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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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation, no further information on half-life estimation
Data source
Reference
- Reference Type:
- publication
- Title:
- Phthalic acid excretion as an indicator of exposure to phthalic anhydride in the work atmosphere
- Author:
- Pfaeffli P
- Year:
- 1 986
- Bibliographic source:
- Int. Arch. Occup. Environ. Health 58, 209-216.
Materials and methods
- Study type:
- health record from industry
- Endpoint addressed:
- basic toxicokinetics
- Principles of method if other than guideline:
- no Guideline follwoed
Test material
- Reference substance name:
- Phthalic anhydride
- EC Number:
- 201-607-5
- EC Name:
- Phthalic anhydride
- Cas Number:
- 85-44-9
- Molecular formula:
- C8H4O3
- IUPAC Name:
- 1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not applicable
- Details on study design:
- 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. Samples were taken pre-shift (7:00 hours), on-shift, post-shift (15:00 hours) and in the evening and the next morning after work day. Airborne phthalic anhydride levels ranged from 0.03 to 10.5 mg/m3 (mean value, MMAD not stated), determined from personal air samples from the worker breathing zone. Urine was also taken from a control group of 22 persons not occupational exposed to phthalic anhydride. Phthalic anhydride is converted to phthalic acid in the presence of water. Phthalic acid concentration in the urine was measured after esterification with methanol by electron capture gas chromatography, and expressed in terms of urinary creatinine. Urine samples were also subjected to acid, alkaline, and enzymatic hydrolysis by beta-glucuronidase or aryl sulphatase.
Results and discussion
- Results:
- Workers occupationally exposed to atmospheric phthalic anhydride absorbed the substance with some being excreted in the urine as unconjugated phthalic acid.
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).
Half-life: approx. 14 hours
Metabolites: unconjugated phthalic acid
Applicant's summary and conclusion
- 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.
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