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EC number: 677-829-5 | CAS number: 630-22-8
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May -July 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- The purpose of this study was to determine the eye irritation potential of the test item using the SkinEthic Reconstructed Human Corneal model (RHC, SkinEthic Laboratories, Nice, France) following treatment periods of 10 and 60 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The experimental design of the study consists of a test for Direct Reduction of MTT by the test item, followed by the main test.
For the main test, triplicate SkinEthic tissues were treated with the test item and exposed for 10 minutes and 60 minutes. The tissues were incubated at 37°C in a humidified atmosphere of 5% CO2 in air for the appropriate exposure period.
Duplicate tissues served as the negative control or positive control for each exposure period.
At the end of the 10-Minute exposure period each SkinEthic tissue was rinsed using Dulbecco’s Phosphate Buffered Saline (DPBS) and placed into a ‘holding plate’ until all the tissues had been rinsed. The rinsed tissues (two per group) were then transferred to an MTT ‘loading plate’, and incubated at 37°C for 3 hours in a humidified atmosphere of 5% CO2 in air. The remaining test item treated tissue was retained for possible histology. Following MTT loading, each SkinEthic tissue was blotted dry and placed into an MTT ‘extraction plate’ in order to extract all of the reduced MTT from the tissues. The same rinsing, retention, loading and extraction procedures were repeated for the 60-Minute tissues once the 60-Minute exposure period was complete.
At the end of the extraction period, the extracted MTT solution was mixed for each SkinEthic tissue and 3 x 200 μL samples, representing each tissue, were transferred to the appropriate wells of a 96 well plate. The optical density at 540nm (OD540) of each well was measured. Data are presented in the form of percentage viability (MTT conversion relative to negative controls) for each of the two exposure periods.
The results were used to make a prediction of the eye irritation potential of the test item. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-dimethylpropanethioamide
- EC Number:
- 677-829-5
- Cas Number:
- 630-22-8
- Molecular formula:
- C5H11NS
- IUPAC Name:
- 2,2-dimethylpropanethioamide
- Test material form:
- solid: crystalline
- Details on test material:
- Purity or Composition 100.0 %
Constituent 1
Test animals / tissue source
- Species:
- human
- Strain:
- other: SkinEthic Reconstructed Human Corneal model
- Details on test animals or tissues and environmental conditions:
- The SkinEthic RHC model consists of transformed human keratinocytes of the cell line HCE (LSU EYE Center, New Orleans, USA) that form a corneal epithelial tissue (mucosa), devoid of stratum corneum, resembling, histologically, the mucosa of the human eye.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10 and 60min
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Triplicate tissues were treated with the test item for exposure periods of 10 minutes and 60 minutes. 30 mg of the test item was topically applied to the corresponding tissues. The tissues were dosed at regular timed intervals, to allow for the period taken to rinse each insert following exposure, and to ensure each tissue received an equal exposure time. Duplicate tissues were treated with 30 μL of solution A to serve as negative controls for the 10 and 60-Minute exposure periods. Duplicate tissues were treated with 30 μL of SDS 0.5% w/v to serve as positive controls for the 10 and 60-Minute exposure periods. In order to eliminate the possibility of volatile test items affecting the viability of other treated tissues, the plates were sealed with a gas permeable sealing membrane. The plates were incubated at 37°C, 5% CO2 in air for the respective exposure times.
At the end of the relevant exposure period, each tissue insert was removed from the well using forceps and rinsed using a wash bottle containing DPBS. Rinsing was achieved by filling and emptying each tissue insert using a constant soft stream of DPBS to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the insert with absorbent paper. Each tissue was placed into a pre-labelled 24-well plate designated ‘holding plate’ containing 300 μL of maintenance medium (at room temperature) until all the tissues were rinsed (including the negative and positive control treated tissues). Following rinsing the tissues (two per group) were transferred to a pre-labelled 24-well plate designated ‘MTT Loading plate’ containing 300 μL of a 0.5 mg/mL MTT solution freshly prepared in maintenance medium. The MTT loading plate was placed into an incubator for three hours at 37°C, 5% CO2 in air.
At the end of the incubation period the inserts were blotted on absorbent paper to remove residual MTT solution and transferred to a pre-labelled 24-well plate designated ‘MTT extraction plate’ containing 0.75 mL of isopropanol in each of a sufficient number of wells. An extra 0.75 mL of isopropanol was added onto each tissue and the plate sealed to prevent Isopropanol evaporation. The plate was wrapped in aluminium foil (to protect from light) and allowed to stand overnight at room temperature to extract the formazan crystals out of the tissue.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test Item - Relative Mean Viability %
- Value:
- 94.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Negative Control Item - Relative Mean Viability %
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Positive Control Item - Relative Mean Viability %
- Value:
- 69.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The result of this study was combined with the result of a Rabbit Enucleated Eye Test, Harlan Laboratories Ltd Project number 41101184(2). The combined classification was Mild-Moderate Irritant, EU Risk Phrase R36 “irritating to eyes”, CLP Category 2, GHS: Category 2A.
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