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EC number: 203-500-9 | CAS number: 107-54-0
- 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
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
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Salmonella typhimurium
Strains Genotype Type of mutations indicated
TA1537 his C 3076; rfa-; uvrB-: frame shift mutation
TA98 his D3052; rfa-; uvrB-; R-factor frame shift mutation
TA1535 his G 46; rfa-; uvrB-: base pair substitution
TA1535 his G 46; rfa-; uvrB-; R-factor base pair substitution
Escherichia coli
Strain Genotype Type of mutations indicated
WP2uvrA trp-; uvrA-: base pair substitution - Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 1.5, 5, 15, 50, 150, 1500, 5000 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Conclusions:
- Interpretation of results (migrated information):
negative
This substance was considered to be non-mutagenic under the conditions of this test according to OECD Guideline 471. - Executive summary:
This substance was considered to be non-mutagenic under the conditions of this test according to OECD Guideline 471.
Reference
Test Results: Main Test - Without Metabolic Activation | |||||||||||||
Test Period | From: 27. October 2014 31. October 2014* | To: 30. October 2014 // 03. November 2014* | |||||||||||
S9-Mix | Dose Level per Plate | Number of Revertants (Mean) +/- SD | |||||||||||
Base-Pair Substitution Strains | Frameshift Strains | ||||||||||||
TA100 | TA1535* | WP2uvrA | TA98* | TA1537* | |||||||||
Solvent Control (DMSO) | 82 | (88) 4.9# |
15 | (13)4.9 | 7 | (12)4.2 | 25 | (22)6.4 | 8 | (10)2.1 | |||
91 | 7 | 15 | 15 | 12 | |||||||||
90 | 16 | 13 | 27 | 11 | |||||||||
5µg | 103 | (96)6.1 | 11 | (11)0.6 | 20 | **(20)0.6 | 8 | (17)10.1 | 8 | (15)3.2 | |||
91 | 11 | 20 | 15 | 12 | |||||||||
95 | 12 | 19 | 28 | 11 | |||||||||
15µg | 79 | (89)0.5 | 15 | (11)3.8 | 16 | (14)2.1 | 17 | (15)5.7 | 8 | (15)2.3 | |||
100 | 8 | 12 | 20 | 12 | |||||||||
88 | 9 | 15 | 9 | 11 | |||||||||
50µg | 118 | (95)20.6 | 9 | (11)3.5 | 12 | (13)2.1 | 13 | (18)6.4 | 8 | (14)8.7 | |||
87 | 9 | 11 | 25 | 12 | |||||||||
79 | 15 | 15 | 15 | 11 | |||||||||
150µg | 80 | (102)19.5 | 24 | (19)6.8 | 17 | (17)2.5 | 31 | (22)8.1 | 8 | (8)4.0 | |||
116 | 11 | 15 | 17 | 12 | |||||||||
111 | 21 | 20 | 17 | 11 | |||||||||
500µg | 116 | (101)28.3 | 17 | (14)3.1 | 17 | (16)5.0 | 20 | (16)3.5 | 8 | (8)4.2 | |||
118 | 15 | 11 | 13 | 12 | |||||||||
68 | 11 | 21 | 16 | 11 | |||||||||
1500µg | 64 S | (51)6.4 | 19 S | (13)5.1 | 12 S | (16)4.0 | 19 | (15)4.0 | 8 | (5)1.7 | |||
69 S | 12 S | 17 S | 11 | 12 | |||||||||
21 S | 9 S | 20 S | 16 | 11 | |||||||||
5000µg | 0 V | (0)0.0 | 0 T | (0)0.0 | 0 T | (0)0.0 | 0 T | (0)0.0 | 0 T | (0)0.0 | |||
0 V | 0 T | 0 T | 0 T | 0 T | |||||||||
0 V | 0 T | 0 T | 0 T | 0 T | |||||||||
PositiveControlsS9-Mix(-) | Name Dose LevelNo. of Revertants | ENNG | ENNG | ENNG | 4NQO | 9AA | |||||||
3 µg | 5 µg | 2 µg | 0.2 µg | 80 µg | |||||||||
282 | (283)10.0 | 731 | (649)72.4 | 768 | (716)45.4 | 186 | (203)22.9 | 275 | (420)127.0 | ||||
293 | 624 | 684 | 229 | 476 | |||||||||
273 | 563 | 696 | 194 | 510 | |||||||||
Test Results: Main Test - With Metabolic Activation | |||||||||||||
Test Period | From: 27. October 2014 31. October 2014* | To: 30. October 2014 03. November 2014* | |||||||||||
S9-Mix | Dose Level per Plate | Number of Revertants (Mean) +/- SD | |||||||||||
Base-pair substitution Strains | Frameshift Strains | ||||||||||||
TA100 | TA1535* | WP2uvrA | TA98* | TA1537* | |||||||||
Solvent Control (DMSO) | 82 | (88)5.2# | 19 | (18)2.1 | 24 | (19)4.0 | 29 | (27)3.5 | 23 | (18)4.0 | |||
91 | 16 | 17 | 23 | 16 | |||||||||
91 | 20 | 17 | 29 | 16 | |||||||||
5µg | 111 | (103)21.7 | 19 | (18)1.2 | 16 | (19)12.2 | 24 | (24)0.6 | 19 | (16)6.7 | |||
119 | 19 | 32 | 24 | 20 | |||||||||
78 | 17 | 8 | 23 | 8 | |||||||||
15µg | 79 | (91)11.5 | 15 | (14)1.2 | 13 | (12)3.1 | 25 | (26)1.7 | 13 | (14)2.3 | |||
102 | 13 | 15 | 25 | 17 | |||||||||
91 | 13 | 9 | 28 | 13 | |||||||||
50µg | 102 | (105)6.4 | 9 | (12)3.1 | 11 | (10)1.2 | 25 | (26)1.2 | 11 | (15)4.7 | |||
112 | 15 | 11 | 25 | 20 | |||||||||
100 | 13 | 9 | 27 | 13 | |||||||||
150µg | 107 | (105)8.2 | 11 | (14)3.1 | 27 | (23)3.5 | 15 | (20)7.0 | 13 | (13)1.5 | |||
112 | 17 | 23 | 28 | 15 | |||||||||
96 | 15 | 20 | 17 | 12 | |||||||||
500µg | 86 | (104) 16.1 | 13 | (16)3.6 | 11 | (15)4.0 | 21 | (22)1.2 | 8 | (8)1.0 | |||
116 | 20 | 16 | 21 | 9 | |||||||||
111 | 15 | 19 | 23 | 7 | |||||||||
1500µg | 74 S | (86)15.9 | 0 V | (0)0.0 | 15 | (16)1.2 | 16 | (20)7.2 | 8 | (10)4.0 | |||
80 S | 0 V | 17 | 28 | 8 | |||||||||
104S | 0 V | 15 | 15 | 15 | |||||||||
5000µg | 0 V | (0)0.0 | 0 V | (0)0.0 | 15 S | (9)5.3 | 0 T | (0)0.0 | 6 S | (4)1.5 | |||
0 V | 0 V | 5 S | 0 T | 4 S | |||||||||
0 V | 0 V | 7 S | 0 T | 3 S | |||||||||
Positive controls S9-Mix (-) |
Name Dose Level No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
|||||||
1 µg |
2 µg |
10 µg |
5 µg |
2 µg |
|||||||||
417 |
(330) 80.6 |
290 |
(268) 20.4 |
164 |
(162) 29.6 |
128 |
(131) 9.5 |
517 |
(515) 2.1 |
||||
315 |
263 |
131 |
142 |
513 |
|||||||||
258 |
250 |
190 |
124 |
516 |
|||||||||
* Experimental procedure repeated at a later date due to contamination in the original test. |
|||||||||||||
** p≤0.05 |
|||||||||||||
ENNG N-ethyl-N´-nitro-N-nitrosoguanidine |
|||||||||||||
4NQO 4-Nitroquinoline-1-oxide |
|||||||||||||
9AA 9-Aminoacridine |
|||||||||||||
BP Benzo(a)pyrene |
|||||||||||||
2AA 2-Aminoanthracene |
|||||||||||||
S Sparse bacterial background lawn |
|||||||||||||
T Toxic, no bacterial background lawn |
|||||||||||||
V Very weak bacterial background lawn |
|||||||||||||
# Standard deviation |
|||||||||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for selection of genetic toxicity endpoint
Only one test available. Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.
Justification for classification or non-classification
According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.5 this substance is not causing concern to be mutagenetic toxic.
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.
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