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EC number: 228-001-3 | CAS number: 6066-82-6
- 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
In vitro gene mutation study in bacteria: Key study: Similar to OECD 471. The test item did not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 with and without metabolic activation up to 5000 µg/plate.
In vitro gene mutation study in yeast: Supporting study: Under the test conditions, the test item showed neither mitotic conversion nor death in Saccharomyces cerevisiae D4-RD up to 5 mg/ml.
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:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only four strains tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Chemical Dynamics (South Plainfield, NJ). - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Bacterial strains were received from B.N. Ames.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 100, 500, 1000 and 5000 µg/plate.
No toxicity was observed at the highest dose (5000 µg/plate). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: the test item is completely soluble in the vehicle - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- other: N-methyl-N'-nitro-N-nitrosoguanidine; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 1E08 cells/ml
The plate incorporation assay was conducted accoding to Ames et al. (1975). To 2 ml of molten top agar at 45ºC were added 0.1 ml bacterial culture containing approximately 1E08 cells/ml, 0.1 ml test solution or solvent and 0.5 ml S) mix or buffer. After mixing, the soft agar was poured onto selective minimal agar plates.
DURATION
- Exposure duration: 2 days at 37 ºC
SELECTION AGENT (mutation assays): lack of histidine in the media
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: Toxicity was stimated by examining background bacterial lawns using a stereoscope.
- OTHER:
Preparation of the metabolic activation system: S9 was prepared from aroclor 1254-induced male Sprague-Dawley rat livers. - Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Conclusions:
- The test item did not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 with and without metabolic activation up to 5000 µg/plate.
- Executive summary:
A study to determine the ability of the test item to induce mutation was assessed by the bacterial reverse mutation test, performed according to the method described by Ames, similar to OECD 471. Four histidine dependent strains of Salmonella typhimurium (TA 1535, TA1537, TA 98 and TA 100) were exposed to 0, 100, 500, 1000 and 5000 µg/plate of the test item in presence and absence of S9 rat liver metabolic activation, by the plate incorporation method. Under the experimental conditions used, the test item did no induce an increase in the number of revertants in any strain at any dose level, either with or without metabolic activation. Therefore, the test item was not mutagenic.
- Endpoint:
- genetic toxicity in vitro, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1971
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- - Principle of test: To evaluate the mitotic gene conversion in Saccharomyces cerevisiae of a substance.
- Short description of test conditions: Determination of mutation frequencies of the diploid strain D4-RD of Saccharomyces cerervisiae after the cehmical exposure by the liquid-holding system. The diploid Saccaromyces cerevisiae strain D4-RD cells only grow after addion of anenine and tryptophan to the medium, in addition to non-fermentable carbon sources.
- Parameters analysed / observed: Determination of the spontaneous convertion frequency. - GLP compliance:
- no
- Type of assay:
- mitotic recombination assay with Saccharomyces cerevisiae
- Target gene:
- Adenine 2-locus and tryptophan 5-locus.
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Remarks:
- D4-RD
- Metabolic activation:
- not specified
- Test concentrations with justification for top dose:
- Maximum dose: 5 mg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: No data.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION.The assay was carried out according to the method described by Maquart and Zimmermann (1970) [see attached background material].
- Cell density at seeding (if applicable): Each tube was inoculated with about 300 cells.
Cells were grown in 5 ml liquid YEP (1% Difco yeast extract, 2% Difco bactopeptone, 2% glucose). The test item was dissolved and diluted to 1:100 in the cell suspension.
DURATION
- Exposure duration: 4 days at 25ºC.
SELECTION AGENT (mutation assays): glucose free solution. - Rationale for test conditions:
- The saccharomyces D4-RD strain is much more sensitive to genetically active substances at 25ºC.
- Key result
- Species / strain:
- Saccharomyces cerevisiae
- Remarks:
- D4-RD
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Under the test conditions, the test item showed neither mitotic conversion nor death in Saccharomyces cerevisiae D4-RD up to 5 mg/ml.
- Executive summary:
A mitotic gene conversion test in Saccharomyces cerevisiae was performed with the test item. The test was carried out with the diploid strain D4 -RD of Saccharomyces cerevisiae in adenine 2 -locus and tryptophan 5 -locus, which additionally has a respiratory defect. This strain is much more sensitive to genetically active substances at 25ºC. A suspension of about 300 cells was exposed to the test item in a glucose-free 5 ml of liquid-holding solution for 4 days at 25ºC. Under the test conditions, the test item showed neither mitotic conversion nor death in Saccharomyces cerevisiae D4-RD up to 5 mg/ml.
Referenceopen allclose all
Table 1.Number of revertant colonies after exposure to N-hydroxisuccinimide or positive control with metabolic activation.
Strain |
Positive control |
Amount tested (µg/plate) |
Mean number of colonies per plate |
|
N-hydroxysuccinimide |
Positive control |
|||
TA 1535 |
- |
5000 |
11 |
- |
- |
1000 |
11 |
- |
|
- |
500 |
14 |
- |
|
- |
100 |
10 |
- |
|
- |
0 |
13 |
- |
|
2-AA |
10 |
- |
183 |
|
TA 1537 |
- |
5000 |
9 |
- |
- |
1000 |
5 |
- |
|
- |
500 |
7 |
- |
|
- |
100 |
9 |
- |
|
- |
0 |
11 |
- |
|
2-AA |
50 |
- |
175 |
|
TA 98 |
- |
5000 |
30 |
- |
- |
1000 |
28 |
- |
|
- |
500 |
26 |
- |
|
- |
100 |
28 |
- |
|
- |
0 |
35 |
- |
|
2-AA |
20 |
- |
1137 |
|
TA 100 |
- |
5000 |
168 |
- |
- |
1000 |
184 |
- |
|
- |
500 |
176 |
- |
|
- |
100 |
176 |
- |
|
- |
0 |
211 |
- |
|
2-AA |
10 |
- |
1535 |
2-AA: 2-aminoanthracene
Table 2.Number of revertant colonies after exposure to N-hydroxisuccinimide or positive control without metabolic activation.
Strain |
Positive control |
Amount tested (µg/plate) |
Mean number of colonies per plate |
|
N-hydroxysuccinimide |
Positive control |
|||
TA 1535 |
- |
5000 |
15 |
- |
- |
1000 |
10 |
- |
|
- |
500 |
15 |
- |
|
- |
100 |
12 |
- |
|
- |
0 |
13 |
- |
|
MNNG |
5 |
- |
1190 |
|
TA 1537 |
- |
5000 |
4 |
- |
- |
1000 |
7 |
- |
|
- |
500 |
7 |
- |
|
- |
100 |
5 |
- |
|
- |
0 |
7 |
- |
|
9-AA |
5 |
- |
322 |
|
TA 98 |
- |
5000 |
19 |
- |
- |
1000 |
22 |
- |
|
- |
500 |
15 |
- |
|
- |
100 |
23 |
- |
|
- |
0 |
15 |
- |
|
2-NF |
5 |
- |
959 |
|
TA 100 |
- |
5000 |
160 |
- |
- |
1000 |
163 |
- |
|
- |
500 |
157 |
- |
|
- |
100 |
174 |
- |
|
- |
0 |
172 |
- |
|
MNNG |
5 |
- |
1055 |
MNNG: N-methyl-N’-nitro-N-nitrosoguanidine
9-AA: 9-aminoacrinide
2-NF: 2-nitrofluorene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro gene mutation study in bacteria:
Key study: A study to determine the ability of the test item to induce mutation was assessed by the bacterial reverse mutation test, performed according to the method described by Ames, similar to OECD 471. Four histidine dependent strains of Salmonella typhimurium (TA 1535, TA1537, TA 98 and TA 100) were exposed to 0, 100, 500, 1000 and 5000 µg/plate of the test item in presence and absence of S9 rat liver metabolic activation, by the plate incorporation method. Under the experimental conditions used, the test item did no induce an increase in the number of revertants in any strain at any dose level, either with or without metabolic activation. Therefore, the test item was not mutagenic.
In vitro gene mutation study in yeast:
Supporting study: A mitotic gene conversion test in Saccharomyces cerevisiae was performed with the test item. The test was carried out with the diploid strain D4 -RD of Saccharomyces cerevisiae in adenine 2 -locus and tryptophan 5 -locus, which additionally has a respiratory defect. This strain is much more sensitive to genetically active substances at 25ºC. A suspension of about 300 cells was exposed to the test item in a glucose-free 5 ml of liquid-holding solution for 4 days at 25ºC. Under the test conditions, the test item showed neither mitotic conversion nor death in Saccharomyces cerevisiae D4-RD up to 5 mg/ml.
Justification for classification or non-classification
Based on the available information, the test item is not classified as mutagen according to CLP Regulation (EC) no. 1272/2008.
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