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EC number: 266-959-4 | CAS number: 67707-75-9
- 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:
- supporting study
- 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:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male Wistar rats were exposed to 1 percent of the test item in 40 percent alcohol for 1 h (whole body exposure).
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl 3,5,5-trimethylhexanoate
- EC Number:
- 266-959-4
- EC Name:
- Ethyl 3,5,5-trimethylhexanoate
- Cas Number:
- 67707-75-9
- Molecular formula:
- C11H22O2
- IUPAC Name:
- ethyl 3,5,5-trimethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): 3,5,5-Trimethyl-ethyl-capronat
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann GmbH, D-Borchen
- Age at study initiation: young adult
- Weight at study initiation: 130 – 150 g
- Fasting period before study: no (only during inhalation exposure period)
- Housing: in type 3 makrolon cages
- Diet (e.g. ad libitum): Altromin maintainance diet, 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 22
- Humidity (%): approx. 50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: 40% ethanol
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation exsiccator
- Exposure chamber volume: no data
- Source and rate of air: 200 L/h
- System of generating particulates/aerosols: nebuliser
TEST ATMOSPHERE
- Brief description of analytical method used: no data
VEHICLE
- Composition of vehicle (if applicable): 40% EtOH
- Concentration of test material in vehicle (if applicable): 1%
- Justification of choice of vehicle: relatively intoxic to rat
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 1 h
- Concentrations:
- 1% in vehicle, corresponding to 1000 mg/m³ air
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology of upper trachea, mid trachea, lung (3 test animals + 3 control animals)
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 1 000 mg/m³ air (nominal)
- Based on:
- act. ingr.
- Exp. duration:
- 1 h
- Remarks on result:
- other: no mortality
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 250 mg/m³ air (nominal)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Remarks on result:
- other: extrapolated from 1 h value
- Mortality:
- no animals died
- Clinical signs:
- other: no clinical signs apart from temporarily impaired general condition directly after inhalation exposure
- Body weight:
- no data
- Gross pathology:
- Pathologically and histologically no compound specific alterations of the target organs (respiratory tract) could be observed.
- Other findings:
- Slight to moderate tracheitis was observed in all examined animals (test and control group). The lungs of all examined animals showed moderate to marked focal interstitial pneumonia, often combined with bronchitis and/or bronchopneumonia. In trachea and lung no qualitative or quantitative difference was observed between control and test group animals. Thus, the test substance did not show any specific substance related effects to the respiratory tract.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The 1 h LC0 of 3,5,5-Trimethyl-ethyl capronate in male rats was 1000 mg/m³ air.
- Executive summary:
In an acute inhalation toxicity screening study, groups of 5 male young adult Wistar rats were exposed by inhalation route to 3,5,5-Trimethyl-ethyl capronate in 40% Ethanol for 1 hour to whole body at concentrations of 0 and 1%. Animals then were observed for 7 days.
No animals died at the limit concentration of 1% in 40% Ethanol. No clinical signs apart from temporarily impaired general condition directly after inhalation exposure were observed.
Slight to moderate tracheitis was observed in all examined animals (test and control group). The lungs of all examined animals showed moderate to marked focal interstitial pneumonia, often combined with bronchitis and/or bronchopneumonia. In trachea and lung no qualitative or quantitative difference was observed between control and test group animals. Thus, the test substance did not show any specific substance related effects to the respiratory tract.
The 1 h LC0 was >= 1% test substance in 40% Ethanol, corresponding to 1000 mg/m³.
“The ranges of the acute toxicity estimates (ATE) for inhalation toxicity [according to Regulation (EC) No 1272/2008] are based on 4-hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1-hour exposure can be carried out by dividing by a factor of […] 4 for dusts and mists.”
Based on this, a factor of 4 was used to extrapolate from 1 h exposure to 4 h exposure, resulting in a 4 h LC0 Males >= 0.25 mg/L air.
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