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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 837-816-9 | CAS number: 10438-94-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Sep 2019 to 13 Sep 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 31 may 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(octyloxy)propane-1,2-diol
- Cas Number:
- 10438-94-5
- Molecular formula:
- C11H24O3
- IUPAC Name:
- 3-(octyloxy)propane-1,2-diol
- Test material form:
- liquid
- Details on test material:
- Storage Conditions: At room temperature protected from light container flushed with nitrogen.
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: epidermal keratinocytes
- Cell source:
- other: MatTek Corporation, Ashland MA, U.S.A.
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): EPI-200, Lot no.: 30964 kits D and E
- Production date: 11 Sep 2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 minutes at room temperature, 1 hour incubation at 37.0 ± 1.0ºC.
- Temperature of post-treatment incubation: All incubations, with the exception of the test item incubation of 3 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 62 - 88%, containing 5.0 ± 0.5% CO2 in air in the dark at 36.3 - 37.1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: one step, washing done with PBS
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/mL) diluted (1:5) with MTT diluent (supplemented DMEM).
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES:
- 4 tissues per test item together with a negative control and positive control. Two tissues were used for a 3-minute exposure and two for a 1-hour exposure period.
- For the negative and positive controls, 2 tissues were treated with 50 µL Milli-Q water (negative control) and 2 tissues were treated with 50 µL 8N KOH (positive control) for both the 3-minute and 1-hour time point.
ACCCEPTABILITY CRITERIA
The in vitro skin corrosion test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the two tissues of the negative control should reasonably be within the laboratory historical control data range and the acceptance limits of OECD431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8).
b) The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
c) In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤30%.
DECISION CRITERIA
The test substance is considered to be corrosive to skin if:
- The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%
- In addition, a test item considered non-corrosive (viability ≥ 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
A test item is considered non corrosive in the in vitro skin corrosion test if:
- The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
- In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL of the undiluted test item was added into the 6-well plates on top of the skin tissues
VEHICLE
Not applicle - Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes treatment
- Value:
- 58
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- mean tissue viability: 17%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 Hour treatment
- Value:
- 78
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- mean tissue viability: 11%
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was 1.599 after the 3 minute treatment and 1.497 after the 1 hour treatement which was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range (3 min treatment 1.258 - 2.615; 1 hour treatment 1.371 - 2.371).
- Acceptance criteria met for positive control:
The mean relative tissue viability following the 1-hour exposure to the positive control was 11%.
- Acceptance criteria met for variability between replicate measurements:
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 17%, indicating that the test system functioned properly.
Any other information on results incl. tables
Table1
Mean Absorption in the in vitro Skin Corrosion Test with the test item
|
3-minute application |
1-hour application |
||||||||
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
A (OD570) |
B (OD570) |
Mean (OD570) |
SD |
|||
Negative control |
1.653 |
1.545 |
1.599 |
± |
0.076 |
1.480 |
1.513 |
1.497 |
± |
0.023 |
Test item |
0.833 |
1.008 |
0.920 |
± |
0.123 |
1.094 |
1.253 |
1.174 |
± |
0.1130 |
Positive control |
0.237 |
0.305 |
0.271 |
± |
0.048 |
0.191 |
0.134 |
0.162 |
± |
0.041 |
SD = Standard deviation
Duplicate exposures are indicated by A and B.
Table2
Mean Tissue Viability in the in vitro Skin Corrosion Test with the test
item
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Test item |
58 |
78 |
Positive control |
17 |
11 |
Table3
Coefficient of Variation between Tissue Replicates
|
3 minute |
1 hour |
Negative control |
6.5 |
2.2 |
Test item |
17 |
13 |
Positive control |
22 |
30 |
CV (%) = 100 - [(lowest OD570/highest OD570) x 100%]
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- The results of an in vitro skin corrosion test performed according to OECD TG 431 showed that the substance was not corrosive to the skin.
- Executive summary:
An in vitro skin corrosion test was performed following OECD TG 413 and in accordance with GLP principles. The test item was applied undiluted (50 µL) directly on top of the skin tissue for 3 minutes or 1 hour. After exposure the skin tissue is thoroughly rinsed to remove the test item followed by an immediate determination of the cytotoxic effect using MTT.
The positive control had a mean relative tissue viability of 11% after the 1-hour exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues waswithin the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 17%,indicating that the test system functioned properly. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Saskine TM 80 compared to the negative control tissues was 58% and 78%, respectively. Because the mean relative tissue viability was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the substance is considered to be not 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.