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EC number: 205-634-3 | CAS number: 144-62-7
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July, 19 2016 to January 31 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell transformation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:OXAQUIM S.A / 15000900
- Expiration date of the lot/batch: May 20, 2017
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No - Target gene:
- HPRT
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Tissue: lung
Cell type: adherent
CELLS USED
- Source of cells: National Centre for Cell Science, Pune, INDIA
- Suitability of cells: Yes
- Cell cycle length, doubling time or proliferation index: 13-16 hours
- Methods for maintenance in cell culture if applicable:DMEM medium
- Modal number of chromosomes: 22 (±3)
MEDIA USED
- Type and identity of media including CO2 concentration if applicable:DMEM
- Properly maintained: [yes/no] YES
- Periodically checked for Mycoplasma contamination: [yes/no] YES
- Periodically checked for karyotype stability: [yes/no) YES
- Periodically 'cleansed' against high spontaneous background: [yes/no] HAT Treated - Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor induced rat liver S9
- Test concentrations with justification for top dose:
- Concentrations selected:
62.5, 125, 250 and 500 ug/L
The highest dose was chosen for the cytotoxicity experiment, based on the solubility and precipitation properties of the test item - Vehicle / solvent:
- Vehicle, solvent used: DMSO
Justification: test item soluble in DMSO - Untreated negative controls:
- yes
- Remarks:
- DMEM
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
DURATION
- Preincubation period: 24 hours
- Exposure duration: 4 hours
- Expression time (cells in growth medium): 7 days
- Selection time (if incubation with a selection agent): 7 days
SELECTION AGENT (mutation assays):6-thioguanine
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 1.5x10^6 (single culture) and 5x10^2 (in duplicate) were seeded in DMEM10 for determination of mutation rate and toxicity
DETERMINATION OF CYTOTOXICITY
cloning efficiency; relative total growth; - Evaluation criteria:
- A mutation assay is considered acceptable if it meets the following criteria:
- all the negative and positive control data values falls within the historical data
- Two experimental conditions (with and without metabolic activation) were tested
A test item ei classified as positive if:
- at least one of the test concentrations exhibits a statiscally significant increase compared with the concurrent negative control
- the increase in concentration-related
Any of the results are outside the distribution of the historical negative data - Statistics:
- The number of mutant clolnies obtanined for the groups treated with the test item was compared to the solvent control groups using Mann-Whitney test. A trend is judged as significant whenever the p-value (probability value) is below 0.5. However, both, biological relevance and statictical significance was considered together
- Key result
- 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
- Remarks:
- DMSO
- Untreated negative controls validity:
- valid
- Remarks:
- DMEM Medium
- Positive controls validity:
- valid
- Remarks:
- -S9 Ethyl methanesulfonate, +S9 7, 12 Dimethyl benz(a)anthracene
- Conclusions:
- Conclusion
During the mutagenicity test described and under the experimental conditions reported the test item did not induce mutations in the HPRT locus in V79 cells of the Chinese hamster in the absence and presence of metabolic activation.
Therefore, OXALIC ACID is considered “ non-mutagenic” in this HPRT assay. - Executive summary:
This study was conducted to investigate the potential of OXALIC ACID to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. The methods followed were as per OECD guideline No. 476, adopted on 28th July 2015.
The assay was performed in a independent experiment, using two parallel cultures each. The experiment I was performed with and without liver microsomal activation at a treatment period of 4 hours. Experiment II was performed for a treatment period of 4 hours with and 24 hours with out metabolic activation.
500 µg/mL concentration was chosen as the highest dose for the cytotoxicity experiment, based on the solubility and precipitation properties of the test item.
The following concentrations were selected for both Phase - I and Phase - II based on cytotoxicity results.
500 µg/mL, 250 µg/mL, 125 µg/mL, 62.5 µg/mL both in the presence and absence of metabolic activation
No relevant cytotoxic effect as indicated by the relative survival (RS) is cloning efficiency (CE) of cells plated immediately after treatment, adjusted by any loss of cells during treatment, based on cell count and as compared with adjusted cloning efficiency in negative controls (assigned a survival of 100%). The RS for the test item in the other tested concentrations were found to be more than 50% and hence the same doses were selected for the main experiment (Phase-I and Phase-II).
PHASE-I
In culture I, the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (EMS) were 7.5, 8.7, 8.8, 12.9, 17.5, 23.8 and 152.1/106 cells respectively in the absence of metabolic activation and the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (DMBA) were 4.3, 10.3, 11.7, 15.6, 24.7, 28.1 and 1181.2 per 106 cells in presence of metabolic activation.
In culture II, the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (EMS) were 5.8, 9.5, 14.5, 15.7, 17.2, 26.9 and 169.9/106 cells respectively and in the absence of metabolic activation and the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (DMBA) were 9.3, 12.8, 17.6, 17.8, 24.7, 28.7 and 1387.6 per 106 cells in presence of metabolic activation.
PHASE-II
In culture I, the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (EMS) were 6.6, 6.9, 7.8, 9.9, 15.7, 20.9 and 170.6/106 cells respectively in the absence of metabolic activation and the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (DMBA) were 5.2, 6.7, 10.2, 15.1, 19.0, 23.2 and 1022/106 cells in presence of metabolic activation.
In culture II, the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (EMS) were 6.0, 7.5, 10.0, 13.3, 17.4, 23.7 and 155.2/106 cells respectively and in the absence of metabolic activation and the numbers of mutant colonies of NC, VC, T1, T2, T3, T4 and PC (DMBA) were 7.4, 10.7, 12.5, 17.3, 22.1, 25.2 and 1211.6 per 106 cells respectively in presence of metabolic activation.
In both the cultures, there was no distinct increase in the mutant frequency of OXALIC ACID when compared to respective vehicle control and the induction factor not exceeds more than three times the corresponding vehicle controls. No significant and reproducible dose dependent increase in mutant colony numbers was observed in either the Phase I or Phase II of the experiment.
The positive controls used, EMS in the absence of metabolic activation and DMBA in the presence of metabolic activation, revealed significant increase in mutant colonies and induction factor is more than three times of vehicle control indicating that the test system were sensitive and the results are valid
Note: NC: Negative control; VC: Vehicle control; T1: Test concentration1; T2: Test concentration 2; T3: Test concentration 3; T4: Test concentration 4; PC: Positive Control, EMS (ethyl methanesulfonate), DMBA (Dimethyl benz(a)anthracene)
Reference
See the result tables attached in "attached background material" field
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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