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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 608-319-2 | CAS number: 29126-51-0
- 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
Genetic Toxicity Bacterial Reverse Mutation Assay- Not Mutagenic to Salmonella Typhimurium bacterial Strains TA98, TA100, TA102, TA1535 and TA1537 (OECD TG 471)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003/10/22 - 2003/11/7
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ExxonMobil Research and Engineering (Paulsboro, New Jersey)
- Expiration date of the lot/batch: July 2008
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
-Physical State: white powder
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Test substance was soluble in distilled water at 250 mg/mL and was stable throughout duration of assay.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Adjustments were not made for the purity of the test substance. The test substance, as received, was considered "pure".
- Final dilution of a dissolved solid, stock liquid or gel: 100 uL of appropriate test substance dilution was added to test system containing 2 mL of molten top agar
- Final preparation of a solid: Test substance was diluted in distilled water to desired concentrations. - Target gene:
- Each S. typhimurium tester strain contains, in addition to a mutation in the histidine operon, additional mutations that enhance sensitivity to some mutagens. The rfa mutation results in a cell wall deficiency that increases the permeability of the cell to certain classes of chemicals such as those containing large ring systems that would otherwise be excluded. The deletion in the uvrB gene results in a deficient DNA excision-repair system. Tester strains TA98, TA100, and TA 102 also contain the pKM101 plasmid (carrying the R-factor). It has been suggested that the plasmid increases sensitivity to mutagens by modifying an existing bacterial DNA repair polymerase complex involved with the mismatch-repair process.
TA98 and TA1537 are reverted from histidine dependence (auxotrophy) to histidine independence (prototrophy) by frameshift mutagens. TA100 is reverted by both frameshift and base substitution mutagens and TA1535 and TA 102 are reverted only by mutagens that cause base substitutions. - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Homogenate from liver of Arochlor 1254 pretreated Sprague Dawley Rats
- Test concentrations with justification for top dose:
- Rangefinding toxicity test (TA100) 0.5, 1, 5, 10, 50, 100, 500, 1000, 2000, 2500 microgram/plate (+S9 and -S9). No signs of toxicity were observed up to the highest dose tested.
Main tests: 25, 80, 250, 800, and 2500 microgram/plate (+S9 and -S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Lab supplied reagent grade water for the test substance and positive control Mitomycin C (initial assay); Distilled water for test substance and positive control Mitomycin C (repeat assay); Dimethylsulfoxide for all positive controls except Mitomycin C.
- Justification for choice of solvent/vehicle: Materials were soluble in respective vehicles throughout duration of study - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- other: 2-Aminoanthracene: 2.5 micrograms/plate with S9
- Remarks:
- Strain TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- other: 2-Aminoanthracene 2.5 micrograms per plate without S9; Danthron 30 micrograms per plate with S9
- Remarks:
- Strain TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (+S9) and Water (-S9)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene 2.5 micrograms per plate with S9; N-Methyl-N-Nitro-N-Nitrosoguanidine 2.5 micrograms per plate without S9
- Remarks:
- Strain TA102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene 2.5 micrograms per plate with S9; N-Methyl-N-Nitro-N-Nitrosoguanidine 2.5 micrograms per plate without S9
- Remarks:
- Strain TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene 2.5 micrograms per plate with S9; 9-Aminoanthracene 100 micrograms per plate without S9
- Remarks:
- Strain TA1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: Triplicate plating
DETERMINATION OF CYTOTOXICITY
- Method: The revertant colonies were counted manually or automatically with the Q Count Colony Counter. Evidence of test article precipitate on the plates and the condition of the bacterial background lawn were evaluated when considered necessary, macroscopically and/or microscopically by using a dissecting microscope.To determine the toxicity, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed.
METABOLIC ACTIVATION SYSTEM
Rat liver microsomal enzymes (S9 homogenate) were obtained from Molecular Toxicology Inc., Boone, NC. and were prepared from male Sprague Dawley rats that had been pretreated with Aroclor 1254. The S9 used in this study was tested by the manufacturer for its ability to activate an S9 dependent mutagen. The S9 was found to be acceptable for use in mutation tests.
PREPARATION OF S9
The S9 was stored at <-70oC until just prior to use. The rat S9 mix was prepared the day of dosing and was stored on ice until used. S9-mix contained per 80 mL: 3.2 mL of 0.1M NADP; 0.4 mL of 1.0M Glucose-6-phosphate; 40 mL 0.2 M sodium phosphate buffer pH 7.4; 1.6 mL 0.4 M MgCl2 and 1.65 M KCl solution; 26.8 mL reagent grade water; and 8.0 mL S9-fraction (10% (v/v) S9-fraction).
TEST SYSTEM
Test System: Salmonella typhimurium bacteria
Rationale: Recommended test system in international guidelines (e.g. OECD, EC).
Source: Molecular Toxicology Inc. (Moltox), Boone, NC.
Salmonella typhimuriumstrains were as follows:
Strain - Histidine mutation - Mutation type
TA1537 -hisC3076 - Frameshift mutations
TA98 -hisD3052/R-factor* - Frameshift mutations
TA1535 -hisG46 - Base-pair substitutions
TA100 -hisG46/R-factor* - Base-pair substitutions and Frameshift mutations
TA102- hisG428/R-factor* - Base-pair Substitution (Ochre mutation)
*: R-factor = plasmid pKM101 (increases error-prone DNA repair)
The strains were characterized by Moltox in accordance with published procedures of Maron and Ames, 1983.
PREPARATION OF BACTERIAL CULTURES
Frozen tester strains were thawed and inoculated into a nutrient broth culture one day prior to dosing and incubated at 37±20C for 10 hours. The number of cells per culture, following a 10 hour incubation, was determined to be 1.4 x109cells/mL in the initial assay and 1.0 x109cells/mL in the repeat assay.
ADMINISTRATION OF TEST SUBSTANCE VEHICLE AND POSITIVE CONTROLS
Samples of bacteria (0.1 mL), followed by vehicle (100 microL), appropriate test substance dilution (100 microL), appropriate positive control vehicle (100 microL) or appropriate positive control substance dilution (100 microL), and 0.5 mL of S9 mix (+S9) or saline (-S9), were added to sterile glass test tubes containing 2 mL of molten top agar. The mixture was vortexed and immediately poured on plates containing a layer of minimal agar medium. After the top agar solidified, the plates were inverted and incubated at 37±2 degrees C for 48 hours. - Rationale for test conditions:
- The tester strains were exposed to the test article via the plate incorporation methodology originally described by Ames et al (1975) and Maron and Ames (1983). This methodology has been shown to detect a wide range of classes of chemical mutagens.
- Evaluation criteria:
- For tester strains TA98, TA1535, and TA1537, an individual dose was considered positive if the mean revertant colony count on the test plates was equal to or greater than three times the mean number of spontaneous revertants on the vehicle control plates. For tester strains TA100 and TA102, an individual dose was considered positive if the mean revertant colony count on the test plates was equal to or greater than two times the mean number of spontaneous revertants on the vehicle control plates. A positive result for the assay was defined as a dose-related increase in the mean number of revertant colonies over at least three concentrations of test substance, including at least one positive dose.
A lack of a positive response in the positive controls would render that portion of the test invalid. Toxicity was defined as a notable reduction in the background lawn and/or a greater than 50% reduction in the mean number of revertant colonies when compared to the vehicle control. When the mean revertant colony countfor a test substance concentration is greater than or equal to two or three times the vehicle control, toxicity may also be defined as a greater than 50% reduction in the mean number of revertant colonies at concentrations higher than the concentration that induced the largest increase in revertant colonies. - Statistics:
- The mean revertant colony count and standard deviation were determined for each dose point.
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- both initial and repeat assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- both initial and repeat assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- both initial and repeat assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- both initial and repeat assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- both initial and repeat assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- All bacterial strains showed negative responses over the entire dose range, i.e. no significant dose-related increase in the number of revertants in two independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
- Conclusions:
- The in vitro Bacterial Reverse Mutation Assay to assess the genotoxicity of dilithium glutarate was negative. This finding does not warrant the classification of dilithium glutarate as a genotoxin under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
Dilithium glutarate was examined for its potential to induce mutations in Salmonella typhimurium bacterial cells, in both the presence and absence of an S9 metabolic activation system. Two separate bacterial reverse mutation assays were performed with identical doses for each test: 25, 80, 250, 800, or 2500 ug/plate. Dilithium glutarate did not induce a statistically significant increase in the number of revertant cells at any of the doses chosen with or without metabolic activation. Under the conditions in this study, dilithium glutarate was not mutagenic to Salmonella typhimurium bacterial cells. This finding does not warrant the classification of dilithium glutarate as a genotoxin under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Dilithium glutarate was examined for its potential to induce mutations in Salmonella typhimurium bacterial cells, in both the presence and absence of an S9 metabolic activation system. Mutagenic properties have not been demonstrated and classification is not warranted.
Justification for classification or non-classification
Dilithium glutarate was not mutagenic to Salmonella typhimurium bacterial cells in a reverse mutation assay. This finding does not warrant the classification of dilithium glutarate as a genotoxin under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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.