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EC number: 230-743-8 | CAS number: 7299-99-2
- 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:
- July 14, 2014 to August 4, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- EC Number:
- 230-743-8
- EC Name:
- 2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
- Cas Number:
- 7299-99-2
- Molecular formula:
- C37H68O8
- IUPAC Name:
- 3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(2-ethylhexanoyl)oxy]methyl})propyl 2-ethylhexanoate
- Test material form:
- other: Clear, yellow liquid
- Details on test material:
- Date Received: June 16, 2014
Supplier: Chemtura Fords, New Jersey
Amount Received: Approximately 2083.33 (total of 2 containers)
Label Identification: Hatcol 3346
Batch Number: 2013059135
Physical Characteristics: Clear, yellow liquid
Retest Date: May 30, 2017
Storage: Room temperature, protected from light
TMC Number: 1405A8
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD® [Crl:CD®(SD)]
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: RatStrain: CD® [Crl:CD®(SD)]Source: Charles River LaboratoriesExpected Age: 7 weeks of age at arrivalExpected Weight at Arrival: Females weighed 100 to 170 g, as measured within 3 days of arrival. Number Ordered Female: 10Number on Study Female: Up to 9AcclimationDuration: At least 1 weekAcclimation Details: During this acclimation period, all animals were observed daily for any clinical signs of disease, and all animals were given a detailed clinical examination prior to selection for study.Selection for StudyBody Weight Range: ±20% of the mean body weightRandomization: Into treatment groups using a simple randomization procedure. All animals with any evidence of disease or physical abnormalities were not selected for study.Method of Identification: Each animal was assigned an animal number to be used in Provantis™ and was implanted with a microchip bearing a unique identification number. The individual animal number, implant number, and the MPI Research study number comprises a unique identification for each animal. The animal cage was identified by the study number, animal number, group number, and sex.Housing: IndividuallyCaging: Solid bottom cages with nonaromatic bedding. The bedding was sourced from an approved supplier and documented in the study data.Temperature: 68 to 79 °FHumidity: 30 to 70%Lighting: Fluorescent lighting was provided via an automatic timer for approximately 12 hours per day. On occasion, the dark cycle could be interrupted intermittently due to study-related activities.Water: Tap water was supplied ad libitum to all animals via an automatic water system unless otherwise indicated.Diet: The basal diet was block Lab Diet® Certified Rodent Diet #5002, PMI Nutrition International, Inc. This diet was available ad libitum unless designated otherwise. Each lot number used was identified in the study records.Water and Diet Contaminants: There are no known contaminants in the food or water that would interfere with this study. The drinking water used is monitored for specified contaminants at periodic intervals according to MPI Research SOP.Supplemental Enrichment: Animal enrichment was provided as described in MPI Research SOP.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Preparation: Test article was administered neat.Frequency: Day of administrationStorage Conditions: Room temperature
- Doses:
- Sighting Study: 2000 mg/kg. As no toxicity was noted an additional group was added at 5000 mg/kg.Main Study: 5000 mg/kg
- No. of animals per sex per dose:
- 1 female per dose in the Sighting study4 females in the main study
- Control animals:
- no
- Details on study design:
- The 2000 mg/kg dose is specified by regulatory agencies for the limit test. Any additional doses were selected to estimate the LD50.The test article was administered once on Day 1 via oral gavage to one animal. The initial dose level for the sighting study was 2000 mg/kg. Due to there being no toxicity noted, an additional animal was administered the test article at a dose level of 5000 mg/kg. The results of the sighting study determined that 5000 mg/kg was the starting dose for the main study animals. Individual doses were based on the most recent body weight measurements. The test article was administered at a dose volume of 2.08 mL/kg to the initial animal dosed in the sighting study and at a dose volume of 5.21 mL/kg for the second animal in the sighting study and for all main study animals. The animals were fasted overnight prior to test article administration and had food returned following the completion of dosing.Observations for morbidity, mortality, injury, and the availability of food and water were conducted twice daily for all animals. Observations for clinical signs were conducted on Day 1 at 30 minutes, 2, and 4 hours postdose, and daily thereafter. Body weights were measured and recorded prior to dosing on Day 1 and weekly thereafter.At study termination (Day 15), the animals were euthanized by carbon dioxide inhalation. Euthanasia was confirmed via exsanguination via severing the vena cava. Necropsy examinations were performed under procedures approved by a veterinary pathologist on all animals euthanized at the scheduled necropsy. The animals were examined carefully for external abnormalities including palpable masses. The skin was reflected from a ventral midline incision, any subcutaneous masses were identified and correlated with antemortem findings, and the abdominal, thoracic, and cranial cavities were examined. Following the evaluation, the carcasses were discarded and no tissues were saved.
- Statistics:
- No statistical analyses are required or will be performed for this study.
Results and discussion
- Preliminary study:
- The test article was administered once on Day 1 via oral gavage to one animal. The initial dose level for the sighting study was 2000 mg/kg. Due to there being no toxicity noted, an additional animal was administered the test article at a dose level of 5000 mg/kg. The results of the sighting study determined that 5000 mg/kg was the starting dose for the main study animals.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived to the scheduled necropsy.
- Clinical signs:
- other: No adverse clinical findings indicative of systemic toxicity were noted. Yellow discoloured hair was noted in the anogenital region on Day 1 at 4 hours postdose for animal number 8002. This is a common finding in an animal of this age, sex, and strain, th
- Gross pathology:
- The tissues of all animals examined at necropsy were within normal limits.
- Other findings:
- No further findings detailed in the study report.
Any other information on results incl. tables
Record of Animal Fate and Disposition – Sighting Study - FEMALE
Group, Animal Number | Fate | Day |
2000 mg/kg 8001 |
Terminal necropsy |
15 |
5000 mg/kg 8002 |
Terminal necropsy |
15 |
Record of Animal Fate and Disposition – Main Study - FEMALE
Group, Animal Number | Fate | Day |
5000 mg/kg 8003 8004 8005 8006 |
Terminal necropsy Terminal necropsy Terminal necropsy Terminal necropsy |
15 15 15 15 |
Individual Detailed Clinical Observations – Sighting Study – FEMALE
30 minute & 2 hour post dose
Group, Animal Number | Day(s) Sign Present |
2000 mg/kg 8001 No abnormalities detected |
1 |
5000 mg/kg 8002 No abnormalities detected |
1 |
Individual Detailed Clinical Observations – Sighting Study – FEMALE
4 hour post dose
Group, Animal Number | Day(s) Sign Present |
2000 mg/kg 8001 No abnormalities detected |
1 |
5000 mg/kg 8002 Hair discoloured, Yellow, Anogenital region |
1 |
Individual Detailed Clinical Observations – Sighting Study – FEMALE
Group, Animal Number | Day(s) Sign Present |
2000 mg/kg 8001 No abnormalities detected |
2 - 14 |
5000 mg/kg 8002 No abnormalities detected |
2- 14 |
Individual Detailed Clinical Observations – Main Study – FEMALE
30 minute, 2 and 4 hour post dose
Group, Animal Number | Day(s) Sign Present |
5000 mg/kg 8003 No abnormalities detected 8004 No abnormalities detected 8005 No abnormalities detected 8006 No abnormalities detected |
1 1 1 1 |
Individual Detailed Clinical Observations – Main Study – FEMALE
Group, Animal Number | Day(s) Sign Present |
5000 mg/kg 8003 No abnormalities detected 8004 No abnormalities detected 8005 No abnormalities detected 8006 No abnormalities detected |
2 – 14 2 – 14 2 – 14 2 – 14 |
Individual Body Weight Values – Sighting Study, g - FEMALE
Group, Animal Number | Study Interval (Week) | ||
1 | 2 | 3 | |
2000 mg/kg 8001 |
176 |
218 |
248 |
5000 mg/kg 8002 |
167 |
185 |
199 |
Individual Body Weight Values – Main Study, g - FEMALE
Group, Animal Number | Study Interval (Week) | ||
1 | 2 | 3 | |
5000 mg/kg 8003 8004 8005 8006 |
194 205 196 192 |
217 240 225 217 |
227 269 236 234 |
Individual Animal Data Record: Pathology – Sighting Study, FEMALE
Terminal
Group, Animal Number |
Fate | Tissue | Observations |
2000 mg/kg 8001 |
S | Macroscopic All tissues |
- within normal limits |
5000 mg/kg 8002 |
S | Macroscopic All tissues |
- within normal limits |
S – Scheduled necropsy
Individual Animal Data Record: Pathology – Main Study - FEMALE
Group, Animal Number |
Fate |
Tissue |
Observations |
5000 mg/kg | |||
8003 | S | Macroscopic All tissues |
- within normal limits |
8004 | S | Macroscopic All tissues |
- within normal limits |
8005 | S | Macroscopic All tissues |
- within normal limits |
8006 | S | Macroscopic All tissues |
- within normal limits |
S – Scheduled necropsy
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, where Hatcol 3346, was administered as a single oral dose to rats, the LD50 was greater than 5000 mg/kg.
- Executive summary:
This study was conducted for the sponsor to evaluate the potential oral acute toxicity of the test article, Hatcol 3346. This study was conducted in accordance with Standard Operating Procedures (SOPs) and the protocol as approved by the Sponsor. No protocol or SOP deviations occurred. This study was based on the Organization for Economic Cooperation and Development (OECD) Guideline 420 (2001) and the Guide for the Care and Use of Laboratory Animals, Institute of Laboratory Animal Resources, National Academy Press, Washington, D.C., 2011.
The 2000 mg/kg dose is specified by regulatory agencies for the limit test. Any additional doses were selected to estimate the LD50.
The test article was administered once on Day 1 via oral gavage to one animal. The initial dose level for the sighting study was 2000 mg/kg. Due to there being no toxicity noted, an additional animal was administered the test article at a dose level of 5000 mg/kg. The results of the sighting study determined that 5000 mg/kg was the starting dose for the main study animals. Individual doses were based on the most recent body weight measurements. The test article was administered at a dose volume of 2.08 mL/kg to the initial animal dosed in the sighting study and at a dose volume of 5.21 mL/kg for the second animal in the sighting study and for all main study animals. The animals were fasted overnight prior to test article administration and had food returned following the completion of dosing.
Observations for morbidity, mortality, injury, and the availability of food and water were conducted twice daily for all animals. Observations for clinical signs were conducted on Day 1 at 30 minutes, 2, and 4 hours postdose, and daily thereafter. Body weights were measured and recorded prior to dosing on Day 1 and weekly thereafter.
At study termination (Day 15), the animals were euthanized by carbon dioxide inhalation. Euthanasia was confirmed via exsanguination via severing the vena cava. Necropsy examinations were performed under procedures approved by a veterinary pathologist on all animals euthanized at the scheduled necropsy. The animals were examined carefully for external abnormalities including palpable masses. The skin was reflected from a ventral midline incision, any subcutaneous masses were identified and correlated with antemortem findings, and the abdominal, thoracic, and cranial cavities were examined. Following the evaluation, the carcasses were discarded and no tissues were saved.
All animals survived to the scheduled necropsy.
No adverse clinical findings indicative of systemic toxicity were noted. Yellow discoloured hair was noted in the anogenital region on Day 1 at 4 hours postdose for animal number 8002. This is a common finding in an animal of this age, sex, and strain, thus deemed not test article-related.
There were no adverse test article-related effects on body weight. Body weights were within normal range for this species.
The tissues of all animals examined at necropsy were within normal limits.
Under the conditions of this study, where Hatcol 3346, was administered as a single oral dose to rats, the LD50 was greater than 5000 mg/kg. No classification is applicable.
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