Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-008-0 | CAS number: 552-30-7
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1991-09-03 to 1991-09-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study report does not include a GLP compliance certificate and it does not indicate any specific OECD guidelines. However, the report indicates that the study was conducted according to the appropriate OECD guidelines and the study primarily followed the methodology described in the corresponding OECD guideline number 471. The methodological deficiencies identified in the report were not considered to adversely affect the validity of the study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : no indication of dose levels used in body of the report. There is no indication in the corresponding OECD guideline (471) that the strain TA1538 is appropriate to use.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : analyses to determine the uniformity, concentration, or stability of the test or control mixtures were not performed by the testing facility.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : 2-Aminoanthracene was used as the sole indicator of S-9 efficacy
- Principles of method if other than guideline:
- The methodological deficiencies were not considered to have affected the overall outcome of the study.
- GLP compliance:
- yes
- Remarks:
- : self-certified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- EC Number:
- 209-008-0
- EC Name:
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride
- Cas Number:
- 552-30-7
- Molecular formula:
- C9H4O5
- IUPAC Name:
- 1,3-dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): trimellitic anhydride
- Physical state: White flakes
- Lot/batch No.: FSF-375
- Storage condition of test material: Stored at room temperature and protected from exposure to light.
Constituent 1
Method
- Target gene:
- Histidine mutations hisG46, hisC3076, hisD3052.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: A mutation in the histidine operon. The rfa wall mutation causes a loss of one of the enzymes responsible for the synthesis part of the lipopolysaccharide layer of the cells wall. A deletion in the uvrB gene resulting in a deficient DNA excision-repair
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- other: A mutation in the histidine operon. The rfa wall mutation causes a loss of one of the enzymes responsible for the synthesis part of the lipopolysaccharide layer of the cells wall. A deletion in the uvrB gene resulting in a deficient DNA excision-repair
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 3333 and 10000 µg/plate.
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.0 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation for TA 100 and TA 1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.0 µg/plate
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation for TA 98 and TA1538
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 75 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation for TA 1538
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.0 µg/plate
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation for TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Details on test system and experimental conditions:
- The tester strains were histidine auxotrophs. They were received directly from Dr. Ames, Department of Biochemistry, University of California.
Frozen permanent stocks were prepared by growing fresh overnight cultures, adding dimethylsulfoxide and freezing 1.5 ml aliquots. The frozen permanent stocks were stored at or below 70°C. Master plates were prepared by streaking each tester strain from a frozen permanent onto minimal medium supplied with histidine and biotin, and for strains containing the R-factor, ampicillin. Master plates were stored at 4±2°C.
Overnight cultures were prepared by removing a colony of the appropriate strain from the master plate and transferring it to a vessel containing ~50 ml culture medium. The length of incubation was controlled and monitored to ensure that cultures were harvested in late log phase. Following inoculation, each flask was placed in a resting shaker/incubator at room temperature. The shaker/incubator was programmed to begin shaking at approximately 125 rpm at 37±2°C approximately 12 hours before the anticipated time of harvest. Each culture was monitored spectrophotometrically for turbidity and was harvested at a percent transmittance yielding a titre of approximately 1-2x10E9 cells/ml.
On the day of their use in the mutagenicity assay, all tester strain cultures were checked for the correct genotype. The presence of the rfa wall mutation was confirmed by demonstration of sensitivity to UV light. The presence of the pKM101 plasmid was confirmed by demonstration of resistance to ampicillin. Spontaneous reversion frequencies in the vehicle controls were demonstrated by plating 100 µl aliquots along with the appropriate vehicle on selective media.
Dosing solutions were not adjusted to compensate for the purity of the test substance. A dose range-finding study was conducted, the maximum dose tested was 10000 µg/plate.
Revertant colonies were counted either by automated colony counter or by hand. - Evaluation criteria:
- A test article was considered positive if it caused a dose-related increase in the mean revertants per plate of at least one strain with a minimum of two increasing concentrations.
- Statistics:
- Formal statistical analysis were not carried out; the mean revertants per plate and the standard deviation was calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In the dose range-finding study, the maximum dose tested (10000 µg/plate) did not precipitate, but toxicity was observed. This dose was chosen as the top dose for the mutagenicity study.
In the mutagenicity assays, for tester strains TA 98, TA 1535 and TA 1538, no positive responses were observed in the presence of microsomal enzymes and with any of the tester strains in the absence of microsomal enzymes. A 2.0 fold, non-dose responsive increase was observed with tester strain TA 1538 in the absence of microsomal enzymes. However, non-dose responsive increases are not evaluated as positive. No positive response was observed with tester strain TA 100 in the presence of microsomal enzymes. No positive response was observed with tester strain TA 1537 in the presence of microsomal enzymes.
In the confirmatory assay, no positive responses were observed with any of the tester strains in the presence and absence of microsomal enzymes. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No increase in the numbers of revertant colonies were seen following exposure to the test material.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the conditions of this study, trimellitic anhydride did not cause a positive response with any of the tester strains in the presence and absence of microsomal enzymes. - Executive summary:
Trimellitic anhydride was assessed for mutagenicity using Salmonella tester strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of rat liver microsomal enzymes using the plate incorporation technique. A dose range-finding study was conducted to establish the dose range to be used in the mutagenicity and confirmatory assays.
Based on the results of the dose-range finding study, the maximum dose tested in the mutagenicity and confirmatory assays was 10000 µg per plate. No increase in the numbers of revertant colonies were seen following exposure to the test material. Appropriate positive control compounds confirmed the sensitivity of the assay.
The results of this assay indicate that under the conditions of this study, the test article did not cause a positive response in the Salmonella/Mammalian-Microsome Plate Incorporation Mutagenicity Assay.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.