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EC number: 201-873-2 | CAS number: 88-99-3
- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD guideline or GLP defined
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 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The Ames Salmonella mutation test was used according to the plate incorporation procedure described by Maron and Ames (1983). Five Salmonella typhimurium strains were used: TA98, TA100, TA102; TA1535, and TA1537. This assay was performed with/without metabolic activation as an S9 mixture (Aroclor-1254 -induced rat liver homogenate). Negative and positive controls were used for each strain.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation 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:
- benzene-1,2-dicarboxylic 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, thus, commercial grade is suggested
Method
- Target gene:
- Ames Assay
Species / strain
- Species / strain / cell type:
- other: TA98, TA100, TA102, TA1535, TA 1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 (Aroclor-1254 induced rat liver homogenate)
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500; 12500 µM
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolical activation: 2-nitrofluorene (1µg per plate) for TA98, sodium azide (1.5 µg per plate) for TA100 and TA1535, mitomycin (1 µg per plate] for TA102, and acridine mutagen (1 µg per plate) for TA1537. With metabolical activation: 2-aminoant
Results and discussion
Test results
- Species / strain:
- other: TA98, TA100, TA102, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Reverse Mutation Test Results for Phthalic Acid in Salmonella typhimurium:
Compound | Concentration (µM) | S9 | TA98 | TA100 | TA102 | TA1535 | TA1537 |
Control | 0 | + | 26.8 +1.6 | 101.2 +10.6 | 261.3 +14.3 | 8 +0.6 | 4 +0.5 |
20 | + | 36.2 +1.8 | 158.6 +11.6 | 296.7 +15.4 | 13.6 +1.6 | 11.3 +1.6 | |
100 | + | 32.4 +1.5 | 148.6 +12.3 | 302.2 +16.8 | 16.2 +1.9 | 14.3 +1.4 | |
500 | + | 36.4 +2.1 | 152.9 +11.6 | 295.3 +12.5 | 14.4 +1.1 | 14.9 +1.1 | |
2500 | + | 29.7 +1.8 | 139.7 +10.3 | 297.6 +11.8 | 14.9 +1.1 | 13.7 +1.2 | |
12500 | + | 32.9 +1.5 | 154.2 +11.2 | 296.3 +10.8 | 15.3 +1.2 | 14.1 +0.9 | |
2 -AAa | 1.0 µg/plate | + | 402.3 +14.2 | 1278.5 +9.7 | 1358.2 +55.7 | 97.8 +2.8 | 75.5 +2.1 |
Control | 0 | - | 22.6 +2.5 | 114.3 +10.2 | 257.6 +9.8 | 9.2 +0.6 | 5.2 +0.6 |
20 | - | 29.3 +0.9 | 162.3 +14.3 | 286.3 +10.8 | 16.8 +1.2 | 13.5 +1.2 | |
100 | - | 35.2 +2.4 | 156.8 +11.6 | 294.5 +9.3 | 18.5 +2.1 | 16.2 +2.1 | |
500 | - | 31.8 +1.5 | 165.4 +13.6 | 300.5 +11.7 | 17.4 +1.5 | 15.8 +1.4 | |
2500 | - | 29.8 +2.4 | 159.6 +9.7 | 298.8 +10.6 | 17.6 +1.8 | 15.2 +1.6 | |
12500 | - | 33.5 +1.9 | 160.8 +10.2 | 297.6 +12.1 | 15.9 +1.3 | 13.4 +1.6 | |
SAb | 1.5 µg/plate | - | 1172 +52.3 | 103.5 +11 | |||
MMCc | 1.0 µg/plate | - | 1256.9 +75.4 | 0 | |||
ICR-191d | 1.0 µg/plate | - | 88.5 +3.2 | ||||
2 -NFe | 1.0 µg/plate | - | 386.7 +15.9 |
a2 -Aminoanthracene (2 -AA); bSodium azide (SA); cMitomycin C (MMC); dAcridine (ICR-191); e2 -Nitrofluorene (2 -NF).
Applicant's summary and conclusion
- Executive summary:
The Ames Salmonella mutation test was used according to the plate incorporation procedure described by Maron and Ames (1983). Five Salmonella typhimurium strains were used: TA98, TA100, TA102; TA1535, and TA1537. This assay was performed with/without metabolic activation as an S9 mixture (Aroclor-1254 -induced rat liver homogenate). Negative and positive controls were used for each strain. The positive controls used in the tests performed without metabolic activation were as follows: 2 -nitrofluorene (1µg/plate) for TA98, sodium azide (1.5 µg/plate) for TA100 and TA1535, mitomycin (1µg/plate) for TA102, and acridine mutagen (1µg per plate) for TA 1537. The positive control used in the test performed with metabolic activation was 2 -aminoanthracene (1 µg per plate) for all strains. Five concentrations of the test substance were examined: 0; 20; 100; 500; 2500; 12500 µM using five bacterial strains and triplicate plates per dose. A significant increase in the number of revertants was observed in the presence of the positive control compounds. Negative and strain-specific positive control values were within historical lab range, demonstrating that the test conditions were effective and that the metabolic activation system functioned properly. The test substance did not produce mutagenic activity in any of the five bacterial strains tested under any of the activation conditions examined.
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