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EC number: 208-534-8 | CAS number: 532-32-1
- 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
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- Flash point
- Auto flammability
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- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
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- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited data available on methods and results, no guidelines and no GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene in S. typhimurium
Tryptophan gene in E. coli - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate.
- Vehicle / solvent:
- 0.067M potassium or sodium phosphate buffer (pH 7.0)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Remarks:
- In the presence of S9 mix for all strains.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- In the absence of S9 mix for strains TA 98 and TA 1538.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- In the absence of S9 mix for strains TA100 and TA1535.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- In the absence of S9 mix for strain TA1537.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- furylfuramide
- Remarks:
- In the absence of S9 mix for strain E. coli WP2.
Migrated to IUCLID6: or N-methyl-N'-nitro-N-nitrosoguanidine - Details on test system and experimental conditions:
- The standard S. typhimurium plate-incorporation assay was performed in the presence and in the absence of S9 mix, contained 10% Aroclor 1254 induced liver S9 from male Sprague-Dawley rats. The E. coli test was performed by the same procedure as the S. typhimurium assay except that each liter of base agar was supplemented with 10 ml (1% v/v) of Oxoid nutrient broth to provide a trace of tryptophan.
- Evaluation criteria:
- Test results were considered valid only if the positive control compounds induced increases in mutant counts to at least twice background.
- Statistics:
- None stated.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with and without S9
Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results, no guidelines and no GLP. - Executive summary:
Reverse mutation assays using S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 were carried out with and without metabolic activation system of S9 mix. The test was performed using doses of 0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate. All platings were performed in duplicate and concurrent positive controls were run with the test.
The negative result indicated that the test substance was not mutagenic in any tested S. typhimurium and E. coli strains with or without metabolic activation.
Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results, no guidelines and no GLP.
Reference
Genetic toxicity in vivo
Description of key information
Genetic toxicity in vitro:
The reverse mutation assays were negative. Most of chromosome aberration assays (except one equivocal and one negative result) and sister chromosome exchange assays (except one equivocal result) were positive.
Genetic toxicity in vivo:
All the in vivo genotoxicity tests were negative.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predates approved guidelines and GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- number of metaphases counted
- Principles of method if other than guideline:
- Study predates approved guidelines.
This in vivo chromosome aberration study was conducted using rats. In acute study, animals were killed 6 hours, 24 hours and 48 hours after administration. In subacute study, five doses 24 hours apart, animals were killed 6 hours after last dose. Four hours af ter the last compound administration, and two hours prior to killing, each animal was given 4 mg/kg of colcemid. The chromosomes of bonemarrow cells were counted and only diploid cells were analyzed. Fifty metaphase spreads were scored per animal. Mitotic indices were obtained by counting at least 500 cells. - GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A closed colony (random-bred)
- Age at study initiation: 10 to 12 weeks old
- Weight at study initiation: 280 to 350 g
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: Housed one to five to a cage, sanitary cages and bedding were used.
- Diet (e.g. ad libitum): Commercial 4% fat diet and provided ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days - Route of administration:
- oral: gavage
- Vehicle:
- 0.85% saline
- Duration of treatment / exposure:
- Acute study: Immediately
Subacute study: 96h - Frequency of treatment:
- Acute study: Single dose
Subacute study: Once a day for each of five consecutive days - Post exposure period:
- Acute study: 6 h, 24h and 48h
Subacute study: 6h - Remarks:
- Doses / Concentrations:
50, 500 and 5000 mg/kg
Basis:
actual ingested - No. of animals per sex per dose:
- 5 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylene Melamine
- Doses / concentrations: 0.3 mg/kg - Tissues and cell types examined:
- The chromosomes of each bonemarrow cell were counted and only diploid cells were analyzed. They were scored for chromatid gaps and breaks, chromosome gaps and breaks, reunions, cells with greater than ten aberrations, polyploidy, pulverization, and any other chromosomal aberrations which were observed. Fifty metaphase spreads were scored per animal . Mitotic indices were obtained by counting at least 500 cells and the ratio of the number of cells in mitosis/the number of cells observed was expressed as the mitotic index.
- Details of tissue and slide preparation:
- The slides were stained using a 5% Giemsa solution (Giemsa buffer pH 7.2) for 20 minutes, rinsed in acetone, 1:1 acetone:xylene, and placed in fresh xylene for 30 minutes. The slides were then mounted using Permount (Fisher Scientific) and 24 x 50 mm coverglasses. The coverglasses were selected to be 0.17 mm±0.005 mm in thickness by use of a coverglass micrometer.
- Evaluation criteria:
- None stated
- Statistics:
- None stated
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Acute study:
The mitotic index in treatment groups and negative controls was similar. No increase in the number of aberrations was reported in the treated groups at all time points compared to untreated controls.
The positive control showed a lower mitotic index and a high incidence of chromosomal abnormalities
Subacute study:
The mitotic index in treatment groups and negative controls was similar. No increase in the number of aberrations was reported in the treated groups compared to untreated controls.
No data on positive controls are available. - Conclusions:
- Interpretation of results (migrated information): negative
The test substance produced no detectable significant increase in the number of aberrations in bone marrow metaphase chromosomes of rats administered orally at the dosage levels employed in this study.
Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results. Study predates approved guidelines and GLP. - Executive summary:
This in vivo chromosome aberration study was conducted using rats. In acute study, animals were killed 6 hours, 24 hours and 48 hours after administration. In subacute study, five doses 24 hours apart, animals were killed 6 hours after last dose. Four hours af ter the last compound administration, and two hours prior to killing, each animal was given 4 mg/kg of colcemid. Bonemarrow cells were harvested and the chromosomes of each cell were counted and only diploid cells were analyzed (50 metaphases per treatment).
The test substance produced no detectable significant increase in the number of aberrations in bone marrow metaphase chromosomes of rats administered orally at the dosage levels employed in this study.
Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results. Study predates approved guidelines and GLP.
Reference
No report on bodyweights, clinical findings or pathology
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vivo:
The test substance does not induce mutations in the assays with Salmonella typhimurium and Escherichia coli with and without metabolic activation (Ishidate et al. 1984, Prival et al. 1991)
The test substance did induce chromosomal damage in in vitro studies on chromosomal aberrations, sister chromatid exchange and formation of micronuclei with and without metabolic activation. The studies included both Chinese Hamster cells as well as human lymphocytes (Fabrizio 1974, Ishidate et al. 1977 and 1984, Abe et al. 1977, Mpountoukas et al. 2008, Zengin et al. 2011). For some of these assays, however, it was not clear whether effects were found at concentrations that exhibited cytotoxicity, because of the limited data that were available in the older publicatons. More recent publications (Mpountoukas et al 2008 and Zengin et. al. 2011) confirm the positive results of the older studies.
The test substance showed to be negative in a dominant lethal study, in an in vivo chromosome aberration test and a host mediated assay (Fabrizio 1974)
Based on the information in this dossier, it is concluded that the test substance, although capable of inducing chromosomal damage in vitro, is not mutagenic or clastogenic in vivo. This is further supported by the negative outcome of carcinogenicity studies in both rats and mice.
Summary of in vitro mutagenetic studies
Method/ Guideline |
Test system (Organism, strain) |
Concentrations tested (giver range) |
Results |
Remarks give information on cytotoxicity and other |
Reference |
|
+ S9 |
- S9 |
|||||
Reverse mutation assays in bacteria (all studies are non-GLP) |
||||||
Reverse mutation assay, sim. to OECD 471 |
S. typh TA 1535, 1537, 98, 100, 92 and 94 |
Maximum concentration = 3.0 mg/plate |
negative |
negative |
The test substance dissolved in distilled water |
Ishidate M., Jr, Sofuni T., Yoshikawa K., Hayashi M., Nohmi T. , Sawada M. and Matsuoka A. Fd Chem. Toxic., 22(8), 623-636 |
Reverse mutation assay, sim. to OECD 471
|
S. typh TA 1535, 1537, 98, 100, 1538, and E. coli WP2 |
0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate. |
negative |
negative |
The test substance dissolved in0.067M potassium or sodium phosphate buffer (pH 7.0) |
Prival Michael J., Simmon Vincent F. and Mortelmans Kristien E., Mutation Res., 260, 321-329 |
Chromosome aberration tests in mammalian cells in vitro (all studies are non-GLP) |
||||||
Chromosome aberration test
|
Human embryonic lung cultures |
2.0, 20.0, 200.0 mg/mL |
N/A |
negative |
The test substance dissolved in 0.85% saline. |
Fabrizio D.P.A., National Technical Information Service, PB 245453 |
Chromosome aberration test
|
Chinese hamster fibroblast cell line (CHL) |
Max. 2.00 mg/mL |
N/A |
Positive |
The test substance dissolved in Physiological saline. |
Ishidate M., Jr. and Odashima S., Mutation Research, 48 (1977) 337-354 |
Chromosome aberration test,Sim. to OECD 473 |
Chinese hamster fibroblast cell line (CHL) |
Maximum concentration = 2 mg/plate |
N/A |
Positive |
The test substance dissolved in Physiological saline |
Ishidate M., Jr, Sofuni T., Yoshikawa K., Hayashi M., Nohmi T. , Sawada M. and Matsuoka A., Fd Chem. Toxic., 22(8), 623-636 |
Chromosome aberration test, Sim. to OECD 473 |
Human peripheral lymphocytes |
6.25, 12.5, 25, 50 and 100 µg/mL |
N/A |
Positive |
The test substance dissolved in distilled water |
Zengin N., Yüzbasıog˘lu D.,ünal F., Yılmaz S., Aksoy H., Food and Chemical Toxicology 49 (2011) 763-769 |
Chromosome aberration test |
Chinese hamster cell line (Don) |
0.001, 0.002, 0.005 and 0.01 M/plate |
N/A |
ambiguous |
The test substance dissolved in HBSS |
Abe, S. & Sasaki, M., J. Nat. Cancer Inst. 58, 1635-1641 |
Chromosome aberration test, Sim. to OECD 487 |
Human peripheral lymphocytes |
6.25, 12.5, 25, 50 and 100 µg/mL |
N/A |
Positive |
The test substance dissolved in distilled water |
Zengin N., Yüzbasıog˘lu D.,ünal F., Yılmaz S., Aksoy H., Food and Chemical Toxicology 49 (2011) 763-769 |
Sister chromosome exchange assays in mammalian cells (all studies are non-GLP) |
||||||
SCE |
human peripheral blood cells |
0.02, 0.2, 2, 4 and 8 mM |
N/A |
Positive |
The test substance |
Mpountoukas P., Vantarakis A., Sivridis E. and Lialiaris T., Food and Chemical Toxicology 46 (2008) 2390–2393 |
SCE, Sim. to OECD 479 |
Human peripheral lymphocytes |
6.25, 12.5, 25, 50 and 100 µg/mL |
N/A |
positive |
The test substance dissolved in distilled water |
Zengin N., Yüzbasıog˘lu D.,ünal F., Yılmaz S., Aksoy H., Food and Chemical Toxicology 49 (2011) 763-769 |
SCE |
Chinese hamster cell line (Don) |
0.001, 0.002, 0.005 and 0.01 M/plate |
N/A |
ambiguous |
The test substance dissolved in HBSS |
Abe, S. & Sasaki, M., J. Nat. Cancer Inst. 58, 1635-1641 |
DNA damage and/or repair |
Isolated human lymphocytes |
6.25, 12.5, 25, 50 and 100 µg/mL |
N/A |
Positive |
The test substance dissolved in distilled water |
Zengin N., Yüzbasıog˘lu D.,ünal F., Yılmaz S., Aksoy H., Food and Chemical Toxicology 49 (2011) 763-769 |
Summary of in vivo mutagenetic studies
Method/ Guideline |
Species, Strain, Sex, No/group |
Route and Frequency of application |
Sampling times
|
Dose levels |
Results give dose, sampling time and result +/-/+ |
Remarks
|
Reference |
Chromosome aberration assay, Sim. to OECD 475 |
Rat, Sprague-Dawley, male, 5/group |
Gavage a) single dose b) 5 d |
No information given |
50, 500 and 5000 mg/kg |
negative |
The test substance dissolved in 0.85% saline |
Fabrizio D.P.A., National Technical Information Service, PB 245453 |
Dominant lethal assay, Sim. to OECD 478 |
Rat, Sprague-Dawley, male/female, Ten males and twenty females/group |
Gavage a) single dose b) 1 dose per day for 5 d |
No information given |
50, 500 and 5000 mg/kg |
negative |
The test substance dissolved in saline |
Fabrizio D.P.A., National Technical Information Service, PB 245453 |
Host mediated assay |
Mouse, ICR, male, 10/group |
Gavage a) single dose b) 1 dose per day for 5 d |
No information given |
50, 500 and 5000 mg/kg |
negative |
The test substance dissolved in saline |
Fabrizio D.P.A., National Technical Information Service, PB 245453 |
Justification for selection of genetic toxicity endpoint
This is an in-vivo study which is conducted according to a reliable method compared to OECD 475 using rats.
Justification for classification or non-classification
Tests in vivo on germ cells (as in the dominant lethal assay) are negative. Therefore there is no need for classification. In principle in vivo tests will overrule the results of in vitro tests, as even for an in vitro mutagen it might not be possible to reach the target site in the organism and exhibit its effect on site.
Under classification the following will be included: Based on the data available sodium benzoate does not need to be classified for genotoxicity (DSD and 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.

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