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EC number: 268-582-0 | CAS number: 68130-25-6
- 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:
- 6th March 2014-24th April, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- EC Number:
- 268-582-0
- EC Name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Cas Number:
- 68130-25-6
- Molecular formula:
- C10 H20 O2 . x C8 H16 O2 . x C8 H16 O2 . x C5 H12 O4
- IUPAC Name:
- Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate
- Test material form:
- liquid
- Details on test material:
- Name: ADEKA PROVER H-32
Chemical name: PENTAERYTHRITOL, 2-ETHYLHEXANOIC ACID, CAPRYLIC ACID, CAPRIC ACID MIXED ESTER
Lot No. 61893
CAS No. 68130-25-6
Appearance: Pale yellow liquid
Purity: 100%
Molecular formula: C(CH2OH)4 x C8H16O2 (2-ETHYLHEXANOIC ACID) x C10H20O2 x C8H16O2 (CAPRYLIC ACID)
Specific gravity: 0.97
Affinity: Hydrophobic, lipophilic
Stability: Stable in normal condition
Date of manufacture: Sep. 18, 2013
Expiration date: Sep. 18, 2015
Storage conditions: Normal temperature (20.8 to 21.7°C)
Date of receipt: Feb. 20, 2014
Residual test substance: The unused portion of the test substance was discarded after completion of the study.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ORIENTBIO INC., Korea
- Females (if applicable) nulliparous and non-pregnant: unknown
- Age at study initiation: 8 to 9 weeks old
- Weight at study initiation: 181.8 to 218.4 g
- Fasting period before study: Animals were fasted overnight, approximately 16 hours prior to dosing.
- Housing:Stainless wire mesh cage, 260W×350D×210H (mm)
- Diet (e.g. ad libitum): The feed was placed in feeders and provided ad libitum.
- Water (e.g. ad libitum):Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 23.5°C
- Humidity (%): 44.5 to 62.0%
- Air changes (per hr): 10 to 15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: Day 1 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): The required amount of the test substance was weighed using an electronic balance (CP323S, Sartorius, Germany) and placed in a bottle. A small amount of vehicle, corn oil, was added and mixed using a vortex mixer until dissolved. The vehicle was gradually added to yield the desired concentrations (60 and 400 mg/mL). All preparations were conducted just prior to use.
- Justification for choice of vehicle:
- Lot/batch no. (if required): MKBP7039V
MAXIMUM DOSE VOLUME APPLIED: 5ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg because there is no available toxicity information on the test substance. - Doses:
- 300mg/kg and 2000mg/kg
- No. of animals per sex per dose:
- 3 animals per dose.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs (time, onset, severity and recovery) at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Days 1 to 14). The body weights were recorded prior to dosing (Day 0), on Days 1, 3 and 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:Since no gross findings were evident at the necropsy, histopathological examinations were not performed. - Statistics:
- Statistical analysis was not performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals dosed at 300 and 2,000 mg/kg survived the duration of the study. There were no effects on the mortality.
- Clinical signs:
- other: No clinical abnormalities were evident in any animals dosed at 300 and 2,000 mg/kg.
- Gross pathology:
- No grossly visible evidence of morphologic abnormalities was evident in any animals dosed at 300 and 2,000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance, ADEKA PROVER H-32, was classified to be Category 5 or Unclassified according to the GHS classification.
- Executive summary:
The purpose of this study was to assess the potential toxicity and to classify the test substance, ADEKA PROVER H-32, under the category of GHS classification following a single oral administration to female Sprague-Dawley rats.
Three dose groups of three females per group were utilized as follows:
Groups 1 and 2 (Steps 1 and 2): 300 mg/kg of the test substance
Groups 3 and 4 (Steps 3 and 4): 2,000 mg/kg of the test substance
Step 1: 300 mg/kg was administered. Then, there was no mortality (Step 1), and a second dose of 300 mg/kg was administered (Step 2).
Step 3: There was no mortality (Steps 1 and 2), and a third dose of 2,000 mg/kg was administered. Then, there was no mortality (Step 3) and a fourth dose of 2,000 mg/kg was administered (Step 4).
All animals were monitored for clinical signs and body weight changes during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period.
There were no deaths of animals dosed at 300 and 2,000 mg/kg. No acute toxic effects were evident in clinical signs, body weight data or necropsy findings in any animals dosed at 300 and 2,000 mg/kg.
Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance, ADEKA PROVER H-32, was classified to be Category 5 or Unclassified according to the GHS classification.
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