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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
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- Induction of type I hypersensitivity in guinea pigs after inhalation of phthalic anhydride
- Author:
- Sarlo K, Clark ED, Ferguson J, Zeiss CR, Hatoum N
- Year:
- 1 994
- Bibliographic source:
- J. Allergy Clin. Immunol. 94, 747- 756.
Materials and methods
- Principles of method if other than guideline:
- Guinea pigs were exposed through inhalation to phthalic anhydride (PA) dust at 0.5, 1.0, and 5.0 mg/m³, 3 hours/day for 5 consecutive days. Inhalation challenge with aerosolized phthalic anhydride-guinea pig serum albumin (PA-GPSA) was performed.
- GLP compliance:
- no
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
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Test system
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 0.5, 1.0, and 5.0 mg/m³
- No. of animals per dose:
- 8 animals were exposed to 0.5 or 1.0 mg/m³
16 animals were exposed to 5.0 mg/m³
Results and discussion
- Results:
- Inhalation challenge with phthalic anhydride dust. Changes in respiratory rate were not significantly greater than the changes in respiratory rate measured in air control animals challenged with phthalic anhydride dust.
The decrease noted in plethysmograph pressure changes was not different from those measurements taken from air control animals exposed to the same concentration of phthalic anhydride dust.
Inhalation challenge with PA-GPSA conjugate One animal in the 0.5 mg/m3 group and four animals in the 5 mg/m3 group experienced significant and sustained increases in respiratory rate on challenge, as compared with the air control animals. The same animal in the 0.5 mg/m3 group, one animal in the 1 mg/m3 group, and three animals (two with significant increases in rate) in the 5.0 mg/m3 group experienced sustained respiratory reactions that resulted in significant increases in plethysmograph pressure, as compared with the air control animals.
ELISA Linear regression analysis showed a highly significant dose-response relationship (p < 0.001) for IgG antibody. Phthalic anhydride dust exposure level: Mean O.D. (±SE) at 1/100 serum dilution Air contr: 0.048 ± 0.008 0.5 mg/m3: 0.230 ± 0.071 1.0 mg/m3: 0.298 ± 0.024 5.0 mg/m3: 0.692 ± 0.1061 PCA Animals with IgG1a and IgE antibody to PA-GPSA 0.5 mg/m3: 3/8; 0/8 1.0 mg/m3: 1/8; 0/8 5.0 mg/m3: 5/8; 0/8 5.0 mg/m3: (challenged with phthalic anhydride) 1/8ND Thirty-eight percent (3 of 8) of the animals in the 0.5 mg/m3 group had measurable circulating IgG1a antibody in serum. Of these three animals, one had a significant respiratory reaction on inhalation challenge with conjugate. One of eight animals (13%) in the 1.0 mg/m3 exposure group had IgG1a antibody; this same animal had significant respiratory reactivity on conjugate challenge. Sixty-three percent (5 of 8) of the animals in the 5.0 mg/m3 exposure group had allergic antibody. All five animals experienced respiratory reactivity on conjugate challenge. None of the study animals had detectable IgE antibody to PA-GPSA. Histopathology and antibody titers Foci were observed in 8 of 8 animals in the PA dust-exposed and challenged group, with 3 of 8 having 189 foci or more (individual scores: 11, 6, 1, 365, 14, 2, 331, 189, mean value 15; mean value control group: 1). One or two lung foci were noted in 5 of 8 filtered air control/PA dust-challenged guinea pigs. No indication of hemorrhage or inflammation was noted. Alveolar hemorrhage, with accumulation of red blood cells, and a few alveolar macrophages were observed. Minimal type II cell hyperplasia was also noted.
Any other information on results incl. tables
Characterization of phthalic anhydride dust
phthalic anhydride dust exposure level: Mean analytical concentration
(mg/m3); MMAD (µm)
0.5 mg/m3: 0.55; 3.12 +/- 2.02
1.0 mg/m3: 1.27; 3.26 +/- 2.02
5.0 mg/m3: 5.57; 3.91 +/- 2.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Executive summary:
Guinea pigs were exposed through inhalation to phthalic anhydride (PA) dust at 0.5, 1.0, and 5.0 mg/m³, 3 hours/day for 5 consecutive days. Inhalation challenge with aerosolized phthalic anhydride-guinea pig serum albumin (PA-GPSA)
was performed.
Animals exposed to and challenged with 5.0 mg/m³ PA dust had significant numbers of hemorrhagic lung foci. Those animals with the greatest numberof foci had high IgG antibody activity to PA, measured by ELISA.
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