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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-101-8 | CAS number: 111497-86-0
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 December 2005 - 01 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- EC Number:
- 601-101-8
- Cas Number:
- 111497-86-0
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- Details on test material:
- - Name of test material: Amine Synergist - Physical state: Pale yellow liquid- Storage condition of test material: Stored at room temperature in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CrI:CD-1 (ICR)BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River (UK) Limited, Margate, Kent- Age at study initiation: 5-8 wk- Weight at study initiation: 21-29 g- Assigned to test groups randomly: Yes- Housing: Seven animals/cage housed in solid-floor polypropylene cages with wood-flake bedding- Diet (e.g. ad libitum): Food (Certified Rat and Mouse Diet Code 5LF2, IPS Ltd., London, UK)- Water (e.g. ad libitum): Drinking water, ad libitum- Acclimation period: 7 d, ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 19-25 °C- Humidity (%): 30-70 %- Air changes (per h): 15/h- Photoperiod (h dark / h light): 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Arachis oil- Concentration of test material in vehicle: 5, 25, 50 and 100 mg/mL- Amount of vehicle: 10 mL/kg- Lot/batch no. (if required): SN365
- Duration of treatment / exposure:
- 24 or 48 hours
- Frequency of treatment:
- Single administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:250, 500 and 1,000 mg/kg bwBasis:nominal conc.
- No. of animals per sex per dose:
- Test and vehicle (control) group: Seven male micePositive control: Five male mice
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - Positive control: Cyclophosphamide- Route of administration: Oral- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow smears
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Doses were selected based on the results of range-finding toxicity test in which 1,000 mg/kg was observed to be the maximum tolerated dose.DETAILS OF SLIDE PREPARATION: Immediately following termination (i.e. 24 or 48 h following dosing), both femurs were dissected from each animal, aspirated with foetal calf serum and bone marrow smears prepared following centrifugation and re-suspension. The smears were air-dried, fixed in absolute methanol, stained in May-Griinwald/Giemsa, allowed to air-dry and cover-slipped using mounting medium.METHOD OF ANALYSIS: Stained bone marrow smears were coded and examined blind using light microscopy at x1000 magnification. Incidence of micronucleated cells per 2000 polychromatic erythrocytes (PCE-blue stained immature cells) per animal; number of nonnochromatic erythrocytes (NCE-pink stained mature cells) associated with 1000 erythrocytes and NCE/PCE were recorded.
- Evaluation criteria:
- A positive mutagenic response would be demonstrated when a statistically significant, dose-responsive, toxicologically relevant increase in the number of micronucleated polychromatic erythrocytes was observed for either the 24 or 48 hours kill times when compared to their corresponding control group.If these criteria were not fulfilled, then the test material was considered to be non-genotoxic under the conditions of the test.A positive response for bone marrow toxicity would be demonstrated when the dose group mean polychromatic to nonnochromatic ratio was shown to be statistically significantly lower than the concurrent vehicle control group.
- Statistics:
- All data were statistically analysed using appropriate statistical methods as recommended by theUKEMS Sub-committee on Guidelines for Mutagenicity Testing Report, Part III (1989). The data was analysed following a (x + 1)^1/2 transformation using Student's t-test (two tailed) and any significant results were confirmed using the one way analysis of variance.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- at 2,000 mg/kg in range-finding test
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY- Dose range: 1,000 and 2,000 mg/kg- Mortality: 2/2 animals died at 2,000 mg/kg, no mortality at 1,000 mg/kg- Clinical signs of toxicity in test animals: Hunched posture, ptosis, ataxia, lethargy, pilo-erection and decreased respiratory rate.RESULTS OF DEFINITIVE STUDY- Induction of micronuclei (for Micronucleus assay): Increases in the frequency of micronucleated PCEs was statistically non-significant.- Ratio of PCE/NCE (for Micronucleus assay): Decreases in the PCE/NCE ratio in the 24 or 48 hours test material groups was statistically non-significant.
Any other information on results incl. tables
Table 1: Micronucleus Test - Summary of Group Mean Data
Treatment Group | Number of PCE with Micronuclei per 2000 PCE | PCE/NCE Ratio | ||
Group Mean | SD | Group Mean | SD | |
Vehicle Control (Arachis oil) 10 mL/kg 48-h Sampling Time | 0.6 | 0.8 | 0.88 | 0.19 |
Vehicle Control (Arachis oil) 10 mL/kg 24-h Sampling Time | 1 | 1 | 0.72 | 0.25 |
Positive Control (Cyclophosphamide) 50 mg/kg 24-h Sampling Time | 49.0** | 19.2 | 1.26 | 0.31 |
Amine Synergist 1000 mg/kg 48-h Sampling Time | 0.6 | 1.1 | 0.8 | 0.32 |
Amine Synergist 1000 mg/kg 24-h Sampling Time | 1.1 | 0.9 | 0.95 | 0.24 |
Amine Synergist 500 mg/kg 24-h Sampling Time | 1.3 | 1.5 | 0.85 | 0.28 |
Amine Synergist 250 mg/kg 24-h Sampling Time | 0.3 | 0.5 | 0.69 | 0.19 |
PCE = Polychromatic erythrocytes
NCE = Normochromatic erythrocytes
SD = Standard deviation
** = P < 0.01
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the test substance was negative in the mouse micronucleus test.
- Executive summary:
A study was conducted to assess the potential of the test substance to produce damage to chromosomes or aneuploidy when administered to mice according to OECD Guideline 474 and EU Method B.12.
The test substance (250, 500 and 1,000 mg/kg bw) was administered intraperitoneally to seven male mice. Animals were killed 24 or 48 h later, the bone marrow extracted and smear preparations made and stained. Polychromatic (PCE) and normochromatic (NCE) erythrocytes were scored for the presence of micronuclei. Further groups of mice were given a single intraperitoneal dose of arachis oil (7 mice) or dosed orally with cyclophosphamide (5 mice), to serve as vehicle and positive controls, respectively.
There were no premature deaths seen in any of the dose groups. Clinical signs (hunched posture and ptosis) were observed in animals dosed with the test substance at and above 500 mg/kg bw in both the 24 and 48 h test groups. No statistically significant decreases in the PCE/NCE ratio were observed in the 24 or 48 h test material dose groups when compared to their concurrent control groups. However, the observation of clinical signs was taken to indicate that systemic absorption had occurred and exposure to the bone marrow achieved. There was no evidence of a significant increase in the incidence of micronucleated polychromatic erythrocytes in animals dosed with the test material when compared to the concurrent vehicle control groups. The positive control group showed a marked increase in the incidence of micronucleated polychromatic erythrocytes hence confirming the sensitivity of the system to the known mutagenic activity of cyclophosphamide under the conditions of the test.
Under the test conditions, the test substance was negative in the mouse micronucleus test.
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.