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EC number: 700-923-5 | CAS number: 10305-39-2
- 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:
- 02 July 2019 - 05 July 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-(heptyloxy)propane-1,2-diol
- Cas Number:
- 10305-39-2
- Molecular formula:
- C10H22O3
- IUPAC Name:
- 3-(heptyloxy)propane-1,2-diol
- Test material form:
- liquid
- Details on test material:
- Physical description: Clear to yellowish liquid
Storage conditions: Room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE / Human Epidermis (RHE/S/17)
- Tissue batch number(s): 19-RHE-113
- Surface: 0.5 cm2
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure to the test item: room temperature
- Temperature of incubations(°C): 37%
- Humidity(%): 95%
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: tissues were washed with phosphate buffered saline (1 washing step)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE:
- Incubation time: 3 hours +/- 5 minutes at 37 °C
- Measurement method: Visual assessment
- MTT concentration: 0.3 mg/mL in SkinEthic maintenance medium
NUMBER OF REPLICATE TISSUES: 3 tissues per test item, negative and positive controls.
PREDICTION MODEL / DECISION CRITERIA (see table 1)
The irritation potential of test item is predicted by the mean tissue viability of tissues exposed to the test item
- The test item is considered to be Category I or 2 if the mean relative viability after 42 minutes exposure and 42 hours post incubation is lower than or equal to 50% of the negative control.
- The test item is considered to be non irritant to skin, if the mean relative viability after 42 minutes exposure and 42 hours post incubation is higher than 50% of the negative control.
ACCEPTABILITY CRITERIA
- Blank (extraction solvent): The mean absorbances must be lower than 0.1.
- Negative control: The mean Absorbances must be higher than or equal to 0.8 and lower than or equal to 3.0. The standard deviation of the measured viabilities must be lower than or equal to 18%.
- Positive control: The viability percentage for the positive control must be lower than 40%. The standard deviation of the measured viabilities must be lower than or equal to 18%.
- Test item: The standard deviation measured viabilities must be lower or equal to 18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 +/- 0.5 µL (a 7.5 mm diameter (0.5 cm2) nylon mesh was gently applied after application of the substance on the surface of the epidermis)
NEGATIVE CONTROL
- Amount applied: 16 +/- 0.5 µL (a 7.5 mm diameter nylon mesh was gently applied after application of the substance on the surface of the epidermis)
POSITIVE CONTROL
- Amount applied: 16 +/- 0.5 µL (a 7.5 mm diameter nylon mesh was gently applied after application of the substance on the surface of the epidermis) - Duration of treatment / exposure:
- 42 +/- 1 minute
- Duration of post-treatment incubation (if applicable):
- 42 hours; + 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:
- 66.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- Mean tissue viability(%): 1.8
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Validity criteria met for the blank control: Yes, the mean absorbances was 0.036.
- Acceptance criteria met for negative control: Yes, the absolute mean absorbanceof the negative control tissues was between 1.552 and 1.895 and the SD of the viability was 10.2%
- Acceptance criteria met for positive control: Yes, the mean relative tissue viability was 1.8% and the SD of the viability was 0.6%.
- Acceptance criteria met for variability between replicate measurements: Yes, the variability between tissue treated with the test item was 5%.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- According to Regulation (EC) No. 1272/200
- Conclusions:
- In an in vitro skin irritation test performed according to OECD guideline 439 and in accordance with GLP principles the substance showed to be a non-irritant (mean tissue viability of 66.8%).
- Executive summary:
An in vitro skin irritation test using a human skin model was performed according to OECD TG 439 and in accordance with GLP principles. The test substance (16 +/- 0.5 µL ) was applied and covered with a nylon mesh. After 42 minutes, the substance was removed and cells were cultured for 42 hours. The viability of the cells was tested by reduction of MTT. Survival of unexposed skin was set at 100%, the positive control had a mean cell viability of 1.8% and the test substance showed a mean cell viability of 66.8%. Since the mean tissue viability for the test item was above 50% after treatment the test item is considered to be a non-irritant. In conclusion, Saskine 70 is a non-irritant in the in vitro skin irritation test under the experimental conditions described and should not be classified according to Regulation (EC) No. 1272/2008 and its amendments.
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