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EC number: 604-351-6 | CAS number: 143390-89-0
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study (only two dose levels)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- 2 dose levels
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
- EC Number:
- 604-351-6
- Cas Number:
- 143390-89-0
- Molecular formula:
- C18 H19 N O4
- IUPAC Name:
- methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
- Details on test material:
- - Name of test material (as cited in study report): Reg. No. 242 009 (test substance number: 91/180)
- Lot/batch No.: N 30 (= IIIa2); date of manufacturing: 1991-06-17
- Physical state: solid (powder) / light brown
- Storage condition of test material: room temperature, exclusion of light
- Physical state: solid (powder) / light brown
- Analytical purity: 96.6% (Reversed-Phase - HPLC with UV-Detection; certificate of analysis is available)
- Stability under test conditions: the storage stability was guaranteed over the study period
- Other: the homogeneity of the test substance was confirmed by analysis (Reversed-Phase - HPLC with UV-Detection)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHBB: Thom (SPF); from Dr. K. Thomae GmbH, D-W7950 Biberach, FRG
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: animals of comparable weight (means of 278±10.6 for male and 197±4.9 for male animals).
- Fasting period before study: 16 hours, but water was available ad libitum
- Housing: singly in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet (e.g. ad libitum): Kliba rat/mouse/hamster laboratory diet 24-343-4 10 mm pellets, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water: tap water (e.g. ad libitum only during the post exposure observation period)
- Acclimation period: at leat one week
ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (6:00 - 18:00 / 18:00 - 6:00 hours)
Administration / exposure
- Route of administration:
- other: inhalation: dust aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: see below
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-nose inhalation system INA 20 (glass-steel construction;BASF AG)
- Exposure chamber volume: 55 l
- Method of holding animals in test chamber: the animals were restrained in tubes and their snouts projected into the inhalation chamber.
- Source and rate of air: By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10% lower (excess pressure). This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals. The inhalation atmosphere was offered to the animals for inhalation for 4 hours. Air flow was adjusted to 1500 l/hour
- Method of conditioning air: The exposure system was placed in an air-conditioned laboratory.
- System of generating particulates/aerosols: the test substance was mixed with 1 (w/w)% of Aerosil in order to achieve a more uniform dust concentration in air. The aerosol was produced with dust generator [dosing-wheel dust generator (Gericke/BASF)] and compressed air [glass cyclonic separator (BASF)]. A cyclonic separator was connected downstream with the generator. The concentration was adjusted by varying the rotation of the metering disc.
- Method of particle size determination: 30 minutes after the beginning of the test at the earliest, one sample was taken per test group for the particle size analysis. Before the sampling, an impactor was equipped with glass-fiber collecting discs and a backup particle filter. The impactor was connected to the pump and the test apparatus, and the samples (9 - 24 l) were taken. The impactor was taken apart and the collecting discs and the backup particle filter were weighed. The contents of the pre-impactor as well as the amounts of the material adsorbed on the walls of the impactor and in the sampling probe (wall losses) were also determined quantitatively.
- Treatment of exhaust air: not specified
- Temperature, humidity, pressure in air chamber: The humidity in the inhalation systems were not measured due to technical reasons. It is assumed that deviations of humidity values from the guideline requirements (especially low humidity in dust aerosol) did not influence the test results because of the relative short exposure time. The temperatures in the inhalation systems were measured continuously and recorded once. Only deviations from the temperature range (22±2°C) of the OECD Guideline will be reported in the result section.
TEST ATMOSPHERE
- Brief description of analytical method used: A pre-weighed filter was placed into the filtration equipment. By means of a vacuum compressed air pump a volume of the dust aerosol was drawn through the filter. The dust concentration in mg/l was calculated from the difference between the pre-weight of the filter and the weight of the filter after sampling, with reference to the sample volume of the inhalation atmosphere. The concentrations were corrected for the amount of the added excipient.
- Samples taken from breathing zone: yes; immediately adjacent to the animals noses
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: the generated aerosols were well inhalable
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.8 / 2.4 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- see above (the nominal concentration was calculated from the amount of substance consumed and the air flow.)
- Duration of exposure:
- 4 h
- Concentrations:
- 2.04 and 5.6 mg/l (analytical concentrations)
- No. of animals per sex per dose:
- 5
- Control animals:
- other: historical air control data included
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the body weight of the animals was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings were recorded for each animal separately several times during exposure and at least once on each workday in the observation period. A check for dead animals was made daily.
- Necropsy of survivors performed: yes, at the end of the 14-day observation period the animals were sacrificed with CO2 and were subjected to gross-pathological examination. - Statistics:
- The statistical evaluation of the dose-response relationship was carried out using FORTRAN program AKPROZ: Depending on the data of the dose-response relationship obtained by way of experiment, this program is used to estimate the LC50 or to perform a Probit analysis. Estimation of the LC50 will produce 3 types of LC50 (LC50 greater, LC50 about, or LC50 smaller). If the results are Type LC50 greater or LC50 smaller, an additional binominal test is carried out, in order to verify these statements statistically, if necessary.
The calculation of the particle size distribution was carried out in the Department of Toxicology of BASF AG on the basis of mathematical methods for evaluating particle measurements.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.6 mg/L air (analytical)
- Exp. duration:
- 4 h
- Remarks on result:
- other: the statistical reliability is 99%; no deaths occurred but some clinical signs were observed on day 1 (see below).
- Mortality:
- no mortalities were observed
- Clinical signs:
- other: - In the low concentration clinical examination revealed attempts to escape, accelerated and intermittent respiration, urine smeared fur and fur contamination in all, as well as reddish nose and eye discharge and reddish eyelid crusts in single male anima
- Body weight:
- Body weight gain was not affected in both concentrations during the whole post-exposure period (see Table 1).
- Gross pathology:
- During necropsy no macroscopic pathologic findings were noted.
Any other information on results incl. tables
Table 1: Body weight development
Treatment group (mg/l) |
Mean body weight (g) after |
|||||
0 day |
7 days |
14 days |
||||
Males |
Females |
Males |
Females |
Males |
Females |
|
2.04 |
271 |
194 |
307 |
206 |
334 |
215 |
5.6 |
285 |
200 |
309 |
211 |
347 |
225 |
Historical air control weight |
248 |
177 |
286 |
196 |
318 |
211 |
Applicant's summary and conclusion
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.
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