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EC number: 252-471-9 | CAS number: 35265-04-4
- 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
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:
- This assay was performed to complain to the Chinese regulation on chemical substances
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusion.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Remarks:
- deviations to study plan but not to guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Remarks:
- idem above
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-[(1-methylpropyl)amino]ethanol
- EC Number:
- 252-471-9
- EC Name:
- 2-[(1-methylpropyl)amino]ethanol
- Cas Number:
- 35265-04-4
- Molecular formula:
- C6H15NO
- IUPAC Name:
- 2-[(butan-2-yl)amino]ethan-1-ol
- Details on test material:
- - Name of test material 2-[(1-methylpropyl)amino]ethanol
- Chemical name: sec-butyl aminoethanol
- Physical state: colorless to yellow liquid
- Analytical purity: 99.76%
- Lot/batch No.: A2053H010101
- Expiration date of the lot/batch: January 2013
- Storage conditions of test material: at room temperature and protected from humidity.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Charles River Laboratories France, L'Arbresle, France
- Age at study initiation: on the day of treatment, the animals of the main test were approximately 6 weeks old
- Weight at study initiation: at the beginning of treatment the mean body weight was 156.8 g for males (ranging from 144 g to 167 g) and 142 g
for females (ranging from 131 g to 164 g)
- Housing: polycarbonate cages
- Diet (e.g. ad libitum): SSNIFF R/M-H pelleted maintenance diet
- Water (e.g. ad libitum): tap water (filtered with a 0.22 µm filter)
- Acclimation period: 6 days before the day of treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 12 cycles/hour of filtered non-recycled fresh air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (07:00 - 19:00).
IN-LIFE DATES: From: 26 May 2011 To: 30 June 2011.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: drinking water
- Concentration of test material in vehicle: 10 to 40 mg/mL.
- Justification for choice of solvent/vehicle: soluble
- Amount of vehicle (if gavage or dermal): 10 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was administered as a solution in the vehicle. The dosage forms were prepared by the CIT pharmacy and no aluminium equipment
was used for the preparation of the dosage forms.
The formulations were stirred for a minimum of 30 minutes in order to ensure the solubilisation of the test item in the vehicle.
The dosage forms are known to be stable for 11 days at room temperature and protected from light (CIT/Study No. 37512 AHS).
For the two preliminary tests, the dosage forms were prepared within the 4 hours before use and kept at room temperature and protected from
light until use.
For the main test, the dosage forms were prepared in the same manner by the CIT Pharmacy 1 day before the first treatment, stored at room temperature and protected from light. - Duration of treatment / exposure:
- Two treatments separated by 24 hours.
- Frequency of treatment:
- One treatment per day.
- Post exposure period:
- 24 hours after last treatment.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 200 and 400 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females for the 100 and 200 mg/kg/day target dose-levels.
8 males and 8 females for the 400 mg/kg/day target dose-level. - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 10 mL/kg.
Examinations
- Tissues and cell types examined:
- Bone marrow: polychromatic (PE) and normochromatic (NE) erythrocytes.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
Since toxic effects were observed in the preliminary toxicity tests, the choice of the top dose-level was based on the level of toxicity, such that a higher dose-level was expected to induce lethality.
SAMPLING TIMES:
At sacrifice, 24h after last treatment.
DETAILS OF SLIDE PREPARATION:
After sacrifice, the femurs were removed and bone marrow was flushed and suspended in fetal calf serum. The separation of anucleated erythrocytic
cells from other myeloic cells was carried using a cellulose column. This elution step enables the production of slides containing only polychromatic
and normochromatic erythrocytes without any nucleated cells or mast cell granules. After centrifugation of the eluate containing the cells, the
supernatant was removed and the cells in the sediment were resuspended. A drop of this cell suspension was placed and spread on a slide. At least
two slides were prepared for each animal. The slides were air-dried and stained with Giemsa and then coded for "blind" scoring.
METHOD OF ANALYSIS:
For each animal, the number of the Micronucleated Polychromatic Erythrocytes (MPE) was counted in 2000 Polychromatic Erythrocytes; the
Polychromatic (PE) and Normochromatic (NE) Erythrocyte ratio was established by scoring a total of 1000 Erythrocytes (PE + NE). - Evaluation criteria:
- For a result to be considered positive, there must be: a statistically significant increase in the frequency of MPE when compared to the vehicle control group. Reference to historical data or other considerations of biological relevance may be taken into account in the evaluation of data obtained.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY TOXICITY TEST (Table 1)
In order to select the top dose-level for the cytogenetic study, 600 mg/kg/day were administered twice, to three males and three females. The interval between each administration was 24 hours. One male was found dead 22h after the second treatment. Loud breathing and breathing difficulties were noted prior to its death. Loud breathing was also noted in another male before the second treatment up until sacrifice.
One female showed breathing difficulties and/or a loud breathing 5 hours after the second treatment and up until sacrifice. Since mortality occurred in this first preliminary test, a second preliminary assay was performed using the lower dose-level of 400 mg/kg/day. In the second preliminary test, no mortality occurred. The animals did not show any clinical signs except one female who had a loud breathing 4h30 after the second treatment only.
The top dose-level for the cytogenetic test was selected according to the criteria specified in the international guidelines; since toxic effects were observed, the choice of the top dose-level was based on the level of toxicity, such that a higher dose-level was expected to induce lethality.
Consequently, 400 mg/kg/day was selected as the top dose-level for the main test. The two other selected dose-levels were 100 and 200 mg/kg/day.
CYTOGENETIC TEST (Tables 2 to 4)
Mortality and clinical signs (Table 2)
Neither mortality nor clinical signs were observed in the animals of either sex from the vehicle and positive control groups.
Also, neither mortality nor clinical signs were observed in the animals of both sexes at any of the tested dose-levels.
Cytogenetic evaluation (Tables 3 and 4)
The mean values of MPE as well as the PE/NE ratio for the vehicle and positive controls were consistent with our historical data.Cyclophosphamide induced a highly significant increase (p < 0.001) in the frequency of MPE, indicating the sensitivity of the test system under our experimental conditions. The study was therefore considered to be valid.
The mean values of the PE/NE ratio in the groups treated with the test item were equivalent to those of the vehicle group, showing there is no evidence of test article related bone marrow toxicity.
The mean values of MPE in the groups treated with the test item (1.0, 1.1, 1.0 MPE/1000 PE for the male groups; 1.0, 1.4 and 0.6 MPE/1000 PE for the female groups at 100, 200 and 400 mg/kg bw, respectively) were equivalent to those of the vehicle control group (0.8 and 0.9 MPE/1000 PE for the males and females, respectively). There are no statistically significant increases in the frequency of MPE for the test item-treated groups when compared to the concurrent vehicle control group.
Therefore, the criteria for a positive response are not met, thus it is concluded that, in this study, the test item did not induce damage to the chromosomes or the mitotic apparatus of rat bone marrow cells.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test item did not induce damage to the chromosomes or the mitotic apparatus of rat bone marrow cells after two oral administrations,
at a 24-hour interval, at the dose-levels of 100, 200 and 400 mg/kg/day. - Executive summary:
The potential of the test item, 2-[(1-methylpropyl)amino]ethanol to induce damage to the chromosomes or the mitotic apparatus was evaluated in bone marrow cells of rats. The study was performed according to the international guidelines (OECD No 474 and Council Regulation (EC) No. 440/2008) and in compliance with the Principles of Good Laboratory Practice.
Two preliminary toxicity tests were performed to define the dose-levels to be used for the cytogenetic study. In the main study, three groups of five male and five female Sprague-Dawley rats received two oral treatments of 2-[(1-methylpropyl)amino]ethanolat dose-levels of 100, 200 and 400 mg/kg/day, at a 24‑hour interval. One group of five males and five females received the vehicle (drinking water treated by reverse osmosis) under the same experimental conditions, and acted as control group. One group of five males and five females received the positive control test item (cyclophosphamide) once by oral route at the dose-level of 15 mg/kg/day. The animals of the treated and vehicle control groups were killed 24 hours after the last treatment and the animals of the positive control group were killed 24 hours after the single treatment. Bone marrow smears were then prepared. For each animal, the number of the Micronucleated Polychromatic Erythrocytes (MPE) was counted in 2000 Polychromatic Erythrocytes. The Polychromatic (PE) and Normochromatic (NE) Erythrocyte ratio was established by scoring a total of 1000 Erythrocytes (PE + NE).
Neither mortality nor clinical signs were observed in the animals of either sex from the vehicle and positive control groups. Also, neither mortality nor clinical signs were observed in the animals of both sexes at any of the tested dose-levels. The mean values of MPE as well as the PE/NE ratio for the vehicle and positive controls were consistent with our historical data. Cyclophosphamide induced a highly significant increase (p < 0.001) in the frequency of MPE, indicating the sensitivity of the test system under our experimental conditions. The study was therefore considered to be valid.
The mean values of the PE/NE ratio in the groups treated with the test item were equivalent to those of the vehicle group, showing there is no evidence of test article related bone marrow toxicity. The mean values of MPE in the groups treated with the test item (1.0, 1.1, 1.0 MPE/1000 PE for the male groups; 1.0, 1.4 and 0.6 MPE/1000 PE for the female groups at 100, 200 and 400 mg/kg bw, respectively) were equivalent to those of the vehicle control group (0.8 and 0.9 MPE/1000 PE for the males and females, respectively). There are no statistically significant increases in the frequency of MPE for the test item-treated groups when compared to the concurrent vehicle control group. Therefore, the criteria for a positive response are not met, thus it is concluded that, in this study, the test item did not induce damage to the chromosomes or the mitotic apparatus of rat bone marrow cells.
Under the experimental conditions of the study, the test item, 2-[(1-methylpropyl)amino]ethanol, did not induce damage to the chromosomes or the mitotic apparatus of rat bone marrow cells after two oral administrations, at a 24-hour interval, at the dose-levels of 100, 200 and 400 mg/kg/day.
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