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EC number: 251-132-2 | CAS number: 32634-68-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in vitro:
Ames test:
The test chemical 2,3-bis[(4-methylbenzoyl)oxy]succinic acid did not induce gene mutation in Salmonella typhimurium strains and E. coli WP2 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- 1. Histidne for Salmonella typhimurium strains and tryptophan for E.coli strains
2. Histidine - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- 1
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Remarks:
- 1
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Remarks:
- 2
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S 9 is a 9000 × g centrifugal supernatant fraction of liver homogenate prepared by administering phenobarbital and 5,6-benzoflavone in combination with 7-week-old male SD rats
- Test concentrations with justification for top dose:
- 1.
-S9: 0, 313, 625, 1250, 2500 or 5000 µg/plate
+S9: 0, 156, 313, 625, 1250, 2500 or 5000 µg/plate
2. 6 different concentrations were used; 10.0 mg/plate was the maximum concentration - Vehicle / solvent:
- 1.
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
2.
- Vehicle(s)/solvent(s) used: Phosphate buffer
- Justification for choice of solvent/vehicle: The test chemical was soluble in phosphate buffer - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene and 2- (2-furyl) -3- (5-nitro-2-furyl) acrylamide
- Remarks:
- 1
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Phosphate buffer
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Remarks:
- 2
- Details on test system and experimental conditions:
- 1. METHOD OF APPLICATION: Preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Three plates were used for each dose in this test, and twice to confirm reproducibility
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS: No data
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data
2. METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Duplicate
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Rationale for test conditions:
- 1. No data
- Evaluation criteria:
- 1. Regardless of the presence or absence of S9 mix in any of the test strains, the number of reversed mutantcolonies (mean value) increased with the increase in the dose of the test substance to more than twice the negative (solvent) control value, When reproducibility was observed, the test substance was determined to be mutagenic (positive).
2. The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated). - Statistics:
- 1. No statistical method was used for judging the test results
2. No data - Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Remarks:
- 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Remarks:
- 1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- 1.
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: Preliminary test was carried out at 7 doses of 5000, 1250, 313, 78.1, 19.5, 4.88 and 1.22 μg / plate using
Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Escherichia coli WP 2 uvr A / pKM 101, no increase in the number of revertant colonies was observed in any of the strains. In all the strains coexisting withS9 mix, antibacterial activity was observed at 5000 μg / plate.
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data
2. ADDITIONAL INFORMATION ON CYTOTOXICITY: The maximum dose for negative results represents the highest non-cytotoxic dose used in the experiment - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical 2,3-bis[(4-methylbenzoyl)oxy]succinic acid did not induce gene mutation in Salmonella typhimurium strains and E. coli WP2 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
Data available for the test chemicals was reviewed to determine the mutagenic nature of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid. The studies are as mentioned below:
Ames assay was performed to determine the mutagenic nature of the test chemical. The study was performed by the preincubation protocol using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA / pKM101 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose level of 0, 313, 625, 1250, 2500 or 5000µg/plate in the absence of S9 and 0, 156, 313, 625, 1250, 2500 or 5000µg/plate in the presence of S9. Concurrent solvent and positive control plates were also included in the study. Based on the observations made, the test chemical did not induce gene mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA / pKM101 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 with and without S9 metabolic activation system. The test was performed as per the preincubation assay at six different concentrations with 10.0 mg/plate being the maximum concentration. The chemical was dissolved in phosphate buffer. Preincubation was performed for 20 mins and the exposure duration was for 48 hrs. The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated). The test chemical did not induce a doubling of revertant colonies over the control using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 in the presence and absence of S9 metabolic activation system and hence the chemical is not likely to classify as a gene mutant in vitro.
Based on the observations made, the test chemical 2,3-bis[(4-methylbenzoyl)oxy]succinic acid did not induce gene mutation in Salmonella typhimurium strains and E. coli WP2 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Gene mutation in vitro:
Ames test:
Data available for the test chemicals was reviewed to determine the mutagenic nature of 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (CAS no 32634 -68 -7). The studies are as mentioned below:
Ames assay was performed to determine the mutagenic nature of the test chemical. The study was performed by the preincubation protocol using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA / pKM101 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in DMSO and used at dose level of 0, 313, 625, 1250, 2500 or 5000µg/plate in the absence of S9 and 0, 156, 313, 625, 1250, 2500 or 5000µg/plate in the presence of S9. Concurrent solvent and positive control plates were also included in the study. Based on the observations made, the test chemical did not induce gene mutation in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA / pKM101 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
In another study, gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical. The study was performed using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 with and without S9 metabolic activation system. The test was performed as per the preincubation assay at six different concentrations with 10.0 mg/plate being the maximum concentration. The chemical was dissolved in phosphate buffer. Preincubation was performed for 20 mins and the exposure duration was for 48 hrs. The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated). The test chemical did not induce a doubling of revertant colonies over the control using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 in the presence and absence of S9 metabolic activation system and hence the chemical is not likely to classify as a gene mutant in vitro.
Based on the observations made, the test chemical 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (CAS no 32634 -68 -7) did not induce gene mutation in Salmonella typhimurium strains and E. coli WP2 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Based on the observations made, 2,3-bis[(4-methylbenzoyl)oxy]succinic acid (CAS no 32634 -68 -7) does nor exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
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