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Diss Factsheets
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EC number: 627-580-3 | CAS number: 53617-35-9
- 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:
- 27 - 29 Oct 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted Jul 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
Test material
- Reference substance name:
- 4-(piperidin-4-yl)morpholine
- EC Number:
- 627-580-3
- Cas Number:
- 53617-35-9
- Molecular formula:
- C9H18N2O
- IUPAC Name:
- 4-(piperidin-4-yl)morpholine
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Source strain:
- other: EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 23300 (EpiDerm™ Tissues); 102215ZSA (Assay medium); 21675 (EpiDerm™ freeze killed Tissues)
- Delivery date: 27 Oct 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Each tissue was rinsed under a constant soft stream of Dulbecco`s Phosphate-Buffered Saline (DPBS). Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 562 nm
NUMBER OF REPLICATE TISSUES: Duplicates of each 2 independent experiments
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
The relative mean viability was calculated in the following way:
Relative mean viability (%) = (mean OD562 of the test substance)/(mean OD562 of negative control) x 100 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
POSITIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration (if solution): 8.0 N - Duration of treatment / exposure:
- 3 and 60 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of the test item
- Run / experiment:
- 3 min
- Value:
- 85.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of the test item
- Run / experiment:
- 60 min
- Value:
- 10.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: Yes; an additional procedure using freeze-killed tissues was performed in parallel.
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: OD values for the negative control are ≥ 0.8 and ≤ 2.8 for every exposure time
- Acceptance criteria met for positive control: Mean viability of the tissue replicates exposed for 1 hour with the positive control (8N KOH), expressed as % of the negative control, should be < 15%
- Acceptance criteria met for variability between replicate measurements: In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be ≤ 30%
Any other information on results incl. tables
Table 2: Mean OD562 and viabilities for the negative control, positive control and test item
Tissue | Exposure Period | Mean OD562 of individual tissues | Mean OD562 of duplicate tissues | Standard Deviation | Coefficient of Variation (%) | Relative Mean Viability (%) |
Negative Control | 3 min | 1.975 | 1.959 | 0.023 | 1.2 | 100 * |
1.943 | ||||||
60 min | 2.162 | 2.134 | 0.040 | 1.9 | ||
2.106 | ||||||
Positive Control | 3 min | 0.046 | 0.076 | 0.042 | N/A | 3.9 |
0.106 | ||||||
60 min | 0.060 | 0.056 | 0.006 | N/A | 2.6 | |
0.052 | ||||||
Test Item | 3 min | 1.724 | 1.670 | 0.077 | 4.6 | 85.2 |
1.615 | ||||||
60 min | 0.186 | 0.226 | 0.057 | N/A | 10.6 | |
0.266 |
* The mean % viability of the negative control tissue is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- other: positive according to OECD 431 and according to CLP/EU GHS criteria
- Conclusions:
- CLP: Skin corrosive Cat 1, H314
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