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EC number: 906-484-8 | CAS number: -
- 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:
- June 03, 2010 - June 18, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP with certificate; OECD guidance; no deviation to the study plan
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(propan-2-yloxy)propane; 2-methylpent-2-ene
- EC Number:
- 906-484-8
- Molecular formula:
- Not applicable as multiconstituent substance.
- IUPAC Name:
- 2-(propan-2-yloxy)propane; 2-methylpent-2-ene
- Details on test material:
- - Lot/batch No.: 10013591
- Expiration date of the lot/batch: March 2011
- Storage condition of test material: In refrigerator at 2-8 ºC, under inert gas, away from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Species / Strain: Rat, CRL (WI) BR of Wistar origin
Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
Hygienic level: SPF at arrival and kept in good conventional environment during the study.
Age of animals at arrival: Young adult rats, 7-9 weeks old
Body weight range at treatment: Male: 327-334 g; Female: 194-207 g
Number of animals: 5 male and 5 female (nulliparous and non pregnant animals) rats
Number of animals/group: 5 animals/ sex
Acclimatisation time: 21 days
Acclimatisation to the test apparatus: 17 days
- Fasting period before study: no
- Housing: Group caging (2 or 3 animals, by sex, per cage)
- Diet (e.g. ad libitum): The animals received ssniff® SM R/M-Z+H complete diet produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum.
- Water (e.g. ad libitum): Animal received tap water from watering bottles. The drinking water is periodically analysed and is considered not to contain any contaminants
Environmental conditions:
Illumination: Artificial light, from 6 a.m. to 6 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 8-12 air exchanges/hour by central air-condition system.
Environmental conditions were maintained by an air-condition system. Temperature and relative humidity were verified and recorded daily during the study.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: anodised aluminium Flow Past Exposure Chamber (CR Equipment SA, Switzerland)
- Exposure chamber volume: 6 L
- Method of holding animals in test chamber: polycarbonate restraining tubes
- Source and rate of air: rate: Source: no data; 1.0 L/min
- Method of conditioning air: The air was supplied by an oil-free air compressor and was filtered in a two-stage filter set (Festo: 1μm and 0.01 μm). The temperature of the air was regulated by a heat exchanger. The air was not humidified in order to avoid modification of particle size distribution.
- System of generating particulates/aerosols: The test atmosphere was generated by a compressed air nebulizer (TSE Systems GmbH, Bad Homburg, Germany.) In the nebulizer the air flow rate was 15 L/min.
- Method of particle size determination: 7-stage cascade impactor type 02-150 (IN-TOX Products, N.M., USA)
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: 23.8-26.3 °C; 26.5-9.1 % relative humidity; pressure: no data
TEST ATMOSPHERE
- Brief description of analytical method used: The actual test atmosphere concentration was measured five times during exposure by pulling a volume of 10 L of test atmosphere (flow rate: 2.0 L/min) through sampling cylinders (length: 100mm, dia. 30mm) tightly filled with about 20g of granulated activated carbon (Reanal Private Ltd., Prod. No. 29903-1-99-33, pellet diameter 4mm). The amount of adsorbed test item was determined gravimetrically by the balance type Mettler PM100 (d = 1mg).
- Samples taken from breathing zone: yes
VEHICLE
no vehicle used
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: see any other information on materials and methods
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
MMAD: Mass Median Aerodynamic Diameter (mean): 0.59 μm
GSD: Geometric Standard Deviation (mean): 1.35
Inhalable Fraction: Aerodyn. Diameter < 4μm: 100 %
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: upper limit of the classification into acute toxicity category 4 according to the CLP-regulation. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- method see above
- Duration of exposure:
- 4 h
- Remarks on duration:
- nose-only exposure
- Concentrations:
- 22.9 mg/L (Mean Achieved Concentration)
- No. of animals per sex per dose:
- 5 Males, 5 Females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were checked twice daily during the observation period for morbidity and/or mortality.
All animals were observed for clinical signs at 1st, 2nd and 3rd hours during exposure, as soon as practicable following removal from restraint, one hour after exposure and subsequently once daily for fourteen days.
Individual bodyweights were recorded on the day of exposure Day 0 (prior to exposure) and Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes; At the end of the fourteen day observation period, the animals were euthanized by exsanguination under anaesthesia (intra-peritoneal injection of Euthasol® 40%) and gross necropsies were performed. These included a detailed examination of the abdominal and thoracic cavities with special attention given to the respiratory tract for macroscopic signs of irritancy or local toxicity.
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 22.9 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- There was no died animal during the study.
- Clinical signs:
- other: All male and female animals were symptom-free during the day of treatment and observation period. Only in one animal was found any porphyrin discharge around the left eye during the treatment period. This animal became symptom-free one hour after exposure
- Body weight:
- On basis of body weight and body weight gain data, there was no notable test item effect observable in the exposed animals.
- Gross pathology:
- A single four hours nose-only exposure of reaction mass of DIPE and 2-methylpent-2-ene to CRL: (WI) BR rat followed by a 14-day observation period at a dose level 20 mg/L was not associated with any test item-related macroscopic findings.
Any other information on results incl. tables
Individual Body weight data:
Sex |
Animal Number |
Body weight (g) |
Weekly Increase (g) |
|||||
Day 0 |
Day 1 |
Day 3 |
Day 7 |
Day 14 |
Week 1 |
Week 2
|
||
Male |
5878 |
329 |
331 |
336 |
363 |
405 |
34 |
42 |
5879 |
329 |
330 |
333 |
362 |
406 |
33 |
44 |
|
5880 |
327 |
334 |
340 |
366 |
415 |
39 |
49 |
|
5885 |
334 |
328 |
336 |
364 |
410 |
30 |
46 |
|
5886 |
327 |
324 |
334 |
361 |
398 |
34 |
37 |
|
Mean: |
|
329.2 |
329.4 |
335.8 |
363.2 |
406.8 |
34 |
43.6 |
*Difference in % |
|
|
0.1 |
1.9 |
8.2 |
12.0 |
10.3 |
12.0 |
Female |
5906 |
202 |
206 |
207 |
218 |
239 |
16 |
21 |
5908 |
194 |
202 |
206 |
220 |
228 |
26 |
8 |
|
5910 |
207 |
204 |
210 |
224 |
237 |
17 |
13 |
|
5920 |
205 |
202 |
210 |
222 |
238 |
17 |
16 |
|
5923 |
202 |
200 |
207 |
230 |
240 |
28 |
10 |
|
Mean: |
|
202.0 |
202.8 |
208.0 |
222.8 |
236.4 |
20.8 |
13.6 |
*Difference in % |
|
|
0.4 |
2.6 |
7.1 |
6.1 |
17.0 |
6.1 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LC50 inhalation, rat, for gases or vapours is >20 mg/litre/4h. Consequently, Reaction mass of 2-methylpent-2-ene and diisopropyl ether must not be classified for acute toxicity-inhalation.
- Executive summary:
Under the experimental conditions of this study, no deaths occurred in a group of ten rats exposed to a mean achieved test item concentration of 22.9 mg/L for four hours. The acute inhalation median lethal concentration (4hr LC50) of test itemreaction mass of DIPE and 2-methylpent-2-ene, in Wistar Crl:(WI) BR rats, was therefore considered to be greater than 22.9 mg/L.
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