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EC number: 202-829-5 | CAS number: 100-20-9
- 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 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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The test substance was concluded to be negative in Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537. No indications of mutagenicity were observed at any dose level in any tester strain when tested up to 10000 μg/plate in the absence or presence of S9. The assay was conducted prior to the 1997 adaptation of the current OECD 471, and did not include an E.coli WP2 or S. typhimurium TA102 tester strain. These strains are known to specifically detect certain oxidising mutagens, cross-linking agents and hydrazines that other Salmonella tester strains may not be sensitive to. However, based on the physico-chemical characteristics of the test substance, the inclusion of a fifth tester strain would not have changed the clearly negative outcome of the Ames assay. In addition, there was no indication of in vitro or in vivo mutagenicity for any other genetic toxicology endpoint.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Tested up to 10000 µg/plate with and without S9 metabolic activation in 4 Salmonella strains.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Terephthalic acid
- EC Number:
- 202-830-0
- EC Name:
- Terephthalic acid
- Cas Number:
- 100-21-0
- Molecular formula:
- C8H6O4
- IUPAC Name:
- Terephthalic acid
- Details on test material:
- - Purity: 99.99%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver homogenate (S9)
- Test concentrations with justification for top dose:
- 0, 500, 1000, 2500, 5000, 10000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Not reported
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (TA1535 -S9 and TA100 -S9); 9-aminoacridine (TA1537 -S9); 2-nitrofluorene (TA98 -S9); 2-aminoanthracene (all strains +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Treatment without activation was conducted by adding 0.1 mL of overnight culture containing the test sample and 1e8 bacteria to top agar supplemented with L-histidine, NaCl, and biotin. The components were mixed and poured onto a plate containing Davis minimal agar. Treatments with activation were conducted as those without activation except that S9 mix was added to the bacteria/top agar mixture before it was poured onto a Davis minimal agar plate. The plates were incubated at approximately 37°C for approximately 48 hours.
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 2 trials for all strains, except TA1537 which had 3 trials when tested with activation
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity of the test sample in the presence and absence of an activation system, as measured in strain TA1535, was the same as the method of application for mutagenesis except that 10e3 rather than 10e8 bacteria were used per plate and a non-limiting concentration of histidine was present. - Evaluation criteria:
- A chemical is classified as nonmutagenic if the reversion frequency is less than two times the spontaneous frequency, and if less than 0.02 revertants/nmole are observed.
- Statistics:
- Data from replicate plates within a single experiments are averaged. The highest average number of revertants that is obtained is expressed as a multiple of the control value for the sensitive strain(s). When a test sample is active, the average numbers of revertants observed before activity plateaus or decreases at the various concentrations tested are submitted to linear regression analysis. The slope of the line thus obtained is used to determine the number of revertants/nmole or µg of test sample.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- The hint of activity observed in strain TA1537 in Trial 2 in the presence of activation was not observed in other trials.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic in an Ames assay with Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, in the presence and absence of an exogenous activation system.
- Executive summary:
The test substance was evaluated for mutagenicity in Salmonella typhimurium strains TA100, TA1535, TA98, and TA100 with and without an exogenous metabolic activation system (S9). The maximum concentration tested was 10000 µg/plate. The hint of activity observed in strain TA1537 in Trial 2 in the presence of activation was not observed in other trials. In this study, the test substance was negative.
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