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EC number: 630-324-3 | CAS number: 861229-15-4
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 19, 1992 - September 9, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1150 (Acute inhalation toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA FIFRA 81-3
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes
- Test type:
- fixed concentration procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate
- EC Number:
- 630-324-3
- Cas Number:
- 861229-15-4
- Molecular formula:
- C18H27ClO3
- IUPAC Name:
- 2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK
- Age at study initiation: 6 weeks (male) and 8 weeks (female)
- Weight at study initiation: ca. 200 g
- Housing: stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C - 24°C
- Humidity (%): 25% - 65%
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.2 µm
- Geometric standard deviation (GSD):
- 2.31
- Remark on MMAD/GSD:
- The proportion of droplets in the sub-micron size range was 17.8% and lower that EPA specification of 25%. Calculations show, that the 25% level was reached at a particle size of 1.23 µm.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: aerosol generator; test substance was supplied from syringe driven at a constant rate by a syringe pump
- Exposure chamber volume: chamber with an internal volume of 120 L
- Method of holding animals in test chamber: chamber divided by wire mesh partitions to provide 10 separate animal compartments
- Source and rate of air: flow rate of 0.6 mL/min to give a concentration of 5 mg/L of air
- Temperature in air chamber:mean 23°C measured at the start and then at 30-minute intervals during exposure
TEST ATMOSPHERE
- analytical method used: HPLC
- Samples taken from breathing zone: yes, 5 samples during exposure - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 0 and 4.66 mg/L (highest achieved concentration)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continuously during exposure and at least twice daily throughout the observation period; daily weighting from start until the end of the experiment
- Other examinations performed: food and water consumption was measured daily; macroscopic examination of all animals, lungs, liver and kidneys examined
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.66 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One exposed female died overnight following exposure.
- Clinical signs:
- other: CLINICAL SIGNS. During exposure : signs consistent with exposure to an irritant aerosol, including partial closing of the eyes, wetness around the mouth and snout, and exaggerated respiratory movements. During observation period: signs seen in rats includ
- Body weight:
- Reduced bodyweight or reduced rate of bodyweight gain was evident for up to 5 days following exposure. Subsequently, weight gain was similar to that for control rats.
- Gross pathology:
- The lung weight to bodyweight ratio for the rat that died was higher than for the surviving rats.
Macroscopic pathology: the lungs of the rat that died following exposure the substance were congested and the stomach was gas-filled. - Other findings:
- - Organ weights:
The lung weights were within normal limits for the control rats and for the surviving rats exposed to the test substance.. For the rat taht died the lung weight to bodyweight ratio was higher than for the surviving rats.
- Histopathology: The lungs of one rat exposed to the test substance were congested and the stomach was gas-filled. There were no abnormalities in any other rat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 (4-hour) for MCPP-P 2-EHE is in excess of 4.66 mg/L. This was the highest attainable concentration.
- Executive summary:
In a GLP study according to OECD 403, the acute inhalation toxicity of MCPP-P 2-EHE was assessed by exposing a group of rats to an aerosol produced from the test item. The control group was exposed to air only. The exposure duration was 4 hour in a whole body chamber followed by a 14-days observation period. The concentration of aerosol was measured during the exposure and the particle size distribution was assessed as well.
One female died following exposure and all animals showed signs of constant exposure to an irritant aerosol, including partial closing of the eyes, wetness around the mouth and snout and exaggerated respiratory movements. During the observation period, rats showed abnormal breathing, lethargy, wet fur, matted or oily fur and brown staining around the snout and jaws, but all surviving rats exposed to the test item were normal by day 8 of observation. The body weight was reduced for up to 5 days following exposure to MCPP-P 2-EHE but subsequently, weight gain was similar to that for control rats. Food consumption was reduced for up to one day following exposure and water consumption increased and remained high for several days following exposure to the test item. The lung weight to bodyweight ratios for rats surviving expose were within normal limits.
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