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EC number: 800-526-8 | CAS number: 1273322-45-4
- 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:
- 2012-05-09 to 2012-05-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- C16-18-(even numbered)-alkylamines acetates
- EC Number:
- 800-526-8
- Cas Number:
- 1273322-45-4
- Molecular formula:
- R-NH2xHOOCCH3 R = alkyl, mainly C16-18-(even numbered)
- IUPAC Name:
- C16-18-(even numbered)-alkylamines acetates
- Details on test material:
- Name: C16-18-(even numbered)-alkylamines acetates
CAS No: 1273322-45-4
Physical State at RT: solid
Colour: white-yellow
pH: 5.7 (1% a.i. in water)
Melting Point: 70-72 °C
Storage Conditions: at room temperature
Constituent 1
In vitro test system
- Test system:
- human skin model
- Amount/concentration applied:
- solids: 25 µL DPBS + 25 mg
- Duration of treatment / exposure:
- 60 +/- 1 minutes
- Duration of post-treatment incubation (if applicable):
- 42 +/- 4 h
- Number of replicates:
- 3
Test animals
- Species:
- other: EpiDerm reconstructed human epidermis model (MatTek Corp.)
- Details on test animals or test system and environmental conditions:
- organotypic reconstructed three-dimensional model of the human epidermis
Test system
- Type of coverage:
- other: direct application
- Controls:
- other: three tissues for negative control (30µL DPBS) and positive control (30µL 5% SDS)
- Details on study design:
- 3 replicate tissues are dosed with the test item, the negative control (DPBS) and the positive control (5% SDS), respectively. The tissues are incubated for 35 +/-1 minutes in a humidified incubator (37+/- 1 °C, 5 +/- 1% CO2, 95% RH) and further 25 minutes at room temperature. Then the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 24 +- 2 h and, after medium renewal, for further 18 +/- 2 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: mean relative tissue viability
- Value:
- > 50
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean tissue viability of the negative control tissues. Time point: 60 min treatment 42 h post-incubation. Remarks: non-irritant; EU CLP and UN GHS: No Category. (migrated information)
- Irritation / corrosion parameter:
- other: other: mean relative tissue viability
- Value:
- <= 50
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean tissue viability of the negative control tissues. Time point: 60 min treatment 42 h post-incubation. Remarks: irritant; EU CLP and UN GHS Category 2. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant
- Remarks:
- Criteria used for interpretation of results: other: OECD 439
- Conclusions:
- The test item is classified as "irritant" (Category 2).
- Executive summary:
In the in vitro skin irritation test using the EpiDerm human epidermis model 25 mg test item + 25 µL DPBS were applied topically for 60 minutes.
After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.
The mean relative tissue viability (% negative control) was <= 50%.
The test item is therefore classified as "irritant" (EU CLP and UN GHS: Category 2).
The test item showed irritant effects. The mean relative tissue viability (% negative control) was< 50% (30.6%) after 60 min treatment and 42 h post incubation. The test item could not be applied evenly on the tissue surface due to its waxy/jellylike consistence which formed clots after application. Therefore, the three tissues treated identically with the test item showed varying viabilities, whereas two replicates showed consistent values (17.2% and 22.0% versus 52.6%) indicating irritant potential. The standard deviation between the three tissues was therefore exceeding the 18% cut-off (19.2%). This is accepted due to the properties of the test item as described above.
This study is classified as acceptable:
Mean OD550 of the three negative control tissues is >=1 and <=2.5.
Mean relative tissue viability of the three positive control tissues is <= 20%.
Standard deviation (SD) of relative tissue viablity obtained from each three concurrently tested control tissues is < 18%.
This study satisfies the requirement for Test Guideline OECD 439 for in vitro skin irritation.
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