Registration Dossier
Registration Dossier
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: 201-545-9 | CAS number: 84-61-7
- 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:
- from 7th June to 24 th June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in compliance with international recognized guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Dicyclohexyl phthalate
- EC Number:
- 201-545-9
- EC Name:
- Dicyclohexyl phthalate
- Cas Number:
- 84-61-7
- Molecular formula:
- C20H26O4
- IUPAC Name:
- 1,2-dicyclohexyl benzene-1,2-dicarboxylate
- Test material form:
- other: crystalline powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley SD
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal supply and acclimatisation
Species and strain: Rat, Sprague Dawley SD
Number and sex: Females (nulliparous and non-pregnant)
Age and weight range (at order): 6 to 7 weeks old, 150 to 174 grams
Supplier: Charles River Italia S.p.A., Calco (Lecco), Italy
Breeder: Charles River Italia S.p.A., Calco (Lecco), Italy
Date of arrival: 31 May 2012
Weight range at arrival: 160 to 171 grams
Acclimatisation period: At least 5 days
Veterinary health check: After arrival
Caging
No. of animals/cage: 3 during the study; up to 5 during acclimatisation
Housing: polisulphone solid bottomed cages measuring 42.5x26.6x18.5 cm (during acclimatisation) and 59x38.5x20 (during the study) cm with nesting material
Cage tray control: Daily inspected and changed as necessary (at least 3 times/week)
Water and diet
Water: Drinking water supplied to each cage via a water bottle
Water supply: Ad libitum
Diet: 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply: Ad libitum throughout the study except for dosing procedure indicated in section 4.2.2
Housing conditions (parameters set)
Room lighting : Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes : Approximately 15 to 20 air changes per hour
Temperature range: 22°C ± 2°C
Relative humidity range: 55% ± 15%
Actual conditions were monitored and recorded and records retained. No relevant deviations occurred.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The acute toxicity of DICYCLOHEXYL PHTHALATE was investigated following a single oral administration (10 mL/kg in corn oil) to the Sprague Dawley rat followed by a 14-day observation period.
- Doses:
- Frequency of treatment: Once only, on the day of dosing (Day 1).
Fasting procedure: Overnight prior to dosing (Day –1) up to 4 hours after dosing.
Dose calculation: Dose volume of 10 mL/kg of body weight for each animal.
Dosing method: By gavage, using a plastic feeding tube attached to a graded syringe. - No. of animals per sex per dose:
- 3 females per doses
- Control animals:
- no
- Details on study design:
- A first sub-group of 3 female animals was dosed at a level of 2000 mg/kg (Step 1). Mortality did not occur. A second sub-group, similarly composed, was then dosed at the same dose level (Step 2). No mortality occurred.
No further doses were investigated since the objective of the study had been achieved. - Statistics:
- not applocable
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in the 6 animals dosed in two sub-groups treated at 2000 mg/kg (Steps 1 and 2).
- Clinical signs:
- other: No clinical signs were recorded in the 6 animals dosed in two sub-groups treated at 2000 mg/kg (Steps 1 and 2).
- Gross pathology:
- At necropsy examination, no abnormalities were observed in any animal of the study (Steps 1 and 2).
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The acute toxicity of DICYCLOHEXYLPHTHALATE was investigated following a single oral administration (10 mL/kg in corn oil) to the Sprague Dawley rat followed by a 14-day observation period.
No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000 mg/kg.
These results indicate that the test item DICYCLOHEXYLPHTHALATE did not induce effects of toxicological relevance in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight. - Executive summary:
The acute toxicity of DICYCLOHEXYLPHTHALATE was investigated following a single oral administration to the Sprague Dawley rat. The test item (batch 031-12) was administered at 2000 mg/kg (dose volume of 10 mL/kg using corn oil as vehicle).
Animals were observed for a 14 day period, then subjected to necropsy examination.
A first sub-group of 3 female animals was initially dosed at 2000 mg/kg (Step 1). No mortality occurred and no clinical signs were observed.
A second sub-group of 3 female animals was then dosed at the same dose level (Step 2). No deaths occurred and no clinical signs were noted.
Body weight changes recorded during the study were within the expected range for this strain and age of animals.
No abnormalities were observed in any animal treated at necropsy examination performed at the end of the observation period.
These results indicate that the test item DICYCLOHEXYLPHTHALATE did not induce effects in the rat following oral administration of a single dose at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.