Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-319-2 | CAS number: 94-28-0
- 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:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
- EC Number:
- 202-319-2
- EC Name:
- 2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)
- Cas Number:
- 94-28-0
- Molecular formula:
- C22H42O6
- IUPAC Name:
- 2-(2-{2-[(2-ethylhexanoyl)oxy]ethoxy}ethoxy)ethyl 2-ethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): 3GO / Triethylene Glycol Di-2-Ethylhexanoate
- Physical state: straw colored liquid
- Purity: 98.3%
- Impurities (identity and concentrations): not provided
- Stability under test conditions: The test substance appeared to be stable under the conditions of the study; no evidence of instability was observed.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)IGS BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina
- Age at study initiation: approximately 7 weeks old on the day of arrival
- Housing: Except during exposure, animals were housed singly
- Diet (e.g. ad libitum): ad libitum except during exposure (PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002)
- Water (e.g. ad libitum): ad libitum except during exposure (tap water)
- Acclimation period: Rats were quarantined after arrival for 6 days prior to testing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Relative humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): approximate 12-hour light/dark cycle
IN-LIFE DATES: From: January 18, 2005 To: February 21, 2005
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus and exposure chamber volume: The exposure chamber was constructed of glass (cylindrical) with a nominal internal volume of 34 L. A polycarbonate baffle inside the chamber promoted uniform chamber distribution of the test atmosphere.
- Method of holding animals in test chamber: During exposure, animals were individually restrained in perforated stainless steel cylinders with conical nose pieces. The restrainers were inserted into a polymethylmethacrylate faceplate attached to the exposure chamber so that the nose of each animal extended into the exposure chamber.
- System of generating particulates/aerosols: Chamber atmospheres were generated by aerosolization of the test substance in air with a Spraying Systems nebulizer. The test substance was metered into the nebulizer with a Harvard Apparatus model 22 syringe infusion pump. Filtered, high-pressure air, metered into the nebulizer by a Brooks model 0154E mass flow controller, carried the resulting atmosphere into the exposure chamber. Chamber concentrations of test substance were controlled by varying the rate of the infusion pump.
- Treatment of exhaust air: Test atmospheres were exhausted through a dry-ice cold trap followed by an MSA charcoal/HEPA filter cartridge prior to discharge into the fume hood.
- Temperature, humidity, pressure in air chamber: Chamber temperature was 24°C, relative humidity ranged from 46 - 50%, airflow was 16.0 L/min and the oxygen concentration was 21.0%.
TEST ATMOSPHERE
- Brief description of analytical method used: During each exposure the atmospheric concentration of the test substance was determined by gravimetric analysis at approximately 30-minute intervals in the test chamber. Known volumes of chamber atmosphere were drawn from the sampling port through a 25 mm filter cassette containing a pre-weighed glass fiber (Type A/E) filter. The filters were weighed on a Cahn model C-31 Microbalance®. The atmospheric concentration of the test substance was calculated from the difference between the pre- and postsampling filter weights divided by the volume of chamber atmosphere sampled.
TEST ATMOSPHERE
- Particle size distribution: See Tables below
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The atmosphere generated in this study was considered to be respirable in rats, the mass median aerodynamic diameter was 2.0 μm ± 2.0 (MMAD ± GSD), with 97% of the aerosol being less than 10 μm MMAD. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2000 ± 560 mg/m³
- No. of animals per sex per dose:
- 5 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily cage-site examination – all animals
- Body weight: twice weekly – all animals
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- other: ALC (approximate lethal concentration)
- Effect level:
- > 2 000 mg/m³ air
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 2 000 mg/m³ air
- Exp. duration:
- 4 h
- Mortality:
- No animals died following the single acute 3G8 exposure.
- Clinical signs:
- other: No notable clinical signs of toxicity were observed during this study.
- Body weight:
- All animals demonstrated a normal weight gains (approximately 5-10 g/day) except for one rat that lost 3g and subsequently demonstrated weight gain by 2 days post-exposure.
Any other information on results incl. tables
Chamber Concentrations of 3GO (Acute Lethal Concentration Study)
MEASURED CONCENTRATION (mg/m³)* |
|||
MEAN |
S.D. |
RANGE |
n |
2000 |
560 |
1100 - 2600 |
8 |
* Represents the mean, standard deviation (S.D.), and range for the exposure, based on n samples. |
Particle Size Distribution of 3GO (Acute Lethal Concentration Study)
MEASURED CONCENTRATION |
MASS MEDIAN AERODYNAMIC |
GEOMETRIC STANDARD |
% PARTICLES BY MASS |
||
(mg/m³) |
DIAMETER (μm) |
DEVIATION |
<1 μm |
<3 μm |
<10 μm |
2000 |
2.0 |
2.0 |
15 |
73 |
97 |
Chamber Environmental Conditions (Acute Lethal Concentration Study)
MEASURED CONCENTRATION |
TEMPERATURE (°C)* |
RELATIVE HUMIDITY (%)* |
AIRFLOW (L/min)* |
|||
(mg/m³) |
RANGE |
n |
RANGE |
n |
RANGE |
n |
2000 |
24 |
3 |
46 - 50 |
3 |
16 |
4 |
* Values represent the range for all samples obtained from n samples. |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LC50 > 2000 mg/m³ air
ALC (approximate lethal concentration) > 2000 mg/m³ air - Executive summary:
One group of Crl:CD®(SD)IGS BR rats was subject to a 4-hour nose-only exposure to 2000+560 mg/m³ (mean+SD) 3G8. No notable clinical signs of toxicity were observed in animals immediately following exposure and no animals died. Under the conditions of exposure, the approximate lethal concentration (ALC) for 3G8 is greater than 2000 mg/m³ and the median lethal concentration is greater than 2000 mg/m³ air. According to the Haskel Laboratory toxicity classification, 3G8 is considered to be of very low toxicity (ALC greater than 2000 mg/m³ air) in rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.