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Diss Factsheets
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EC number: 205-755-1 | CAS number: 150-25-4
- 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:
- 16 January 2017 - 27 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 20 July 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)glycine
- EC Number:
- 205-755-1
- EC Name:
- N,N-bis(2-hydroxyethyl)glycine
- Cas Number:
- 150-25-4
- Molecular formula:
- C6H13NO4
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)glycine
- Reference substance name:
- N-(2-hydroxyethyl)ethylenediaminetriacetic acid
- EC Number:
- 205-759-3
- EC Name:
- N-(2-hydroxyethyl)ethylenediaminetriacetic acid
- Cas Number:
- 150-39-0
- Molecular formula:
- C10H18N2O7
- IUPAC Name:
- N-{2-[bis(carboxymethyl)amino]ethyl}-N-(2-hydroxyethyl)glycine
- Reference substance name:
- Not specified
- IUPAC Name:
- Not specified
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- solid: crystalline
- Details on test material:
- Appearance: white crystalline powder
Storage conditions: at room temperature protected from light
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- Stable at higher temperatures: Yes, with a maximum temperature of 40 °C and for a maximum duration of 2 days.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- skin obtained from plastic surgery from multiple donors
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 22 hours at 37°C
ENVIRONMENTAL CONDITIONS
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 36.0-37.1 °C
- Humidity (%): 64-87
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1, with phosphate buffered saline
- Observable damage in the tissue due to washing: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader.
- Wavelength: 570 nm
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is = 50% of the mean viability of the negative controls.
- The test substance is considered to be non-irritant to skin if the relative mean tissue viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours of post incubation is > 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- Amount/concentration applied:
- TEST ITEM:
18.9 to 32.0 mg on skin moistened with 5 µl Milli-Q water
NEGATIVE CONTOL:
- Amount applied: 25 µl Phosphate buffered saline
POSITIVE CONTROL
- Amount applied: 25 µl
- Concentration: 5% (aq) Sodium dodecyl sulphate
- Re-spread after 7 minutes contact time - Duration of treatment / exposure:
- 15 ±0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Test system
- Details on study design:
- TEST SITE
- EPISKIN Standard Model (TM) (EPISKIN-SM (TM), 0.38 cm^2, Lot no.: 17-EKIN-008).This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded in 12-well plates on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days , which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
SCORING SYSTEM:
- Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.
- The test item was checked for possible direct MTT reduction and colour interference
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 replicates
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- (100%)
- Positive controls validity:
- valid
- Remarks:
- (22%)
- Remarks on result:
- other: SD of test item: 2.6%
- Other effects / acceptance of results:
- - The positive control had a mean cell viability of 22% after 15 minutes of exposure. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly.
- Since all acceptability criteria are met, the study is considered to be valid.
Any other information on results incl. tables
The test item was checked for colour interference in aqueous conditions and possible direct MTT reduction by adding the test item to MTT medium. No colour change was observed, therefore it was concluded that the test substance did not interact with MTT.
The mean optical densities at 570 nm (OD570) were:
Negative control: 0.835 ±0.033
Test item: 0.784 ±0.021
Positive control: 0.186 ±0.043
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- (CLP criteria also not met)
- Conclusions:
- An in vitro skin irritation test with Bicin was conducted according to OECD 439 guideline and GLP principles. It is concluded that this test is valid and that the substance is not irritating in the in vitro skin irritation test according to the GHS and CLP criteria, under the experimental conditions described in this report.
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