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EC number: 259-224-4 | CAS number: 54553-90-1
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
An in vitro gene mutation study in bacteria (OECD 471), an in vitro mammalian chromosome aberration test (OECD 473) and an in vitro mammalian cell gene mutation test (OECD 490) have been performed on the substance.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix based on S9 fraction from Aroclor 1254 induced male Sprague Dawley rat liver
- Test concentrations with justification for top dose:
- 0; 600; 3000; 5000 mg/l (+ S9) / 0; 50; 200; 400 mg/l (- S9)
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- CONTROLS:
The positive controls were functional.
The negative controls revealed low chromosomal aberration frequencies
(excluding gaps: 0 to 0.5 %; normal: 0 to 5 %).
PRECIPITATION CONCENTRATION: > 5000 mg/l
-------------------------------------------
MITOTIC INDEX AND CHROMOSOMAL ABERRATIONS:
-------------------------------------------
Concentration % M.I. % C.A.
-------------------------------------------
- Experiment # 1, without S9 (18 hours)
neg. control 7.0 0.0
50 mg/l 6.1 0.0
200 mg/l 7.0 0.0
400 mg/l 3.5 1.5
600 mg/l 2.2
0.03 mg/l MMC 5.2 13.0 *
-------------------------------------------
- Experiment # 1, with S9 (18 hours)
neg. control 6.8 0.5
600 mg/l 7.1 0.5
3000 mg/l 9.2 2.0
5000 mg/l 9.3 1.5
3 mg/l CP 2.5 38.0 *
-------------------------------------------
- Experiment # 2, without S9, 18 hours
neg. control 5.0 0.0
50 mg/l 4.7 1.5
200 mg/l 4.0 1.0
400 mg/l 4.8 1.0
0.03 mg/l MMC 5.4 20.5 *
-------------------------------------------
Experiment # 2, without S9, 28 hours
neg. control 7.6 0.0
400 mg/l 4.4 0.5
0.03 mg/l MMC 5.6 33.0 *
-------------------------------------------
- Experiment # 2, with S9, 18 hours
neg. control 5.3 0.5
600 mg/l 6.2 1.0
3000 mg/l 7.0 2.0
5000 mg/l 5.5 1.0
3 mg/l CP 2.0 26.5 *
-------------------------------------------
- Experiment # 2, with S9, 28 hours
neg. control 5.9 0.0
5000 mg/l 6.8 0.5
3 mg/l CP 8.2 19.5 *
-------------------------------------------
* indicates significance - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Specific details on test material used for the study:
- Batch No.: M(S)201170
Appearance/Color/State: Solid fine powder (whitish)
Content or purity: ≥99% (Nominal value)
99.50% (Measured result) - Target gene:
- Thymidine Kinase Gene
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- In this test, the L5178Y (TK+/--3.7.2C) mouse lymphoma cell, generally called L5178Y were exposed at 6 exposure concentrations including 2000, 1000, 500, 250, 125, and 62.5μg/ml cell cultures in three treatment conditions .
- Vehicle / solvent:
- The solvent (DMSO) and positive controls were included in each condition at the same time.
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Details on test system and experimental conditions:
- According to the results of the preliminary test and OECD Guideline for the Testing of Chemicals No.490 (July 29, 2016)”, the L5178Y cells will be treated at 6 doses (exposure concentration), including 2000, 1000, 500, 250, 125 and 62.5μg/ml in the treatment conditions of exposure for 3 hours with and without metabolic activation respectively and for 24 hours without metabolic activation. The concurrent solvent control (DMSO) and positive controls will be included in each treatment condition
- Evaluation criteria:
- 1) When IMF(s) in one or several doses are more than GEF* (GEF= 126×10–6), and the increase is concentration- related and/or replicated, the result is evaluated as positive.
2) The result is evaluated as negative if none of the above criteria is met.
3) In case the criteria above are not met at the same time, the repeated test should be performed using modified experimental conditions, and the biological relevance of the result should be considered. If the result is still not clear, the result is concluded to be equivocal. - Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Additional information on results:
- In this test, the results of the solvent controls and positive controls met all criteria of the test validity, so the sensitivity of the test and the efficacy of the S9 mix were validated.
The results of test item precipitate: there was no test item precipitate was observed in the cell cultures of all exposure concentrationsat at the beginning and end of the test of all the treatment condition.
The results of mutant frequency showed that the induced mutant frequencies (IMF) of all cultures exposed for 3h and 24h were consistently less than the average background mutant frequency of 126×10–6. - Conclusions:
- The result of this study is negative, so it is concluded that the test item, Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole(1:1) using the thymidine kinase gene, is non-mutagenic to the L5178Ymouse lymphoma cells under the test conditions of this study.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Batch No.: M(S)201170
Appearance/Color/State: Solid fine powder (whitish)
Content or purity: ≥99% (Nominal value); 99.50% (Measured result) - Target gene:
- histidine
- Species / strain / cell type:
- S. typhimurium TA 97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Based on the results of the preliminary test that had been performed in this lab before, six doses were selected in the first test, including 5000, 1500, 500, 150, 50 and 15 g/plate with and without metabolic activation. The validation test was conducted using the same dose levels and solvent as the first test.
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO) was used as solvent.
- Positive controls:
- yes
- Remarks:
- -CAS 140-56-7 Used in TA97a, TA98 and TA102 in S9-. -CAS 153-78-6 Used in TA97a, TA98 and TA100 in S9+ -CAS 117-10-2 Used in TA102 in S9+ -CAS 613-13-8 Used in TA1535 in S9+.
- Positive control substance:
- sodium azide
- Details on test system and experimental conditions:
- Standard plate incorporation method and the pre-incubation method at six dose levels, in triplicate, with the solvent control and positive controls, both in the presence and absence of the cofactor-supplemented S9 (S9 mix).
- Evaluation criteria:
- The test item is considered cytotoxicity if one of the below criteria is met.
1) Compared with the concurrent solvent control, the number of the revertant colonies has an obvious decrease or is absent;
2) Compared with the concurrent solvent control, the sign of the background lawn is thin or clearing.
CRITERIA OF POSITIVE RESULT
1) When there is a concentration-related increase over the range (equal to or greater than two times of that of the concurrent solvent control in TA97a, TA98, TA100, TA102 and equal to or greater than three times of that of the concurrent solvent control in TA1535) in the mean number of revertant colonies in at least one strain with or without metabolic activation system, the test item should be evaluated as positive.
2) When there is a reproducible increase (two times equal to or greater than two times of that of the concurrent solvent control in TA97a, TA98, TA100, TA102 and/or equal to or greater than three times of that of the concurrent solvent control in TA1535) at one or more concentrations in the mean number of revertant colonies in at least one strain with or without metabolic activation system, the test item should be evaluated as positive.
CRITERIA OF NEGATIVE RESULT
The test item should be evaluated as negative if none of the above criteria (See 11.7.2) is met.
CRITERIA OF EQUIVOCAL RESULT
Although most tests give clear positive or negative results, in some instances, the generated data prohibit test item from making a definite judgment. Results of this type should be reported as equivocal. - Species / strain:
- S. typhimurium, other: all tested strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see "Additional information on results"
- Additional information on results:
- In two tests, the results of the viable count showed that the density of living bacteria in the cultures of each tester strain was within the acceptable range of 0.9~9×109 colony forming units (CFU)/ml. At the same time, all results of solvent control and positive controls met the requirements of this test, so the sensitivity of the test system and the efficacy of the S9 mix were validated.
In the first test, no precipitate was observed on the surface of MGA plate inoculated with TA98 at all dose level before and after incubation, with and without metabolic activation system. In the validation test, the same results of the precipitate were observed as those in the first test.
In the first test, cytotoxicity were detected by a reduction of the backgroud lawn at the doses of 5000 and 1500g/plate without the metabolic activation in all the bacteria strains, and at the doses of 5000g/plate with the metabolic activation in TA98 and TA1535. In the validation test, the same results of the cytotoxicity were observed as those in the first test.
In the first test, with and without metabolic activation, the mean number of revertant colonies at each dose level was less than two times of that of the concurrent solvent control in TA97a, TA98, TA100, TA102 and less than three times of that of the concurrent solvent control in TA1535. In the validation test, the similar mutagenic results were obtained as those in the first test. - Conclusions:
- Under the conditions of this study, the results of the first test and the validation test were negative. Thus, the test item, Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole(1:1), was considered to be non-mutagenic in the bacterial reverse mutation test using histidine requiring tester strains of Salmonella typhimurium.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vivo:
Justification for classification or non-classification
The substance did not show genotoxic effects in an Ames tests with Salmonella typhimurium TA 97a, TA98, TA 100, TA102, TA 1535 and TA 1537 (50 -5000 microgram/plate), nor in the V79 Chinese hamster lung cell test (0 -5000 mg/l), all with and without metabolic activation.
The substance showed no genotoxic effects and there is no requirement for classification.
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