Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-003-1 | CAS number: 9003-13-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 431.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 431 (2004)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-
- EC Number:
- 500-003-1
- EC Name:
- Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-
- Cas Number:
- 9003-13-8
- Molecular formula:
- (C3H6O)n C4H10O
- IUPAC Name:
- 9003-13-8
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of α-Butyl-ω-hydroxy-poly(oxy(methyl-1,2-ethanediyl)) (Polypropylene glycol monobutyl ether) and Tetramethyl-3,6,9,12-tetraoxahexadecan-1-ol (Tetrapropylene glycol n-butyl ether).
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EpiDerm Skin Model (EPI-200)
- Details on test animals or test system and environmental conditions:
- not applicable - in vitro assay
Test system
- Type of coverage:
- other: in vitro assay
- Preparation of test site:
- other: in vitro assay
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro assay
- Amount / concentration applied:
- Based upon MatTek Corporation’s recommended procedure, 50 μl of undiluted test material (liquids) were prepared and added on top of the skin tissues.
- Details on study design:
- The EpiDerm Skin Model (EPI-200). The model consisted of normal, human-derived epidermal kerotinocytes that were cultured to form an in vitro multilayered, highly differentiated model of the human epidermis. It consisted of organized basal, spinous, and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues were cultured on polycarbonate membranes of 10 mm cell culture inserts. Based upon MatTek Corporation’s recommended procedure, 50 μl of undiluted test material (liquids) were prepared and added on top of the skin tissues. The pH of the liquid test material was determined using both pH paper or pH meter. The test material(s) were administered by topical application to the EpiDerm skin tissue.
The skin tissues were placed in a refrigerator (4ºC) the day they were received. The next day, at least one hour before the assay was started the tissues were transferred to 6-well plates containing 0.9 ml DMEM medium per well. The medium was replaced with fresh DMEM medium just before test compound was applied. The test was performed on a total of four tissues per test substance in addition to a negative and positive control compound. Two tissues were used for a three minute exposure to the test compound, and two tissues were used for a one hour exposure. Fifty μl of the undiluted test substance were added into the 6-well plates on top of the skin tissues. The remaining tissues were treated with 50 μl Milli-Q water (negative control) or 50 μl 8N KOH (positive control). Following the respective exposure period, the tissues were carefully washed with phosphate buffered saline (PBS) to remove residual test substance. Rinsed tissues were kept in 24 well plates on 300 μl DMEM medium and placed into a humidified (37ºC, 5% CO2) incubator until all tissues (12 application time, including controls) were dosed for the particular period and rinsed. The DMEM medium was replaced by 300 μl MTTmedium and tissues were incubated for 3 hr at 37°C, 5% CO2. After incubation the tissues were washed with PBS and indicator formazan was extracted with 2 ml isopropanol over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 570 nm (OD570) in triplicate with a VMax® Microplate Reader (Molecular Devices).
According to the manufacture‘s instruction, a killed control test was performed to assess whether residual test substance (TPnB-H) was acting to directly reduce the MTT. To test for residual test article MTT reduction, a killed tissue (Freeze/Thaw method) was treated with the test article (TPnB-H) in the same manner as for the viable tissue. A single killed control treated with water (negative control killed control) was tested in parallel since a small amount of MTT reduction was expected from the residual NADH and associated enzymes within the killed tissue. If little or no MTT reduction was observed in the test article-treated killed control, the MTT reduction observed in the test article-treated viable tissue may be ascribed to the viable cells. If there was appreciable MTT reduction in the treated killed control (relative to the amount in the treated viable tissue), the mean raw absorbance will be corrected for the amount of MTT reduced directly by the test material residue to obtain a final corrected OD570 value.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: mean viability
- Basis:
- other: in vitro assay
- Time point:
- other: 3 minutes
- Score:
- > 50
- Remarks on result:
- other: more than 50% mean viability
- Irritation parameter:
- other: mean viability
- Basis:
- other: in vitro assay
- Time point:
- other: 1 hour
- Score:
- > 15
- Remarks on result:
- other: more than 15% mean viability
- Irritant / corrosive response data:
- The mean viability of DOWANOL™ TPnB-H Glycol Ether was more than 50% at three minutes and more than 15% at one hour, hence based on the EpiDerm prediction model for corrosion, DOWANOL™ TPnB-H Glycol Ether was classified as non-corrosive.
Any other information on results incl. tables
Mean tissue viability of DOWANOL™ TPnB-H Glycol Ether treatment following the three minute exposure period was 89.2% and following the one hour exposure period was 92.6%. The test material, DOWANOL™ TPnB-H Glycol Ether showed a slightly higher viability value at one hour exposure time. This result may be due to the test compounds’ interaction with MTT reagent and difficulty to remove them from cell surface after one hour incubation. The pH value of the neat test material was measured using pH strip and the value was between 8.0 to 8.5. The pH value of 50% solution of TPnB-H in water was measured with pH meter as 12.7. The results of killed control test indicated a little or no test substance remained in the cell after removing the test substance and washing the cell disc follow manufacture’s protocol. The OD570 values were 0.246 and 0.295 for water treated killed-disc and TPnBH treated killed-disc, respectively. The mean raw absorbance of negative control (water) and test substance were then corrected for the amount of MTT reduced directly by both test material residues to obtain a final corrected OD values. The mean raw absorbance of negative control (water) and test substance (TPnB-H) were corrected for the amount of MTT reduced directly by both test material residues to obtain a final corrected OD570 values. The % of control viabilities were calculated base on the final corrected OD570 values. The mean viability of DOWANOL™ TPnB-H Glycol Ether was more than 50% at three minutes and more than 15% at one hour, hence based on the EpiDerm prediction model for corrosion, DOWANOL™ TPnB-H Glycol Ether was classified as non-corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The mean tissue viability of DOWANOL™ TPnB-H Glycol Ether treatment following the three minute and one hour exposure periods were 89.2% and 92.6% respectively. Therefore, using the EpiDerm prediction model for corrosion DOWANOL™ TPnB-H Glycol Ether was classified as non-corrosive.
- Executive summary:
DOWANOL™ TPnB-H Glycol Ether was evaluated for skin corrosivity potential in an EpiDerm In Vitro corrosion assay which utilizes cultured human epidermal cells. In this assay, test material was topically applied to a three-dimensional regenerated human epidermis tissue for three minutes or one hour. Skin corrosion was then expressed as the remaining cell viability after exposure to the test substance. The tissue cell viability was measured using a standard cytotoxicity assay MTT (3-(4,5-dimethylthiazol-2-yl)-2,5- diphenyl tetrazolium bromide) and reported as a percentage of the mean of negative control. Skin corrosion potential of the test substance was classified according to tissue viability following exposure. A test substance is considered corrosive if the mean viability is less than 50% after three minutes or ≥ 50% at three minutes but less than 15% after one hour. Water served as a negative control and 8N potassium hydroxide was used as a positive control. The mean tissue viability of DOWANOL™ TPnB-H Glycol Ether treatment following the three minute and one hour exposure periods were 89.2% and 92.6% respectively. Therefore, using the EpiDerm prediction model for corrosion DOWANOL™ TPnB-H Glycol Ether was classified as non-corrosive.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.