph node assay (LLNA). Altern Lab Anim. 38(4):275-84.
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Version / remarks:
- Sakaguchi H, Ryan C, Ovigne JM, Schroeder KR, Ashikaga T. (2010) Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials. Toxicol In Vitro. 24(6):1810-20.
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Version / remarks:
- Bauch C, Kolle SN, Ramirez T, Eltze T, Fabian E, Mehling A, Teubner W, van Ravenzwaay B, Landsiedel R, (2012), Putting the parts together: Combining in vitro methods to test for skin sensitizing potentials, Regul Toxicol Pharmacol, 63(3):489-504.
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Version / remarks:
- Urbisch D, Mehling A, Guth K, Ramirez T, Honarvar N, Kolle SN, Landsiedel R, Jaworska J, Kern P, Gerberick F, Natsch A, Emter R, Ashikaga T, Miyazawa M, Sakaguchi H. Assessing skin sensitization hazard in mice and men using non-animal test methods. Regulatory Toxicology and Pharmacology 71(2), 135-352. 2015.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay and In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method
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
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 12-0001
- Purity test date: 99.972 area-% (HPLC, chiral)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Results and discussion
In vitro / in chemico
Results
- Parameter:
- other: sensitisation
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- Acceptance criteria of the DPRA:
The acceptance criteria mentioned in section 3.9.1 were met with the exception of the vehicle control B analyzed at the end of the sample list. The average is just below the acceptance criterion 0.50 mM ± 0.05 mM. However, the deviation was minimal, and as all other acceptance criteria were met, peptide stability was considered to be acceptable.
Table 18: Historic control data of negative control / vehicle control acetonitrile.
Table 19: Historic control data of positive control EGDMA 50 mM in acetonitrile.
Historic Period
mean peptide
concentration
[mM]
SD of peptide
concentration
Jan 2012 - Aug 2015 (no. of tests performed: 82)
Cysteine-peptide 0.485 0.023
Lysine-peptide 0.502 0.015
Historic Period
mean peptide
concentration
[mM]
SD of peptide
concentration
mean peptidedepletion
[%]
SD of peptidedepletion
[%]
Feb 2012 - Aug 2015 (no. of tests performed: 60)
Cysteine-peptide 0.199 0.047 59 10
Lysine-peptide 0.434 0.028 14 5
Acceptance criteria of the LuSens
The acceptance criteria mentioned in section 3.9.2 were met in all experiments.
The positive and negative and vehicle control data is comparable to historic data as can be seen in the following table:
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the observed results and applying the evaluation criteria described in chapter 3.10, L-2-Hydroxy-2-phenylacetic acid is not peptide reactive and does not activate keratinocytes. Applying the evaluation criteria described in chapter 3.10 L-2-Hydroxy-2-phenylacetic acid is predicted not to be a skin sensitizer.
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