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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP defined; short description
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- Seven- to 8 -wk-old male ICR strain mice were subjected to the Micronucleus (MN) test. Animals were administered the test substance ip and were sacrificed 24 h after treatment. Bone marrow was extracted and numbers of micronucleated cells were determined by counting numbers of polychromatic erythrocytes (PCE) from among at least 1000 PCE per animal. Micronucleated polychromatic erythrocytes MNPCE) that contained micronuclei were counted from among at least 1000 PCE.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Phthalic acid
- EC Number:
- 201-873-2
- EC Name:
- Phthalic acid
- Cas Number:
- 88-99-3
- Molecular formula:
- C8H6O4
- IUPAC Name:
- phthalic acid
- Details on test material:
- Phthalic acid [C6H4-1,2-(COOH)2; Cas number 88-99-3]; no details about purity given.
Constituent 1
- Specific details on test material used for the study:
- Supplier: Sigma; commercial grade can be suggested
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- Animals were administered the test substance i.p. and were sacrificed 24h after treatment.
- Frequency of treatment:
- single dose
- Post exposure period:
- 24h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20, 100, 500, 2500, 12500 µM/kg)
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- Bone marrow was extracted with fetal bovine serum (0.5 ml), and cell suspensions were centrifuges at 1000xg for 5 min. Number of micronucleated cells were determined by counting numbers of polychromatic erythrocytes (PCE) from among at least 1000 PCE per animal.Micronucleated polychromatic erythrocytes (MNPCE) that contained micronuclei were counted from among at least 1000 PCE.
- Details of tissue and slide preparation:
- MMC (positive control, 2 mg/kg) dissolved in sterile deionized water
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- other: Vehicle control= negative control
- Positive controls validity:
- valid
Any other information on results incl. tables
Micronucleus Induction in Mouse Bone Marrow Cells Treated with Phthalic Acid:
Samples | Treatments | Concentrations | Route | Number of mice tested | Exposure time (h) | MNPCE%a (mean+ SD) | PCE/(PCE+NCE)b (mean+SD) |
Phthalic Acid | Controlc | 0 | i.p. | 5 | 24 | 0.24 +0.05 | 0.11 +0.02 |
20 µM/kg | i.p. | 5 | 24 | 0.32 +0.34 | 0.15 +0.04 | ||
100 µM/kg | i.p. | 5 | 24 | 0.38 +0.35 | 0.13 +0.03 | ||
500 µM/kg | i.p. | 5 | 24 | 0.41 +0.25 | 0.16 +0.05 | ||
2500 µM/kg | i.p. | 5 | 24 | 0.31 +0.55 | 0.14 +0.02 | ||
12500 µM/kg | i.p. | 5 | 24 | 0.35 +0.26 | 0.18 +0.01 | ||
MMCd | 2 mg/kg | i.p. | 5 | 24 | 6.47 +0.54 | 0.62 +0.02 |
aMicronucleated polychromatic erythrocytes/1000 polychromatic erythrocytes, bPolychromatic erythrocytes/1000 erythrocytes, cSample dilution buffer, dMitomycin C.
Applicant's summary and conclusion
- Executive summary:
In a Micronucleus Assay in ICR strain mice the animals were injected i.p.with suspensions of test compound, which were treated as follows: group 1, vehicle alone (DMSO, negative control); groups 2, 3, 4, and 5 were treated with Phthalic Acid at 5 concentration levels (20, 100, 500, 2500, or 12500 µM/kg); and group 6 was treated with MMC (positive control, 2 mg/kg) dissolved in sterile deionized water. The animals were sacrificed 24 h after i.p. administration of the test substances. Micronuclei formations due to Phthalic Acid were evaluated using mouse bone marrow at concentrations up to 12500 µM/kg after 24 h of treatment. No mortalities were observed at these levels. Frequencies of MNPCE (micronucleated polychromatic erythrocytes/1000 polychromatic erythrocytes) in the vehicle control groups were 0.14% (PA). In general, MNPCE% was little higher for mouse bone-marrow cells treated with the test agent, but no concentration-response relationship was observed. PCE/(PCE+NCE) values were also elevated in cells treated with the test agents, but again no concentration-response relationship was found.
In conclusion, the findings of the present study suggest that phthalic acid not genotoxic according to the mutagenic test utilized.
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