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EC number: 243-500-6 | CAS number: 20073-51-2
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February to April 2019
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
- EC Number:
- 243-500-6
- EC Name:
- 2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol
- Cas Number:
- 20073-51-2
- Molecular formula:
- C25H46N2O5
- IUPAC Name:
- 2,6-bis({[bis(2-hydroxyethyl)amino]methyl})-4-nonylphenol
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Details of the test item provided by the Sponsor (Ref. TIDS):
Test Item Name
POLIOL MB 600
IUPAC Name
2,6-bis[[bis(2-hidroxietil)amino]metil]-4-nonil-fenol
CAS Number
20073-51-2
Molecular Formula
C25H46N2O5
Molecular Weight
454.652
Batch/Lot Number
7590
Analysed Purity
99.6%
(Refer certificate of analysis in (APPINDIX 9)
Manufactured by
Sistemas Ecologicos De Poliuretano, SL
Supplied to JRF by
Sistemas Ecologicos De Poliuretano, SL
Date of Manufacture
December 12, 2018
Date of Expiry
December 12, 2019
Appearance
Viscous Liquid, Dark yellow, slightly like formaldehyde
Other Characteristics
Specific gravity: 1085 g/L, pH: 7
As per the instruction received from the Sponsor on storage of the test item, the test item was stored :
Storage Temperature : Room Temperature
Storage Condition: Protected against moisture
Storage Container: In original container as supplied by the Sponsor
Sponsor
Storage Location
:
Test Item Control Office, JRF
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human peripheral blood lymphocites cultured in vitro
- Details on mammalian cell type (if applicable):
- human peripheral blood lymphocites cultured in vitro
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Absence of Metabolic Activation
60 µL of 0.5 mg/mL of Mitomycin-C added to 940 µL of sterile distilled water. 80 µL of this was used for 8 mL of treatment medium (0.3 µg/mL).
Presence of Metabolic Activation
20.0 mg of Cyclophosphamide dissolved in 5 mL of sterile distilled water (Phase I) to obtain required concentration (Stock - 4 mg/mL). 80 µL of this stock was used for 8 mL of treatment medium (40 µg/mL).
- Test concentrations with justification for top dose:
- 5 ug/mL, 10 ug/mL, 20 ug/mL, 40ug/mL, 60ug/mL, 80 ug/mL.
No relevant influence of the test item on pH value or osmolality was observed in the absence (Phase I and II) and the presence of metabolic activation (Phase I). Precipitation was not observed up to 80 µg/mL, in the absence and 125 µg/mL, in the presence of the metabolic activation at 0 and 4 hour after incubation in Phase I and 24 hour in Phase II in absence of metabolic activation. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- The test system used for the in vitro chromosomal aberration test was human peripheral blood lymphocytes, as recommended by the OECD and other regulatory authorities. The selection criteria for volunteers were as per JRF standard operating procedure. Blood was drawn from healthy, 26 and 25 years old female volunteer for the cytotoxicity test and main study, respectively, by venous puncture using heparinised syringe (Heparin obtained from Biological E. Limited, Hyderabad). The donor selected were non-smoker, non-alcoholic, free from drug, radiation and chemical exposure. A trained medical laboratory technician collected the blood by vein puncture using a 21 G needle attached to a 50 mL disposable syringe.
- Evaluation criteria:
- Chromosomal Aberrations
Mitotic index was scored for all the six test concentrations and based on mitotic index; three suitable concentrations were selected for assessment of chromosomal aberrations. All slides, including those of positive and negative controls, were independently coded prior to microscopic analysis for chromosomal aberrations. 300 well spread metaphases (150/replicate) were scored for the structural chromosomal aberrations per concentration and controls.
Only cells containing 46 ± 2 chromosomes were examined for structural changes. A smaller number (e.g. 50 metaphases per slide) of metaphases were analyzed in slides showing higher frequency (more than 20%) of aberrant cells. Gaps, breaks, fragments, exchanges, multiple aberration and deletions were recorded with their numbers and frequencies for all the treated and control cultures separately. In addition, 100 metaphases/replicate were examined for polyploidy.
The number of metaphases with only gap were recorded but not considered to calculate total aberrations and percent aberrant cells.
- Statistics:
- Gaps and polyploidy were not included in the calculation of total aberration frequency. Data on percent aberrant cells and polyploidy were subjected to Shapiro-Wilk’s test for normality and Bartlett’s test to assess homogeneity of variance before conducting Analysis of Variance (ANOVA) and Dunnett’s t-test (Gad and Weil, 1994). Where the data did not meet suitable homogeneity of variance, Student's t-test was performed to determine the level of significance between negative control, three selected test concentrations (selected based on the mitotic index data) and positive controls. Where the data show significance in Shapiro-Wilk’s test, Chi-square test for trend analysis was performed to determine the significance between negative controls, three selected test concentrations and positive controls.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human peripheral blood lymphocites cultured in vitro
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The substance is not mutagenic on the tested conditions
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- From results of this study, it is concluded that POLIOL MB 600 did not show any potential to induce chromosomal aberration, either in the absence or presence of the metabolic activation under the present experimental conditions and is considered to be negative for clastogenicity.
- Executive summary:
In a mammalian chromosomal aberration test, human peripheral blood
lymphocytes, cultured in vitro, were exposed to POLIOL MB 600 at different concentrations, in the absence and presence of the metabolic activation (2% v/v S9 mix).
Based on results of preliminary solubility and cytotoxicity tests, 80 µg/mL, in the absence of the
metabolic activation in Phase I and II and 125 µg/mL in the presence of the metabolic activation (2% v/v
S9 mix) were selected as the highest test concentration for the main study. POLIOL MB 600 was tested in
two phases, with (2% v/v S9 mix) and without metabolic activation (4h exposure) and second phase (24h
exposure) without metabolic activation. Hence, human peripheral blood lymphocyte cultures were
exposed to POLIOL MB 600 at six concentrations (two cultures/concentration in each experiment) from 5
to 80 µg/mL, in the absence in Phase I and II and 3.91 to 125 µg/mL in the presence of the metabolic
activation.
POLIOL MB 600 did not induce any statistically significant or biologically relevant increase in the
number of percent aberrant cells, in the absence and presence of S9-mix for the short term (phase-I, 4
hours) and in the absence of S9, long term (phase-II, 24 hours) exposure period. No effect of POLIOL
MB 600 on the number of polypoid cells was observed, in the absence (phase I and phase II) and presence
of S9-mix (phase I) in both phases. All negative controls were comparable to historical control limits and
positive controls showed an increase in the incidence of cells with chromosomal aberrations.
All criteria for a valid study were met, as described in the study plan. From results of this study, it is
concluded that POLIOL MB 600 did not show any potential to induce chromosomal aberrations either in
the absence or presence of the metabolic activation system, under the described experimental conditions
and is considered to be negative for clastogenicity.
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