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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
Endpoint summary
Administrative data
Description of key information
In a GLP compliant OECD TG 431 study, the test item was investigated for skin corrosive properties using the three-dimensional human skin model EpiDermTM, comprising a reconstructed epidermis with a functional stratum corneum. Based on the results, the test item is considered to be not corrosive to skin. In a follow-up study according to the OECD 439 study protocol, C16-18-(even numbered)alkylamine acetates was evaluated as being a skin irritant. This result is in line with data for the corresponding primary alkylamine C16-18-(even numbered)-alkylamines.
No study is available with regard to eye irritation. However, based on data from analogous primary alkylamines a high irritation potential to eyes has to be assumed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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 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
- 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
- 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.
- 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)
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The registration substance was tested for skin irritation/corrosion in the in vitro human skin model tests according to OECD TG 431 and 439. Whereas no indication for skin corrosion was revealed, the test item demonstrated skin irritative properties. This is in line with experimental data from analogues primary alkylamines. With regard to eye irritation, no test data on the registration substance is available but data from analogous primary alkylamines indicate that it should be regarded as highly irritating to eyes.
Justification for selection of skin irritation / corrosion endpoint:
Guideline study according to GLP
Justification for selection of eye irritation endpoint:
No study for eye irritation is available for the registration substance. However, based on data from analoguous primary alkylamines a severe eye irritation potential has to be assumed.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on guideline conform testing, the registration substance has to be considered as a skin irritant and is therefore classified as "skin irritant category 2 with H315 - causes skin irritation" according to GHS-CLP (equivalent to EU Risk-Phrase R38 - irritating to skin according to DSD).
With regard to eye irritation, read-across to analogue primary alkylamines indicate that the registration substance is highly irritating to eyes and thus should be classified as causing serious damage to eyes (category 1, H318) according to GHS-CLP (equivalent to EU Risk-Phrase R41 - risk of serious damage to eyes).
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.
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