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EC number: 211-915-1 | CAS number: 710-04-3
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June 2018 - 25 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 20 July 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrahydro-6-propyl-2H-pyran-2-one
- EC Number:
- 211-820-5
- EC Name:
- Tetrahydro-6-propyl-2H-pyran-2-one
- Cas Number:
- 698-76-0
- Molecular formula:
- C8H14O2
- IUPAC Name:
- 6-propyloxan-2-one
- Test material form:
- liquid
- Details on test material:
- Appearance: Clear colourless to pale yellow liquid
Storage: In refrigerator (2-8°C)
Constituent 1
- Specific details on test material used for the study:
- No purity correction factor was used.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small Model(TM) (EPISKIN-SM(TM), 0.38 cm^2)
- Tissue batch number(s): 18-EKIN-025
- Expiration date: 25 June 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 36.6 - 37.3°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: once with phosphate buffered saline
- Observable damage in the tissue due to washing: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Histology scoring: 22.4 +/- 0.4
- Satisfactory epidermis layer
- Contamination: on blood of the same donors it was verified that there was an absence of HIV 1 and 2 antibodies, hepatitis C antibodies, hepatitis B antigen HBs. On epidermal cells of the same donors it was verified that there was an absence of bacteria, fungus and mycoplasma.
NUMBER OF REPLICATE TISSUES: 3 replicates for the test item, positive control and negative control exposed skin tissues each. OD measurements on each replicate were performed in duplicate.
MTT DIRECT INTERFERENCE:
- The test item was checked for direct MTT reduction and interference in a previous study and was concluded that it did not interfere with the MTT endpoint.
PREDICTION MODEL / DECISION CRITERIA (see table 1)
A test item is considered irritant in the skin irritation test if:
- The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is ≤ 50% of the mean viability of the negative controls.
A test item is considered non-irritant in the in vitro skin irritation test if:
- The relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls.
ACCEPTABILITY CRITERIA:
- The absolute mean OD570 (optical density at 570 nm) of the three tissues of the negative control should reasonably be within the laboratory historical control data range and the Standard Deviation value (SD) of the % viability should be ≤18.
- The mean relative tissue viability of the positive control should be ≤40% relative to the negative control and the Standard Deviation value (SD) of the % viability should be ≤18.
- The SD calculated from individual % tissue viabilities of the three identically treated replicates should be ≤18. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - Test item: 25 µL
- Positive control: 25 µL
- Negative control: 25 µL (re-spread after 7 minutes contact time) - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours, followed by 3 hours with MTT
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of 3 replicates
- Value:
- 62
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, the absolute mean OD570 of the negative control tissues was within the laboratory historical control data range (see table 3)
- Acceptance criteria met for positive control: yes, the positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 7.3%.
- Acceptance criteria met for variability between replicate measurements: yes, the standard deviation value of the percentage viability of three tissues treated identically was ≤ 11%
Any other information on results incl. tables
Table 2 Individual OD Measurements at 570 nm
|
A (OD570) |
B (OD570) |
C (OD570) |
Negative control OD570measurement 1 OD570measurement 2 |
1.0123 0.9921 |
0.9900 0.9680 |
1.0793 1.0356 |
Test item OD570measurement 1 OD570measurement 2 |
0.7848 0.7585 |
0.5607 0.5470 |
0.6308 0.6106 |
Positive control OD570measurement 1 OD570measurement 2 |
0.1118 0.1180 |
0.1221 0.1175 |
0.0982 0.1070 |
OD = Optical density
Triplicate exposures are indicated by A, B and C.
Table 3 Historical data
|
Negative control (absorption; OD570) |
Positive control (absorption; OD570) |
Range |
0.422 – 1.547 |
0.023 – 0.437 |
Mean |
0.98 |
0.13 |
SD |
0.18 |
0.08 |
n |
174 |
173 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of November 2014 to November 2017.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified according to Regulation (EC) No. 1272/2008
- Conclusions:
- Based on the results of an in vitro skin irritation study, performed according to OECD guideline 439 and GLP principles, Tetrahydro-6propyl-2H-pyran-2-one (delta octalactone) is determined to be non-irritant to the skin (mean tissue viability of 62%). The test item is not classified according to GHS and according to Regulation (EC) No. 1272/2008.
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