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EC number: 805-172-8 | CAS number: 65646-25-5
- 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:
- 23rd July 2015-25th August 2015
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- Please see "principles of method if other than guideline" section for further explanation.
- Principles of method if other than guideline:
- Due to an oversight the first sighting investigation was performed using water as the vehicle rather than corn oil as indicated by the vehicle trial. The formulation was satisfactory at 30 mg/mL, however, the error was realised at the second sighting investigation as water was unsuitable as vehicle for the higher concentration (200mg/mL) of test substance. As there is generally greater systemic availability of the test substance when formulated in water compared to corn oil, the absence of toxicity following preparation in water was considered to support escalation of the
dose level in corn oil.
Before the start of the main study it was noticed that an incorrect dose volume (20 mL/kg rather than 10 mL/kg) had been used in the sighting investigations resulting in administration of 600 and 4000 mg/kg rather than 300 and 2000 mg/kg. In the absence of toxicity at either level it was still considered appropriate for the main study to be performed at the limit dose of 2000 mg/kg. Typically the animal used for the sighting investigation counts as one of the five main study animals, however, as no animals received 2000 mg/kg during the sighting investigations the
main study was performed with five animals.
The test material container was also flushed with nitrogen after each opening. These deviations were considered to have not affected the integrity or validity of the study. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 1,2-dipropyl cyclohexane-1,2-dicarboxylate
- EC Number:
- 805-172-8
- Cas Number:
- 65646-25-5
- Molecular formula:
- C14 H24 O4
- IUPAC Name:
- 1,2-dipropyl cyclohexane-1,2-dicarboxylate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): CHP
- Physical state: Colourless Liquid
- Analytical purity: 98.6%
- Lot/batch No.:ST111209
- Expiration date of the lot/batch:31 December 2016
- Storage condition of test material:Room temperature (ca. 20°C), in the dark, under gaseous nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan®:WIST albino rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Harlan (UK) Ltd
- Age at study initiation:eight to twelve weeks of age
- Weight at study initiation:165 to 184 g
- Housing: Animals were housed inside a barriered rodent facility (Building F21, Room 044/045)
- Diet (e.g. ad libitum):Aspen chew block for environmental enrichment
- Water (e.g. ad libitum):Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 to 23°C
- Humidity (%):40 to 70%
- Air changes (per hr):The animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light):Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
IN-LIFE DATES: From: Day 1 To: Day 15
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The vehicle used on the second sighting study and the main study was corn oil.
- Doses:
- The dose levels for the study were chosen in compliance with the study guidelines. As no previous toxicological information was available the initial dose level was selected as 300 mg/kg, however, due to a calculation error the dose level administered was 600 mg/kg.
Doses in the main study was 4000mg/kg. - No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths during the sighting or main study.
- Clinical signs:
- other: Piloerection from approximately 30 minutes after dosing was observed for the sighting investigation rat receiving 4000 mg/kg. This sign was not observed from Day 3 onwards indicating recovery. There were no clinical signs observed for the sighting in
- Gross pathology:
- No abnormalities were noted in any animal (sighting or main study) at the macroscopic examination at study termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of CHP was demonstrated to be greater than 2000 mg/kg body weight.
- Executive summary:
The acute median lethal oral dose (LD50) to rats of CHP was demonstrated to be greater than 2000 mg/kg body weight.
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