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EC number: 264-036-0 | CAS number: 63225-53-6
- 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:
- 20 Oct 2015 - 20 Jan 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- adopted in 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2-[[(butylamino)carbonyl]oxy]ethyl acrylate
- EC Number:
- 264-036-0
- EC Name:
- 2-[[(butylamino)carbonyl]oxy]ethyl acrylate
- Cas Number:
- 63225-53-6
- Molecular formula:
- C10H17NO4
- IUPAC Name:
- 2-[[(butylamino)carbonyl]oxy]ethyl acrylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Research Models and Services Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks (males), 9 weeks (females)
- Weight at study initiation: 239 - 270 g (males) and 218 - 250 g (females)
- Fasting period before study: animals were fasted approximately 16 hours prior to administration.
- Housing: Enter as given in the study report. in groups of 2-3 animals of the same sex per cage in MAKROLON cages (type III plus), Granulated textured wood (Granulat A2, J. Brandenburg, Goldenstedt, Germany), cages were changed and cleaned twice a week.
- Diet: Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany)(analysis was performed); ad libitum (except for fasting period)
- Water: tap water; ad libitum (analysis was performed)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Example: 22 ± 3
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
(IN-LIFE DATES: From: 04 Nov 2015 To: 20 Jan 2016)
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: no vehicle (unchanged test item was used)
- Mass median aerodynamic diameter (MMAD):
- >= 3.373 - <= 3.629 µm
- Geometric standard deviation (GSD):
- >= 3.05 - <= 3.19
- Remark on MMAD/GSD:
- No smaller GSD values could be obtained with the test item supplied.
- Details on inhalation exposure:
- EXPOSURE SYSTEM
- dynamic inhalation chamber (air changes/h (≥ 12 times))
- nose-only exposure according to KIMMERLE & TEPPER
- The apparatus consists of a cylindrical exposure chamber (volume 40 L) which holds the animals in pyrex tubes at the edge of the chamber in a radial position.
- Actual dimensions of the Inhalation Chamber: Inner Diameter: 28.2 cm; Height: 64.6 cm; Volume: 40.3 L
ADMINISTRATION:
- The aerosol of the test item was generated using a spray-jet.
- The spray-jet was fed with compressed air (5.0 bar) from a compressor and with the test item using an infusion pump.
- At the bottom of the exposure chamber, the air was sucked off at a lower rate than created by the spray-jet in order to produce a homogenous distribution and a positive pressure in the exposure chamber (inflow 900 L/h, outflow 800 L/h).
- Control of the constant supply of compressed air and the exhaust via a manometer or an air-flow meter, respectively.
- The oxygen content in the inhalation chamber was 21% v/v.
- Particle size distribution (determined via a cascade impactor): See Table 1 under "any other information on materials and methods incl. tables"
CLASS METHOD
- Rationale for the selection of the starting concentration: Maximum recommended concentration - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrical
- Duration of exposure:
- 4 h
- Concentrations:
- 0.52, 1.05 or 5.06 mg/L air
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily until all symptoms subsided, thereafter each working day, and individual body weights were determined before the exposure on test day 1 and on test days 2, 4, 8 and 15 and at the time of death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma, changes in the skin and fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, as well as somatomotor activity and behaviour pattern); determination of lung weights
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.5 - < 1 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- 5.06 mg/L air: 3/3 males and 3/3 females died
1.05 mg/L air: 3/3 males and 3/3 females died
0.52 mg/L air: No mortality.
For details refer to Table 2 under "any other information on results". - Clinical signs:
- other: 5.06 and 1.05 mg/L air: moderately reduced motility, moderate ataxia, slight tremor, severe dyspnoea, lacrimation and vocalisation in 3/3 males and 3/3 females 0.52 mg/L air: slightly reduced motility, slight ataxia, slight tremor, moderate dyspnoea, lacr
- Body weight:
- 5.06 and 1.05 mg/L air: all animals died prematurely
0.52 mg/L air: No inhibition of body weight gain in 3/3 males and 3/3 females. - Gross pathology:
- 5.06 and 1.05 mg/L air: Necropsy revealed oedematous or emphysematous lungs in 3/3 males and 3/3 females (refer to Table 3 under "any other information on results").
0.52 mg/L air: No change at necropsy. - Other findings:
- Organ weights (lung tissue) were determined. Refer to Table 3 under "any other information on results".
Any other information on results incl. tables
Table 2: Table for acute inhalation toxicity
Target Concentration [mg/L air] |
Mortality |
Clinical Signs |
|
N* |
N* |
Males |
||
0 |
0/5 |
0/5 |
1.337 |
0/5 |
0/5 |
2.871 |
0/5 |
0/5 |
Females |
||
0 |
0/5 |
0/5 |
1.337 |
0/5 |
0/5 |
2.871 |
0/5 |
0/5 |
*N= Number of animals/ number of animals used
Table 3: Necropsy findings
Target concentration [mg/L air] |
Animal (sex/number) |
Tissue |
Finding |
Organ Weight (lung) [g] |
5.06 |
m / 1 |
lung |
oedematous |
1.73 |
|
m / 2 |
lung |
oedematous |
1.92 |
|
m / 3 |
lung |
oedematous |
2.53 |
|
f / 1 |
lung |
emphysematous |
4.02 |
|
f / 2 |
lung |
oedematous |
1.78 |
|
f / 3 |
lung |
emphysematous |
4.33 |
1.05 |
m / 1 |
lung |
oedematous |
2.18 |
|
m / 2 |
lung |
oedematous |
1.90 |
|
m / 3 |
lung |
oedematous |
3.78 |
|
f / 1 |
lung |
oedematous |
2.62 |
|
f / 2 |
lung |
oedematous |
2.11 |
|
f / 3 |
lung |
oedematous |
2.70 |
0.52 |
m / 1 |
lung |
none |
1.56 |
|
m / 2 |
lung |
none |
1.72 |
|
m / 3 |
lung |
none |
1.44 |
|
f / 1 |
lung |
none |
1.19 |
|
f / 2 |
lung |
none |
1.23 |
|
f / 3 |
lung |
none |
1.21 |
m = male; f = female |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS Category 3 (H331) according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Acute Inhal. 3, H331
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