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EC number: 230-386-8 | CAS number: 7085-19-0
- 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:
- key study
- Study period:
- 04 August 1986 to 30 September 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Mecoprop
- EC Number:
- 230-386-8
- EC Name:
- Mecoprop
- Cas Number:
- 7085-19-0
- Molecular formula:
- C10H11ClO3
- IUPAC Name:
- 2-(4-chloro-2-methylphenoxy)propanoic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Storage conditions: At room temperature.
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 8 - 9 weeks.
- Weight at study initiation (mean ± s.d.): Male: 284 ± 19.8 g, female: 189 ± 14.2 g.
- Housing: Animals were housed in groups of five (test groups 1 and 2 and the male rats animal number 1 - 5 of the test group 3); from day 2 onward the male animals, animal number 6 - 10 of the test group 3 were housed singly (indications of not substance related aggressivity) in cages type D III of Becker, without bedding.
- Diet: Ad libitum during the post-exposure observation period
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: The test material was milled and mixed with 1 wt % of Aerosil to achieve a more uniform dust concentration in air.
- Mass median aerodynamic diameter (MMAD):
- 5.6 µm
- Geometric standard deviation (GSD):
- 2.3
- Remark on MMAD/GSD:
- Test group 1
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-nose inhalation system INA 20 (glass-steel construction, BASF. Aktiengesellschaft, volume V ~ 55 1) : the animals were restrained in tubes and their snouts projected into the inhalation chamber.
-Generation on inhalation atmosphere: A dust air mixture was generated by means of a vibration dust partitioning equipment (BASF). The test material was milled and mixed with 1 wt % of Aerosil in order to achieve a more uniform dust concentration in air. The concentration was adjusted by varying the apertural width and by varying the amplitude of oscillations of the metering beaker.
- The following air flows were set: 1500 l/h compressed air through the injector and 1500 l/h conditioned air as dilution air. The supply air was conditioned via a central air-conditioning system in such a way that there was a temperature of 19 - 25 °c in the exposure apparatus. Deviations from this specification which would have had any adverse effect on the results of the study did not occur.
-The inhalation mixture was offered to the animals for inhalation for 4 hours.
-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 material and air was not diluted with laboratory air in the breathing zones of the animals.
TEST ATMOSPHERE
- Nominal concentration: The nominal concentration was calculated from the amount of test material -1 wt % excipient and the air flow.
- Sampling apparatus:
Vacuum compressed air pump: (Millipore) XX 60 220 50
Filtration equipment with probe (Millipore) (internal diameter: 4 mm)
Filter: MN 85/90 Bf (d = 4.7 cm)
Sampling velocity: 1.25 m/s
Sampling amount: 11 - 21
Sampling position: immediately adjacent to the animals’ noses
Sampling frequency: 1 sample about hourly for test group 3, and 1 sample about every 30 minutes for the test groups 1 and 2.
- Analytical determination method: Gravimetric determination of the inhalation atmosphere concentration
Equipment: balance: Mettler HL 52
The 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.
- Particle size analysis:
Equipment:
- Andersen Stack Sampler Hark III
- Millipore Vacuum Compressed Air Pump XX 60 220 50
- Sampling probe (internal diameter 6.9 mm)
- Stopwatch
Procedure:
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, the 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 one sample (3 - 9 L) was taken. The impactor was taken apart, 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.
RESULTS OF ANALYTICAL MEASUREMENTS
Concentration measurements: Each individual sample was analysed. The following are summaries of the results per group:
-Test group 1:
Mean uncorrected: 12.6 mg/L
Mean corrected for excipient: 12.5 mg/L
Standard deviation of the mean: ± 2.32 mg/L
Nominal concentration: 42.9 mg/L
-Test group 2:
Mean uncorrected: 9.6 mg/L
Mean corrected for excipient: 9.5 mg/L
Standard deviation of the mean: ± 1.27 mg/L
Nominal concentration: 28.0 mg/L
-Test group 3:
Mean uncorrected: 5.5 mg/L
Mean corrected for excipient: 5.4 mg/L
Standard deviation of the mean: ± 1.36 mg/L
Nominal concentration: 10.5 mg/L
RESULTS OF PARTICLE SIZE ANALYSES
- Test group 1:
MMAD 50%: 5.6 µm (geometric standard deviation = 2.3)
Respirable dust fraction that might reach alveoli of: 83 %.
- Test group 2:
MMAD 50%: 6.2 µm (geometric standard deviation = 2.3)
Respirable dust fraction that might reach alveoli of: 77 %.
- Test group 3:
MMAD 50%: 4.1 µm (geometric standard deviation = 2.3)
Respirable dust fraction that might reach alveoli of: 91 %. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.4, 9.5 and 12.5 mg/L.
The selection of the concentration for test group 3 was based on the limit test, OECD Test Guidelin 403. The other concentrations were selected in order to achieve an estimation of the LD50. - No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- not specified
- 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 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 surviving animals were sacrificed with CO2 and were subjected to gross-pathological examination like all other animals which had died before. To clarify the gross pathological findings selected organs of individual animals were examined histopathologically. - Statistics:
- The statistical evaluation of the test was carried out in accordance with a probit analysis of D.J. Finney (0.J. Finney; Probit Analysis 1971, pp. 1 - 150. Published by the Syndics of the Cambridge University Press, Bentley House, 200 Euston Road, London N.W.1.).
The particle size was determined in the Department of Toxicology of BASF Aktiengesellschaft on the basis of mathematical methods for evaluating particle measurements (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235 - 259).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 12.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum achievable concentration tested.
- Mortality:
- Test group 1 (12.5 mg/L): 5/20 animals had died by day 14.
Test group 2 (9.5 mg/L): 4/20 animals had died by day 14.
Test group 3 (5.4 mg/L): 3/20 animals had died by day 14. - Clinical signs:
- irregular respiration
- Body weight:
- A significant retarded body weight gain of female and male rats of all test groups compared with a historical control collective was observed.
- Gross pathology:
- Animals that died spontaneously (males and females):
5.4 mg/L: General congestion, Lung - slight oedematisation.
9.5 mg/L: General congestion
12.5 mg/L: Lung: some slightly sunken darker areas, with irregular margins.
Sacrificed animals (males and females):
- Organs: No abnormalities detected.
- Microscopic findings: 12.5 mg/L: One male animal that died - Beginning focal Bronchopneumonia.
Any other information on results incl. tables
Clinical Signs
- During exposure: single attempts to escape; irregular to jerky respiration; reddish nasal discharge (blood test positive).
- After exposure: irregular to jerky respiration; sounds of respiration; unsteady gait: noses partly with reddish smear or encrustations; reduced state of health: apathy; some male rats showed aggressivity (only test group 3).
- As of day 7 of the observation period, for the test group 1 and 3: day 12 for the test group 2 no abnormalities were detected in the animals.
Mortality in the Study
Cumulated Lethality on Day | Test Group (Concentration) | |||||
1 (12.5 mg/L) | 2 (9.5 mg/L) | 3 (5.4 mg/L) | ||||
M | F | M | F | M | F | |
0 | 2/10 | 0/10 | 2/10 | 2/10 | 2/10 | 1/10 |
1 | 3/10 | 2/10 | - | - | - | - |
2 | - | - | - | - | - | - |
7 | - | - | - | - | - | - |
14 | - | - | - | - | - | - |
Total at end of the study | 5/20 | 4/20 | 3/20 |
M = Male, F = female
- = Lethality unchanged
0 = Day of exposure
Body Weight
Mean Body Weight | Before the Study | After 7 Days | After 14 Days | ||||
Male | Female | Male | Female | Male | Female | ||
Test group 1 | Weight in g | 300 | 203 | 313 | 213 | 337 | 217 |
No. of animals | 10 | 10 | 7 | 8 | 7 | 8 | |
Test group 2 | Weight in g | 261 | 177 | 268 | 184 | 304 | 196 |
No. of animals | 10 | 10 | 8 | 8 | 8 | 8 | |
Test group 3 | Weight in g | 292 | 187 | 291 | 195 | 328 | 206 |
No. of animals | 10 | 10 | 8 | 9 | 8 | 9 | |
Historical (air) control | Weight in g | 248 | 177 | 285 | 196 | 317 | 210 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, the acute inhalation LC50 (4 h) of the test material was found to be >12.5 mg/L.
- Executive summary:
The acute inhalation toxicity of the test material was investigated in a study design based on the OECD 403 guideline. The study was conducted under with GLP conditions.
10 male and 10 female Wistar rats per group were exposed to concentrations of 5.4, 9.5 and 12.5 mg/L of the active ingredient for a period of 4 hours.
During the exposure the following clinical signs were observed: single attempts to escape, irregular to jerky respiration, reddish nasal discharge. After the exposure irregular to jerky respiration, sounds of respiration, unsteady gait, noses partly with reddish smear or encrustations, reduced state of health and apathy were observed. In animals that died during the exposure period general congestion, slight oedematisation and some slightly sunken darker areas at the lung were found. In sacrificed animals no abnormalities were observed.
Under the conditions of this study, the acute inhalation LC50 (4 h) of the test material was found to be >12.5 mg/L.
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