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EC number: 258-469-4 | CAS number: 53306-54-0
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity:
- oral: LD50 > 5000 mg/kg bw
- dermal: LD50 > 2000 mg/kg bw
- inhalative: LC50 > 5 mg/L air (4 h exposure)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 May 1979 to 6 Jun 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- weight variation is higher than 20% of mean
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sherman Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 24 h
- Diet: ad libitum
- Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 g/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No unusual behavioral signs were noted.
- Gross pathology:
- Gross pathological examination revealed nothing remarkable.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Comparable to current guideline requirements and scientifically valid with acceptable restrictions.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- exposure time was only 1 hour
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: albino rats
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: all glass exposure chamber
- Exposure chamber volume: 70 L
- System of generating particulates/aerosols: The air was passed through a desiccant prior to being passed through the test material.
- Rate of air: 10.0 L/min
- Temperature in air chamber: 70°F
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 3 - 5 µm - Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- concentration was calculated by differential weighing
- Duration of exposure:
- 1 h
- Concentrations:
- 20.5 mg/L (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 20.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: calculated according to GHS
- Mortality:
- No mortality
- Clinical signs:
- other: Immediately after exposure the animals were wet, ruffled, agitated and raspy sounding. After 24 hours they appeared normal.
- Body weight:
- Prior to study: mean 205 g (males), 200 g (females)
End of study: mean 250 g (males), 235 g (females) - Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Interpretation of results:
- GHS criteria not met
Reference
According to GHS the value for dust (aerosol) has to be divided by 4 in order to compare 1 hour exposure to a 4 h exposure as recommended in the guideline. Thus, the value would be above 5 mg/L.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 000 mg/m³ air
- Quality of whole database:
- The study was considerd as reliable for the assessment of the LC50.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- weight variation is higher than 20% of mean
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 2.0 and 3.0 kg - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of animal
- Preparation: All animals had their backs clipped free 24 h prior to testing. All of the animals had their backs abraded prior to dosing.
- Type of wrap if used: large gauze patches and an impervious wrap around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 100%
- Constant volume or concentration used: no, corrected for body weight - Duration of exposure:
- 24 h
- 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 and weighing: prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: There were no unusual behavioral signs noted.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Comparable to current guideline requirements and scientifically valid.
Additional information
Oral
Acute oral toxicity was tested in a study, where five male and five female albino Sherman-Wistar rats received an oral application of 5000 mg/kg bw of a test substance containing 91.3% di-(2-propylheptyl) phthalate and 8.7% 2-propylheptyl/4-methyl-2-propylhexyl/di-(4-methyl-2-propylhexyl)phthalate (Biosearch Inc., 1982). Prior to dosing, the rats were fasted for 24 hours and body weights were measured. After dosing, food and water were available ad libitum and daily observations were recorded for 14 days. Because no deaths and no unusual behavioral signs were observed, the LD50 for acute oral toxicity was estimated as > 5000 mg/kg bw.
Dermal
To analyze acute dermal toxicity, 2000 mg/kg of a test substance containing 91.3% di-(2-propylheptyl) phthalate and 8.7% 2-propylheptyl/4-methyl-2-propylhexyl/di-(4-methyl-2-propylhexyl)phthalate was applied to the backs of three male and three female albino rabbits (Biosearch Inc., 1982). The skin sites were previously clipped free of hair and then covered with gauze after application. 24 hours later, the dressings and excess materials were removed and for a period of 14 days, observations and mortalities were noted. Since no mortality and no unusual behavior signs were noted, the LD50 for acute dermal toxicity was determined to be > 2000 mg/kg.
By inhalation
The acute inhalation toxicity of DPHP was investigated in a group of 5 male and 5 female albino rats, which were exposed via whole-body inhalation to 20.5 mg/l di-(2-propylheptyl) phthalate aerosol (3-5 microns) of 91.3% purity [8.7% 2-propylheptyl/4-methyl-2-propylhexyl/di-(4-methyl-2-propylexyl) phthalate] for a period of one hour (Biosearch Inc., 1982). Thereby, the exposure was conducted in a 70 L all glass exposure chamber with an air flow rate of 10.0 l/min and a temperature of approximately 21 °C. During the 14 days observation period, no animals died and all gained body weight, although some clinical signs including wet and ruffled fur, agitation, and raspy sounds were noted. However, after 24 hours, the rats appeared normal. Since no mortality occurred and no abnormalities was found after pathological examinations, the LC50 was determined to be >20.5 mg/L after 1 h exposure. Following Haber’s Law, the value for the LC50 after 4 h exposure could be calculated as >5 mg/L air.
Justification for classification or non-classification
Due to the effect levels obtained in the acute toxicity studies, no classification according to GHS criteria is required.
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.
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