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EC number: 816-146-0 | CAS number: 1016788-34-3
- 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:
- March 2012
- Reliability:
- 1 (reliable without restriction)
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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Official journal of the European union dated august, 24'h, 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM protocol
- Version / remarks:
- November 5th, 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[(2-acetamidoacetyl)amino]propanoic acid
- EC Number:
- 816-146-0
- Cas Number:
- 1016788-34-3
- Molecular formula:
- C7H12N2O4
- IUPAC Name:
- 3-[(2-acetamidoacetyl)amino]propanoic acid
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Details on test system:
- Human reconstructed epidermis, SkinEthic model 0.5 cm', maintained according to the supplier instructions.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Series definition:
16 microL of the test item diluted at 5 %, as well as the reference items, are tested on three epidermis.
Test protocol:
16 microL ± 0.5 microL of the test item have been deposited with a positive displacement micropipette on the surface of the epidermis and a 7.5 mm diameter nylon mesh is gently applied on the surface of the
epidermis with tweezers.
16 microL ± 0.5 microL of reference item are deposited with a micropipette positive displacement on the surface of the tissue. A 7.5 mm diameter nylon mesh is gently applied on the surface of the epidermis in with
tweezers. - Duration of treatment / exposure:
- The epidermis are incubated in 0.3 ml of maintenance medium (24 wells plate) at room temperature for 42 minutes ± 1 minute.
- Duration of post-treatment incubation (if applicable):
- Nylon meshes are removed and the epidermis are rinsed with 25 ml of PBS by epidemlis (25 times 1 ml using a dispenser). The residual PBS is eliminated on absorbent paper. If necessary the epidermis
can be gently swept with a cotton tip. The epidermis are incubated in 2 ml of growth medium in 6 wells plate at 37 °C, 5% CO, for 42 hours ± 1 hour.
All epidermis (living and dead) are incubated in 0.3 ml of maintenance medium at 1 mg/ml MIT in 24 well plate.
After 3 hours ± 5 minutes incubation at 37°C, 5% CO2 outside of inserts is rinsed with1I to 2 ml of PBS.
Extraction is performed by placing the epidermis into wells filled with 0.8 ml of isopropanol and covered with 0.7 ml isopropanol for 2 hours ± 5 minutes under gentle agitation protected from light.
The absorbance is measured in triplicat on 200 microL extract in 96-wells plates. Absorbances are measured at 540 nm against a blank consisting with isopropanol. - Number of replicates:
- 3 replicates for test item, 3 replicates for positive control and 3 replicates for negative control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue Viability (%)
- Value:
- ca. 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
ASSESMENT OF VIABILITY | CONCLUSION | |||||
Abs. | mean | Standard deviation | Viability % | |||
Negative control PBS |
Ep.1 Ep.2 Ep.3 |
1.904 1.894 1.892 1.951 1.946 1.905 1.778 2.124 1.777 |
1.908 | 0.103 | 100% | Non Irritant |
Positive control SDS 5% |
Ep.1 Ep.2 Ep.3 |
0.020 0.020 0.018 0.021 0.021 0.019 0.022 0.022 0.020 |
0.020 |
0.001 |
1.1% |
Irritant |
Test item |
Ep.1 Ep.2 Ep.3 |
2.160 2.148 2.108 1.862 1.907 1.971 1.707 1.680 1.620 |
1.907 |
0.207 |
100% |
Non Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation EC No. 127212008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified.
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