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EC number: 817-828-0 | CAS number: 80322-82-3
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 - 18 March 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, Annex Part B, B.40Bis: "In Vitro Skin Corrosion: H uman Skin Model Test"
- Version / remarks:
- Official Journal of the European Union No. L142, amended by Commission Regulation (EU) 2019/1390 of 31 July 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro EpiDermTM Skin Corrosion Test, For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm
- Version / remarks:
- 27 July 2021
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid
- Cas Number:
- 80322-82-3
- Molecular formula:
- C8H18O8S2
- IUPAC Name:
- 2-[2-(2-hydroxyethoxy)ethoxy]ethanol,methanesulfonic acid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Reference substance name:
- 1,2-Ethandiylbis(oxy-2,1-ethandiyl)-monomethanesulfonat
- IUPAC Name:
- 1,2-Ethandiylbis(oxy-2,1-ethandiyl)-monomethanesulfonat
- Test material form:
- liquid
- Details on test material:
- Appearance: Dark yellow liquid
Batch No.: 01110008
Storage: -5 – 40 °C, container tightly closed, protected from light
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- Batch No.: 01110008
Storage: At room temperature (max 40 °C), protected from light
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ (EPI-200, MatTek, Ashland, MA, USA and Bratislava, Slovakia)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- In OECD Test Guideline No. 431 EpiDerm™ Skin Corrosivity Test (SCT) (EPI-200) is referred to as a Validated Reference Method that – based on prevalidation studies, followed by a formal validation study for assessing skin corrosion – could be used for regulatory purposes.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
Reconstructed Human Epidermis (RhE) Tissue
- Model used: EpiDerm™ (EPI-200, MatTek, Ashland, MA, USA and Bratislava, Slovakia)
- Supplier: MatTek In Vitro Life Science Laboratories Mlynské Nivy 73, 821 05 Bratislava, Slovakia
- Preparation of EpiDerm™ tissues: 16 March 2022
Standard Assay Kit Components
- Sealed 24-well and 12-well EpiDerm™ (EPI-200-SIT and EPI-212-SIT) plate
* Supplier: MatTek
* Lot Number: 36129
* Storage condition: Refrigerator (5±3 °C)
* Expiry date: 18 March 2022
- Assay medium (EPI-100-ASY)
* Supplier: MatTek
* Lot Number: 031022MJB
* Storage condition: Refrigerator (5±3 °C)
* Expiry date: 24 March 2022
PREPARATION OF EpiDerm™ TISSUE FOR TREATMENT
After the reception procedure of the test kit, the following steps were conducted before the treatment:
- After the medium has reached room temperature (the bottle of medium was placed for approximately 20 minutes to room temperature), the appropriate number of assay plate wells (6 well plates) were filled with the medium (0.9 mL per each well).
- Under sterile conditions, each insert, containing the epidermal tissue was taken out and any remaining agarose that adhered to the outer sides of the insert was removed by gentle blotting on the sterile filter paper or gauze.
- The quality of each insert was checked (unaided eye assessment). Neither tissue defect nor excess moisture on the surface was recorded.
- After the quality check, the surface of the tissues was dried with a sterile cotton tip swab and thereafter the inserts were transferred into the 6-well plates (pre-filled with 0.9 mL medium, upper row) and pre-incubated for 60 minutes at 37±1 °C in an incubator with 5±1 % CO2, 95±1 % humidified atmosphere.
- After incubation of 60 minutes, every tissue was transferred into the wells of the lower rows of the 6-well plates (pre-filled with 0.9 mL medium) and all 6-well plates were incubated at standard culture conditions (37±1 °C, 5±1 % CO2, 95±1 % humidified atmosphere) overnight.
APPLICATION/EXPOSURE
- Preparation of the holding plate: The appropriate number of assay plate wells (24-well plate / each exposure time) were filled with the assay medium (300 µL per well).
- Preparation for the application: After the overnight incubation, but before the application the integrity of the tissues was checked. After the quality check, the surface of the tissues was dried with a sterile cotton tip swab. Two replicates were used for the test item and each control, respectively in each exposure time.
- Test Item: A volume of 50 µL test item was applied evenly to the epidermal surface of each of the two test skin units. The test item was spread gently with the pipette tip in order to evenly cover all of the epidermal surface. Application of the nylon mesh was not necessary.
- Positive and negative control: A volume of 50 µL positive control (8N KOH solution) or negative control (sterile deionized water) were applied on the skin surface by using a suitable pipette. Chemicals were spread gently with the pipette tip in order to cover evenly all the epidermal surface. Application of the nylon mesh was not necessary.
- Additional controls for dyes and chemicals able to colour the tissue: In addition to the normal procedure, two additional test item treated tissues were used for the non-specific OD evaluation (NSCliving) in each exposure time.
- One hour exposure: The plates with the treated epidermis units were incubated for the exposure time of 60 minutes (+ 3 min) at standard culture conditions (37±1 °C, 5±1 % CO2, 95 % humidified atmosphere).
- 3 minutes exposure: The plates with the treated epidermis units were incubated for the exposure time of 3 minutes at room temperature. Each control was tested with every exposure time (60 and 3 minutes).
REMOVAL OF TEST MATERIAL
After the exposure time the EpiDermTM units were removed and rinsed thoroughly with 1x DPBS sterile solution to remove all of the test material from the epidermal surface. The constant soft stream of DPBS was used from approximately 1.5 cm distance, and filling and emptying the tissue insert was completed 20 times. The rest of the DPBS was decanted onto the absorbent material. Decanting was most efficiently performed by rotating the insert to approximately a 45° angle and touching the upper lip to the absorbent material (to break the surface tension).
Following rinsing tissues were transferred and kept in the 24-well holding plates (pre-filled with 300 µL medium) until the rinsing procedure was completed. The rest of the DPBS and/or test item was removed from the tissues by gently sweeping the tissues’ surface with a sterile cotton tipped swab (care was taken to avoid the damage of tissues).
MTT TEST
After the exposure of test item was terminated by rinsing with 1xDPBS, the EpiDerm™ units were transferred into the MTT ready to use solution filled 24-well plate (300 µL / per well) and then incubated for 3 hours (± 5 min) at 37±1 °C in an incubator with 5±1 % CO2, 95±1 % humidified atmosphere in the dark. An exception were the additional colour controls (NSCliving), whose wells were filled up with 300 µL assay medium (instead of MTT ready to use solution), the other steps remained the same.
FORMAZAN EXTRACTION
After the MTT incubation, the MTT medium was removed (gently aspirated) from all the wells with a Pasteur pipette (or suitable pipette tip) linked to a vacuum source. After removing all the possible amount of MTT medium the wells were refilled with 1xDPBS solution and were aspirated again. This rinsing process with DPBS was repeated twice and after the last aspiration the dryness of the tissue surface was checked and the inserts were transferred into the new 24-well plate. After the transportation, 2 mL extractant solution MTT-100-EXT (MTT-100 Assay Kit from MatTek) was pipetted into each well (extractant solution was flowing into the insert on the tissue surface). The plates were sealed with parafilm and were stored overnight at room temperature in the dark.
After the overnight storage the plates were placed on an orbital plate shaker and shaken (~120 rpm) for 2 hours at room temperature in each exposure time. At the end of the extraction period, the tissue was pierced and the liquid within each insert was allowed to run into the well from which it was taken.
CELL VIABILITY MEASUREMENTS
Following the formazan extraction the extracts were homogenized by pipetting them up and down 3 times, then 2x200 µL samples from each well from the 24-well plate were pipetted into the wells of a 96-well plate. The Absorbance / Optical Density (OD) of the samples was read in the spectrophotometer at the wavelength of 570 nm using MTT-100-EXT solution as the blank (6×200 µL).
PREDICTION MODEL / DECISION CRITERIA
STEP 1
- The test substance is considered to be non-corrosive to skin if mean tissue viability is >= 50 % after 3 min exposure AND >= 15% after 60 min exposure
- The test substance is considered to be corrosive to skin if mean tissue viability is < 50 % after 3 min exposure OR >= 50 % after 3 min exposure AND < 15 % after 60 min exposure
STEP 2 for materials identified as Corrosive in STEP 1
- The test substance is considered corrosive to skin (Sub-category 1A) if mean tissue viability is < 25 % after 3 min exposure
- The test substance is considered corrosive to skin (Sub-category 1B or 1C) if mean tissue viability is >= 25 % after 3 min exposure - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 µL
VEHICLE
No vehicle
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 448 g/L (g KOH/L H2O)
POSITIVE CONTROL
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- 60 and 3 minutes for test item, positive control and negative control
- Duration of post-treatment incubation (if applicable):
- no post-treatment incubation
- Number of replicates:
- Two replicates were used for the test item and controls, respectively
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 minutes exposure
- Run / experiment:
- mean
- Value:
- 72
- Negative controls validity:
- valid
- Remarks:
- 100% viability, SD 3.027
- Positive controls validity:
- valid
- Remarks:
- valid 2% viability, SD 0.123
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 minutes exposure
- Run / experiment:
- mean
- Value:
- 99
- Negative controls validity:
- valid
- Remarks:
- 100% viability, SD 8.203
- Positive controls validity:
- valid
- Remarks:
- valid 12% viability, SD 0.625
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- INDICATOR FOR POTENTIAL FALSE VIABILITY
- Possible direct MTT reduction with test item: Colour change was not observed after one hour of incubation. The test item did not interact with the MTT, therefore additional controls and data calculations were not necessary. A false estimation of viability can be precluded.
- Colouring potential of test item: The test item has an intrinsic colour (dark yellow). If the test item is not white, off white, almost white and/or colorless the additional controls are automatically used and based on the OD results of additional controls the Non Specific Colour % (NSCliving %) is determined. This step prevents from a false viability, which can possibly be caused by the stained surface of the tissues by the test item. Two additional test item-treated tissues were used in each exposure time (60 and 3 minutes) for the non-specific OD evaluation. Mean OD (measured at 570 nm) of these tissues was 0.005 and 0.002 at 60 and 3 minutes exposure respectively. The Non Specific Colour living % (NSCliving %) was calculated 0% at each exposure. Both results were under the threshold value (5%), so the correction with the NSCliving % was not necessary. A false estimation of viability can be precluded.
VALIDITY OF THE TEST
- Acceptance criteria met for negative control tissues (OD between 0.8 and 2.8): Yes, mean OD value of the two negative control tissues was 1.746 and 1.568 at 60 and 3 minutes exposure respectively.
- Accpetance criteria met for positive control (mean % viability after 1hr exposure <= 15%): Yes, mean OD value obtained for the positive control was 0.027 at 60 minutes exposure which result corresponds to 2 % viability, when compared to the results obtained from the negative control.
- Acceptance criteria met for variability between tissue replicates (CV <= 30% within the range of 20 - 100% viability): Yes, each calculated Coefficient of Variation value (CV) in the range of 20-100 % viability was below 30.
- Acceptance criteria met for mean OD value of blank samples (<0.1): Yes, mean OD value of the blank samples MTT-100-EXT were 0.0341 and 0.0340 at 60 and 3 minutes exposure (below 0.1).
All validity criteria were within acceptable limits and therefore the study was considered as valid.
Any other information on results incl. tables
Cell viability
The results of the optical density (OD) measured at 570 nm of each replicate and the calculated % viability of the cells is presented below:
- OD values and viability percentages of the controls:
Controls | Optical Density (OD) | Viability (%) | |
Negative Control: Sterile deionized water 60 min exposure | 1 2 | 1.709 1.784 | 98 102 |
mean | 1.746 | 100 | |
SD | / | 3.027 | |
CV | / | 3.027 | |
Negative Control: Sterile deionized water 3 min exposure | 1 2 | 1.477 1.658 | 94 106 |
mean | 1.568 | 100 | |
SD | / | 8.203 | |
CV | / | 8.203 | |
Positive Control: Potassium hydroxide (KOH) 8N solution 60 min exposure | 1 2 | 0.028 0.025 | 2 1 |
mean | 0.027 | 2 | |
SD | / | 0.123 | |
CV | / | 8.060 | |
Positive Control: Potassium hydroxide (KOH) 8N solution 3 min exposure | 1 2 | 0.196 0.182 | 13 12 |
mean | 0.189 | 12 | |
SD | / | 0.625 | |
CV | / | 5.176 |
- OD values and viability percentages of the test item:
Test Item | Optical Density (OD) | Viability (%) | |
Triethylene glycol dimethanesulfonate 60 min exposure | 1 2 | 1.430 1.101 | 82 63 |
mean | 1.265 | 72 | |
SD | / | 13.323 | |
CV | / | 18.390 | |
Triethylene glycol dimethanesulfonate 3 min exposure | 1 2 | 1.721 1.370 | 110 87 |
mean | 1.545 | 99 | |
SD | / | 15.836 | |
CV | / | 16.065 |
Mean blank OD values were 0.0341 and 0.0340 at 60 and 3 minutes exposure respectively.
- OD values and NSCliving % of additional controls:
Test Item | Optical Density (OD) | Non Specific Colour % (NSCliving %) | |
Triethylene glycol dimethanesulfonate 60 min exposure | 1 2 | 0.008 0.002 | 0 0 |
mean | 0.005 | ||
Triethylene glycol dimethanesulfonate 3 min exposure | 1 2 | 0.001 0.003 | 0 |
mean | 0.002 |
Mean blank OD values were 0.0341 and 0.0340 at 60 and 3 minutes exposure respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: The test substance can be classified as Non-corrosive. However, skin irritation potential cannot be excluded. The study is used for classification in a weight of evidence approach.
- Conclusions:
- In conclusion, in this in vitro skin corrosion test in EpiDermTM model (OECD 431) with Triethylene glycol dimethanesulfonate (CAS-No. 80322-82-3), the results indicate that the test item is not corrosive. According to the UN GHS classification system, Triethylene glycol dimethanesulfonate can be classified as “Non-corrosive”.
- Executive summary:
Disks of EpiDermTM (two units / chemical / incubation time) were treated with the test item and incubated for 60 minutes (+ 3 min) at standard culture condition (37±1 °C in an incubator with 5±1 % CO2 in a 95 % humidified atmosphere) and for 3 minutes at room temperature. Exposure of test material was terminated by rinsing with 1x DPBS solution. The viability of each disk was assessed by incubating the tissues for 3 hours (±5 min) with MTT solution at 37±1 °C in an incubator with 5±1 % CO2 in a 95 % humidified atmosphere and protected from light. An exception were the additional colour controls (NSCliving), whose wells were filled up with 300 μL assay medium (instead of MTT ready to use solution), the other steps remained the same. The formazan precipitated was then extracted using MTT-100-EXT and quantified spectrophotometrically.
The test item has an intrinsic colour (dark yellow), therefore two additional test item treated tissues were used for the non-specific OD evaluation (NSCliving) in each exposure time.
Potassium hydroxide (KOH) 8N solution and sterile deionized water treated (two units / positive and negative control) epidermis were used as positive and negative controls, respectively in the experiment.For each treated tissue viability was expressed as a % relative to negative control. The test item is considered to be non-corrosive to skin, if the mean relative viability after 60 minutes of exposure is above or equal to 15 % and the mean relative viability after 3 minutes of exposure is above or equal to 50 % of the negative control.
The test item did not show significantly reduced cell viability in comparison to the negative control after 60 and 3 minutes exposure. The average test item treated tissue mean viability was 72 % at 60 minutes of exposure and the mean viability was 99 % at 3 minutes of exposure.
Positive and negative controls showed the expected optical density (OD) in the experiment and cell viability values within acceptable limits. All assay acceptance criteria were met, the experiment was considered to be valid.
In conclusion, in this in vitro skin corrosion test in EpiDermTM model (OECD 431) with Triethylene glycol dimethanesulfonate (CAS-No. 80322-82-3), the results indicate that the test item is not corrosive. According to the UN GHS classification system, Triethylene glycol dimethanesulfonate can be classified as “Non-corrosive”.
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