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EC number: 815-596-5 | CAS number: 1613307-27-9
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9th September 2013 to 12th November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
- Principles of method if other than guideline:
- The MalTek EpiDerm™ MTT Viability Assay has been demonstrated to be a quantitative method for assessing potential skin hazards.
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethyl 2-(3-chloro-5-cyanophenoxy)acetate
- EC Number:
- 815-596-5
- Cas Number:
- 1613307-27-9
- Molecular formula:
- C11H11CINO3
- IUPAC Name:
- ethyl 2-(3-chloro-5-cyanophenoxy)acetate
- Test material form:
- solid
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: not specified
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test articles were dosed neat.
A Negative Control, 100 μI of tissue culture water, was tested concurrently.
A Positive Control (1% Triton" X-100) was tested concurrently. - Duration of treatment / exposure:
- The test article, the positive control (1% Triton" X-100), and the negative control tissue culture water), were treated in duplicate EpiDermTM tissues for 1,4 and 24 hours. A Negative Control (undosed tissues) was tested at 4 hours. A Positive Control (1% Triton" X-100) was tested at 4 and 9 hours.
- Duration of post-treatment incubation (if applicable):
- At the end of the selected exposure periods, each EpiDerm™ tissue was rinsed with phosphate
buffered saline (PBS) and transferred to a 24-well plate containing 300 μI of MTT solution (1 mg/ml MTT in DMEM). The tissues were then returned to the incubator for a three-hour MTT incubation period. Following the MTT incubation period, each EpiDerm™ tissue was rinsed with PBS and then treated overnight with 2.0 ml of extractant solution (isopropanol) per well. - Number of replicates:
- Duplicate
Test system
- Details on study design:
- Test Article Reduction of MTT:
For each test article, 100 mg of the test article were mixed with 1 ml of MTT solution (1 mg/ml Methyl thiazole tetrazolium diluted in Dulbecco's Modified Eagle's Medium (DMEM»). A Negative Control, 100 μI of tissue culture water, was tested concurrently. The solutions were incubated at room temperature in the dark for 60 minutes. After incubation, the solutions were visually inspected for purple coloration, which indicates that the test article reduced MTT. Since tissue viability is based on MTT reduction, direct reduction by a test article can exaggerate viability, making a test article seem less irritating than it really is None of the test articles were found to have reduced MTT and the assay continued as per the protocol.
Tissue Viability (MTT Reduction):
At the end of the selected exposure periods, each EpiDerm™ tissue was rinsed with phosphate
buffered saline (PBS) and transferred to a 24-well plate containing 300 ~I of MTT solution (1 mg/ml MTT in DMEM). The tissues were then returned to the incubator for a three-hour MTT incubation period. Following the MTT incubation period, each EpiDerm™ tissue was rinsed with PBS and then treated overnight with 2.0 ml of extractant solution (isopropanol) per well. An aliquot of the extracted MTT formazan was measured at 540 nrn using a plate reader, subtracting the absorbance at a reference wavelength of 690 nm.
Analysis of Data:
The mean absorbance value for each time point was calculated from the optical density (00) of the duplicate samples and expressed as percent viability for each sample using the following formula:
% viability = 100 X (00 sample/OD Negative Control)
The ET50, the time at which the EpiDerm ™ tissue viability was reduced 50% compared to Control tissues, was then determined using a macro in Microsoft Excel 5.0, provided by MatTek, using the equation: V=a+blogt
Where V =percentage viability, t =time in hours, and a and b are constants that can be determined by using the viability data for two different exposure times of the test article to the tissue. These exposure times must yield viabilities that flank 50%.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: ET50
- Run / experiment:
- L-005183690-000F003
- Value:
- 21
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Very mild
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- L-005183690-000F003 - Very Mild
- Executive summary:
OBJECTIVE: To provide an estimate of dermal irritation potential using an alternative to the Draize methodology. The MalTek EpiDerm™ MTT Viability Assay has been demonstrated to be a quantitative method for assessing potential skin hazards.
METHOD SYNOPSIS: MatTek EpiDerm ™ tissue samples were treated in duplicate with the test articles and Positive Control for various exposure times listed below. Negative Controls (undosed tissues) were tested at4 hours only. Following treatment, the viability of the tissues was determined using Methyl thiazole tetrazolium (MTT) uptake and reduction. The absorbance of each sample was measured at 540 nm using a reference wavelength of 690 nm. The viability was then expressed as a percent of Control values. The mean percent viability for each time point was used to calculate an ET50, which represents the time at which the EpiDerm TM tissue viability was reduced 50% compared to Negative Control tissues. The ET50 scores were converted to an irritancy classification.
SUMMARY/CONCLUSION:L-005183690-000F003 Very Mild
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