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Diss Factsheets
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EC number: 201-607-5 | CAS number: 85-44-9
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: occupational exposure
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation, no further information on half-life estimation
- Objective of study:
- excretion
- Principles of method if other than guideline:
- The excretion of phthalic anhydride in humans has been investigated in a study where urine samples were collected from nine subjects occupationally exposed to phthalic anhydride.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Occupational exposure, purity not specified.
- Radiolabelling:
- no
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- Occupational exposure
- Remarks:
- Doses / Concentrations:
range: 0.03-10.5 mg/m³ - No. of animals per sex per dose / concentration:
- Nine subjects
- Preliminary studies:
- No data
- Details on absorption:
- Workers occupationally exposed to atmospheric phthalic anhydride absorbed the substance with some being excreted in the urine as unconjugated phthalic acid.
- Details on distribution in tissues:
- No data
- Details on excretion:
- At low atmospheric phthalic anhydride concentrations (mean +/- SD; 0.15 +/- 0.15 mg/m3, range 0.03 - 0.33 mg/m3, n=5) the excretion of phthalic acid increased from the pre-shift (7:00 hours) concentration to the post-shift (15:00 hours) concentration and decreased then until the pre-shift concentration was again reached. The pre-shift phthalic acid concentration in the urine (0.49 +/- 0.15 µmol/mmol creatinine) were not significantly different from those of occupationally unexposed people (0.34 +/- 0.25 µmol/mmol creatinine, range 0.02-0.089 µmol/mmol creatinine, n=22). Exposure to higher concentrations of phthalic anhydride in air (1.63 +/- 0.13 mg/m3, n=2) resulted in a body load of phthalic acid which was not totally cleared overnight, and with pre-shift phthalic acid concentrations in the urine with a mean value three times the mean control value (1.02 +/- 0.25 µmol/mmol creatinine). One worker exposed to high concentration of phthalic anhydride (10.2 mg/m³) had a pre-shift urinary concentration of 4.8 µmol of phthalic acid /mmol creatinine; approximately 14 times that of the control group. The concentration of phthalic acid in the urine was found to increase from the pre-shift level to a maximum in the immediate post-shift or evening urine sample. The concentration then decreased, with a half-life of approx. 14 hours (no further information on half-life estimation).
- Key result
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: ca. 14 hours
- Metabolites identified:
- yes
- Details on metabolites:
- Unconjugated phthalic acid
- Executive summary:
The excretion of phthalic anhydride in humans has been investigated in a study where urine samples were collected from nine subjects occupationally exposed to phthalic anhydride, primarily by the inhalation route.
At low atmospheric phthalic anhydride concentrations (mean +/- SD; 0.15 +/- 0.15 mg/m³, range 0.03 - 0.33 mg/m³, n=5) the excretion of phthalic acid increased from the pre-shift (7:00 hours) concentration to the post-shift (15:00 hours) concentration and decreased then until the pre-shift concentration was again reached. The pre-shift phthalic acid concentration in the urine (0.49 +/- 0.15 µmol/mmol creatinine) were not significantly different from those of occupationally unexposed people (0.34 +/- 0.25 µmol/mmol creatinine, range 0.02-0.089 µmol/mmol creatinine, n=22). Exposure to higher concentrations of phthalic anhydride in air (1.63 +/- 0.13 mg/m³, n=2) resulted in a body load of phthalic acid which was not totally cleared overnight, and with pre-shift phthalic acid concentrations in the urine with a mean value three times the mean control value (1.02 +/- 0.25 µmol/mmol creatinine). The concentration of phthalic acid in the urine was found to increase from the pre-shift level to a maximum in the immediate post-shift or evening urine sample.
The concentration then decreased, with a half-life of approx. 14 hours.
No evidence was seen of conjugate formation.
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and well documented
- Objective of study:
- other: hydrolysis test
- Principles of method if other than guideline:
- The rate of hydrolysis of phthalic anhydride was determined at different pHs at 25°C in water/buffer containing a small amount of acetonitrile.
- GLP compliance:
- no
- Radiolabelling:
- no
- Species:
- other: not applicable - in vitro test
- Strain:
- other: not applicable - in vitro test
- Sex:
- not specified
- Route of administration:
- other: not applicable - in vitro test
- Vehicle:
- other: aqueous solution with HCl or buffer + acetonitrile
- Duration and frequency of treatment / exposure:
- Not applicable - in vitro test
- Remarks:
- Doses / Concentrations:
not applicable - in vitro test - No. of animals per sex per dose / concentration:
- Not applicable - in vitro test
- Control animals:
- other: not applicable - in vitro test
- Preliminary studies:
- no data
- Details on absorption:
- Not applicable- in vitro test
- Details on distribution in tissues:
- Not applicable - in vitro test
- Details on excretion:
- Not applicable - in vitro test
- Toxicokinetic parameters:
- half-life 2nd: not applicable - in vitro test
- Toxicokinetic parameters:
- half-life 1st: not applicable - in vitro test
- Toxicokinetic parameters:
- half-life 3rd: not applicable - in vitro test
- Metabolites identified:
- yes
- Details on metabolites:
- Phthalic anhydride hydrolyzes rapidly in the presence of water forming phthalic acid.
- Executive summary:
The rate of hydrolysis of phthalic anhydride was determined at different pHs at 25°C in water/buffer containing a small amount of acetonitrile.
Phthalic anhydride hydrolyzes rapidly in the presence of water forming phthalic acid. Half-life for phthalic anhydride was 30.5 seconds at pH 7.24. At pH 6.8 the half-life of phthtalic anhydride in water was prolonged to 61 seconds.
Referenceopen allclose all
No evidence was seen of conjugate formation.
No remarks
Description of key information
The excretion has been examined in subjects occupational exposed to phthalic anhydride. The substance was eliminated as phthalic acid. In in vitro experiments in aqueous solution the substance was also rapidly hydrolyzed to phthalic acid. No evidence was found for conjugate formation. Thus, workers occupationally exposed to atmospheric phthalic anhydride absorbed the substance with subsequent excretion in the urine as unconjugated phthalic acid (Pfaeffli, 1986).
In summary, on contact with water, phthalic anhydride is rapidly
hydrolyzed to phthalic acid. Unconjugated phthalic acid was found in the
urine of humans exposed to phthalic anhydride by the inhalation route,
demonstrating systemic absorption and elimination via the urine and the
existence of phthalic acid as the only hydrolysis product in vivo.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Phthalic anhydride is metabolized in humans to phthalic acid. No conjugate formation was observed. Partly phthalic anhydride was bound to tissue as found with radiolabelled phthalic anhydride in animal experiments, but the degree and tissues were not specified.
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