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EC number: 238-925-9 | CAS number: 14858-73-2
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-01-23 to 2002-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 22 March 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- amended Directive (96/54/EEC) dated 30 September 1996, Annex IVB
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2-ethylhexyl) carbonate
- EC Number:
- 238-925-9
- EC Name:
- Bis(2-ethylhexyl) carbonate
- Cas Number:
- 14858-73-2
- Molecular formula:
- C17H34O3
- IUPAC Name:
- bis(2-ethylhexyl) carbonate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: males: 246 - 270 g; females: 163 - 167 g
- Fasting period before study: Fasted from 16 h before until 3-4 h after the administration of the test article. Water was available ad libitum during this period.
- Housing: housed collectively at 3 animals per cage (Makrolon® III)
- Diet: ad libitum, standard laboratory rat diet Teklad Global 18 % Protein Rodent Diet (pelleted diet, batch no.: H141) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England
- Water: ad libitum, tap water as for human consumption
- Acclimation period: 7 days (females); 9 days (males)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 16
- Photoperiod (hrs dark / hrs light): Artificial light was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: applied undiluted
MAXIMUM DOSE VOLUME APPLIED: Since the density of the liquid test article was determined as 0.89 g/ml, the test article was administered at a volume of 2.25 ml/kg body weight which corresponded to a dose of 2000 mg/kg bw.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The test was carried out in one step in 3 female and 3 male animals. Initially, the dose of 2000 mg/kg bw was administered to 3 female rats. Since no mortality was observed within 48 hours, the test article was administered subsequently to 3 male rats at the same dose of 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- 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 : In each animal a number of clinical-toxicological signs were evaluated according to a modified IRWIN Screening procedure and observed findings were recorded. The animals were examined during 10 min after dosing and at the following post-treatment intervals: 1 h, 2 h, 6 h, 24 h and thereafter once daily up to day 14.
- Frequency of weighing: Body weights were recorded immediately before treatment and on days 7 and 14 p.a. (termination).
- Necropsy of survivors performed: yes - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: approx. 100 % a.i.; no animal died
- Mortality:
- 0/6 - No animal died during the course of the 14-day observation period following the orally administered dose of 2000 mg/kg bw.
- Clinical signs:
- other: No clinical signs were observed during the 14-day observation period.
- Gross pathology:
- Gross pathological examinations on day 14 p.a. (terminal necropsy) did not reveal abnormal macroscopic findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- On the basis of the results obtained after a single oral administration in rats, the oral LD50 of Bis(2-ethylhexyl) carbonate was determined to be > 2000 mg/kg bw. No significant clinical signs, changes in body weight or gross pathological findings were observed.
- Executive summary:
In an acute oral toxicity study according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) dated 30 September 1996 and OECD Guideline 423, 22 March 1997, 3 male and 3 female young adult Wistar rats were given a single oral dose of Bis(2-ethylhexyl) carbonate, approx. 100 % a.i.) at a dose of 2000 mg/kg bw (limit test) and observed for 14 days.
Oral LD50 Males and Females > 2000 mg/kg bw
No animal died during the course of the 14-day observation period following the dose of 2000 mg/kg bw.
No clinical signs were observed.
There was no influence of the treatment on the body weight development in all male and female animals during the 14-day observation period.
Gross pathological examinations on day 14 p.a. did not reveal any finding.
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