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EC number: 610-161-4 | CAS number: 4403-36-5
- 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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: sensitising based on weight of evidence from 2 in chemico/in vitro studies.
- positive in DPRA (OECD 442C, GLP)
- positive in KeratinoSens (OECD 442D, GLP)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
In chemico/in vitro skin sensitisation
There are two studies available, in which the substance was tested in chemico and in vitro for potential induction of skin sensitisation. All three studies were conducted under GLP conditons and in accordance with OECD Guidelines 442C (DPRA) and 442D (KeratinoSens).
- Direct Peptide Reactivity Assay (DPRA)
The objective of this study was to determine the reactivity of TA-2 towards model synthetic peptides containing either cysteine (SPCC) or lysine (SPCL). After incubation of the test item with either SPCC or SPCL, the relative peptide concentration was determined by High-Performance Liquid Chromatography (HPLC) with gradient elution and photodiode array (PDA) detection at 220 nm and 258 nm. SPCC and SPCL Percent Depletion Values were calculated and used in a prediction model which allows assigning the test item to one of four
reactivity classes used to support the discrimination between sensitizers and non-sensitizers. The study procedures described in this report were based on the most recent OECD guideline.
In the cysteine reactivity assay the test item showed 100.0% SPCC depletion while in the lysine reactivity assay the test item showed 23.4% SPCL depletion. The mean of the SPCC and SPCL depletion was 61.7% and as a result the test item was considered to be positive in the DPRA and classified in the “high reactivity class” when using the Cysteine 1:10 / Lysine 1:50 prediction model.
- KeratinoSens™ Assay
The objective of this study was to evaluate the ability of TA-2 to activate the antioxidant/electrophile responsive element (ARE)-dependent pathway in the KeratinoSens™assay.
Cells were incubated with the test item in a concentration range of 0.98 – 2000 µM (2-fold dilution series) for 48 hours ± 1 h. The activation of the ARE-dependent pathway was assessed by measuring the luminescence induction compared to the vehicle control. In addition, the viability was assessed with an MTT assay.
TA-2 showed toxicity (IC 30 values of 1156 µM and 975 µM and IC 50 values of 1398 µM and 1031 µM in experiment 1 and 2, respectively). A biologically relevant, dose-related induction of the luciferase activity (EC 1.5 values of 575 µM and 609 µM in experiment 1 and 2, respectively) was measured in both experiments. The maximum luciferase activity induction (I max ) was 5.91-fold and 26.10-fold in experiment 1 and 2 respectively. TA-2 is classified as positive in the KeratinoSens™assay since positive results (>1.5-fold induction)
were observed at biologically relevant concentrations (EC 50 value < 1000 µM) with a cell viability of >70% compared to the vehicle control.
In conclusion, the test item is classified as positive (activation of the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes) under the experimental conditions of the study.
Based on the weight of evidence from the two available in chemico/in vitro studies, the substance is considered to be skin sensitising.
Justification for classification or non-classification
The available data indicate that the substance does meet the classification criteria for skin sensitisation in accordance with Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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