Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-995-6 | CAS number: -
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-03-25 until 2013-09-30
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 21773-2008 Chemicals
- GLP compliance:
- yes
- Type of assay:
- other: mammalian bone marrow cells
Test material
- Reference substance name:
- Amides, C16-18 and C18-unsatd., N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-,ethoxylated, lactates (salts)
- Cas Number:
- 1434133-00-2
- Molecular formula:
- C47H96N3O5+ C3H5O3-
- IUPAC Name:
- Amides, C16-18 and C18-unsatd., N,N'-[[(2-hydroxyethyl)imino]di-2,1-ethanediyl]bis-,ethoxylated, lactates (salts)
- Test material form:
- solid: bulk
- Details on test material:
- Batch ST02697671
Constituent 1
- Specific details on test material used for the study:
- Lot: ST02697671
purity: 86.8%
Test animals
- Species:
- mouse
- Strain:
- other: KM mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Changsa Tianqin biotechnology Ltd.
- Age at study initiation:
- Weight at study initiation:
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing: SPF barrier environment
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 54-60
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
weight 3.75 g test substance and add distilled water to 30 mL to prepare the stock solution with the concentration of 125 mg/mL for high dose group (2500 mg/kg). Then draw 4.0 mL and 8.0 mL high dose group solution, add distilled water to 16 mL, to prepare stock solution for low dose group (625 mg/kg) and medium dose group (1259 mg/kg) animals respectively. The concentrations were 31.2, 62.5 mg/mL respectively. - Duration of treatment / exposure:
- The test substance was administered to mice at a volume of 0.2 mL/10 g bw by gavage twice during the period of 24h (at the beginning and at the 24h respectively). The solvent control group was treated by the same method. The positive control group was treated with cyclophosphamid (0.2%) by celiac injection at a volume of 0.15 ml/10 g bw.
- Frequency of treatment:
- twice, at 0 and 24 hours
- Post exposure period:
- 18 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 500 mg/kg bw (total dose)
- Dose / conc.:
- 1 250 mg/kg bw (total dose)
- Dose / conc.:
- 625 mg/kg bw (total dose)
- Dose / conc.:
- 30 mg/kg bw (total dose)
- Remarks:
- positive control, Cyclophosphamide
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: celiac injection
- Doses / concentrations: 30m/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow cells
- Details of tissue and slide preparation:
- Bone marrow cells were harvested from the sternum and cell smears were prepared and stained according to conventional procedures. The region of cell-completely, well-distributed and well-colored up was selected and examined under a microscope. 2000 polychromatic erythrocytes per animal were scored for the incidence of micronclei. The ratio of PCEs to NCEs was also determined for each animal by counting a total of 200 erythrocytes, as an indication of cytotoxicity to the bone marrow cells.
- Statistics:
- The micronucleated PCE ratios for all dose-groups and solvent control group were analyzed using the poisson distribution and that of positive control group was handled with Gaussion distribution. Each sex was analyzed respectively. The parameters and data were analyzed statistically by SPSS 13.0.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No clinical signs were observed in any test animal. And no death occurred in any test animal during the period of the test.
The incidence of MNPCE in each treatment group were summarized Table 1. The incidence of MNPCE in solventr control groups were 1.4% and 1.6% for female and male mice respectively. The incidence of MNPCE were 1.0%, 1.7%, 1.5% for female mice and 0.8%, 1.3%, 0.9% for male mice in low, medium and high dose groups respectively, there were no significant differences compared with the solvent control (p>0.05). The incidence of MNPCE in positive control group were 24.9% and 22.6% for female and male mice respectively, there were significant differences compared with the solvent control group (p<0.01)
The result indicated, that the test substance could not increase the micronuclear rates of KM mice obviously.
Applicant's summary and conclusion
- Conclusions:
- It was concluded that the test substance was negative in the mammalian erythrocyte micronucleus test in vivo.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.