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EC number: 935-721-8 | CAS number: -
- 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
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- 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:
- 2012, July 17 - 2012, Sep 19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homogenate metabolising system (10 % liver S9 in standard co-factors
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/plate
Mutation Test (Experiment 1): 5, 15, 50, 150, 500, 1500, 5000 µg/plate in triplicate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulphoxide
- Justification for choice of solvent/vehicle: The test item was immiscible in sterile distilled water at 50 mg/ml but was fully miscible in
dimethyl sulphoxide at the same concentration in solubility checks performed in-house. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- see details below
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Preliminary toxicity test: The test was performed by mixing 0.1 ml of bacterial culture (TA100 or WP2uvrA), 2 ml of molten, trace histidine or
tryptophan supplemented, top agar, 0.1 ml of test item formulation and 0.5 ml of S9-mix or phosphate buffer and overlaying onto sterile plates of Vogel-Bonner Minimal agar (30 ml/plate).
Ten concentrations of the test item formulation and a vehicle control (dimethyl sulphoxide) were tested.
After approximately 48 hrs incubation at 37°C the plates were assessed for numbers of revertant colonies using a colony counter and examined
for effects on the growth of the bacterial background lawn.
- Mutation Test (Experiment 1): Aliquots (0.1 ml) of one of the bacterial cultures were dispensed into sets of test tubes followed by 2 ml of molten,
trace histidine or tryptophan supplemented, top agar, 0.1 ml of the vehicle, test item formulation or positive control and either 0.5 ml of S9-mix or phosphate buffer.
The contents of each test tube were mixed and equally distributed onto the surface of Vogel-Bonner Minimal agar plates (one tube per plate).
This procedure was repeated, in triplicate, for each bacterial strain and for each concentration of test item both with and without S9-mix.
All of the plates were incubated at 37°C for approximately 48 hours and the frequency of revertant colonies assessed using a colony counter.
NUMBER OF REPLICATIONS: 3 per dose level, with and without metabolic activation (+S9 and -S9)
DETERMINATION OF CYTOTOXICITY
- Method: colony growth (background lawn) - Evaluation criteria:
- Criteria for determining a positive result: Any, one, or all of the criteria can be used to determine the overall result of the study:
- A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby (1979)).
- A reproducible increase at one or more concentrations.
- Biological relevance against in-house historical control ranges.
- Statistical analysis of data as determined by UKEMS [Mahon et al (1989)].
- Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
- A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
The reverse mutation assay may be considered valid if the following criteria are met:
- All bacterial strains must have demonstrated the required characteristics as determined by their respective strain checks according to Ames et al (1975),
Maron and Ames (1983) and Mortelmans and Zeiger (2000).
- All tester strain cultures should exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
(Acceptable ranges are presented in the report in the General Study Plan, Section 4 (negative controls)).
- All tester strain cultures should be in the range of 0.9 to 9 x 109 bacteria per ml.
- Diagnostic mutagens (positive control chemicals) must be included to demonstrate both the intrinsic sensitivity of the tester strains to mutagen exposure
and the integrity of the S9-mix. All of the positive control chemicals used in the study should induce marked increases in the frequency of revertant
colonies, both with or without metabolic activation.
- There should be a minimum of four non-toxic test item dose levels.
- There should be no evidence of excessive contamination. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: A test item precipitate (oily in appearance) was noted at 5000 µg/plate. Also a creamy film was observed at and above 1500 µg/plate.
Neither of these observations prevented the scoring of revertant colonies.
COMPARISON WITH HISTORICAL CONTROL DATA: Historical laboratory control data from 2010 and 2011 are documented in appendix 2 of the report
(History Profile of Vehicle and Positive Control Values)
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation
The test item, Novares LR 600, was considered to be mutagenic under the conditions of this test.
Reference
Tables below are from the original report:
Preliminary Toxicity Test:
The numbers of revertant colonies for the toxicity assay
S9-mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
99 |
90 |
90 |
70 |
96 |
144 |
240 |
434 |
548 |
632F |
804FP |
+ |
TA100 |
91 |
76 |
86 |
90 |
88 |
122 |
155 |
229 |
323 |
644F |
695FP |
- |
WP2uvrA |
38 |
27 |
33 |
37 |
30 |
37 |
47 |
62 |
93 |
95F |
124FP |
+ |
WP2uvrA |
34 |
45 |
34 |
37 |
45 |
34 |
60 |
36 |
45 |
56F |
75FP |
P: Test Item Precipitate; F: Test Item Film
Mutation Test Results: Experiment 1 – Without Metabolic Activation
Test Period |
From: 29 June 2012 |
To: 02 July 2012 |
|||||||||
With or Without S9-Mix |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||
- |
0 |
103 103 108 |
(105) 2.9# |
21 32 23 |
(25) 5.9 |
47 36 43 |
(42) 5.6 |
15 21 19 |
(18) 3.1 |
13 21 13 |
(16) 4.6 |
- |
5 |
108 106 160 |
(125) 30.6 |
40 27 31 |
(33) 6.7 |
45 39 43 |
(42) 3.1 |
21 20 23 |
(21) 1.5 |
8 23 20 |
(17) 7.9 |
- |
15 |
131 143 215 |
(163) 45.4 |
23 32 31 |
(29) 4.9 |
44 40 29 |
(38) 7.8 |
25 19 15 |
(20) 5.0 |
19 19 20 |
(19) 0.6 |
- |
50 |
215 251 254 |
** (240) 21.7 |
36 28 33 |
(32) 4.0 |
45 49 47 |
(47) 2.0 |
21 25 19 |
(22) 3.1 |
19 17 9 |
(15) 5.3 |
- |
150 |
319 394 362 |
$$$ (358) 37.6 |
37 47 69 |
* (51) 16.4 |
48 35 56 |
(46) 10.6 |
16 21 15 |
(17) 3.2 |
16 17 21 |
(18) 2.6 |
- |
500 |
510 548 560 |
$$$ (539) 26.1 |
102 84 91 |
$$$ (92) 9.1 |
100 107 103 |
$$$ (103) 3.5 |
20 35 23 |
(26) 7.9 |
12 16 15 |
(14) 2.1 |
- |
1500 |
464F 428F 478F |
$$$ (457) 25.8 |
92F 83F 122F |
$$$ (99) 20.4 |
107F 100F 90F |
$$$ (99) 8.5 |
19F 20F 13F |
(17) 3.8 |
11F 15F 15F |
(14) 2.3 |
- |
5000 |
954PF 560PF 668PF |
$$$ (727) 203.6 |
120PF 104PF 182PF |
$$$ (135) 41.2 |
71PF 80PF 68PF |
$$$ (73) 6.2 |
17PF 20PF 19PF |
(19) 1.5 |
13PF 16PF 13PF |
äüö(14) 1.7 |
Positive controls - S9-Mix |
Name Concentration (μg/plate) No. colonies per plate |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
3 |
5 |
2 |
0.2 |
80 |
|||||||
521 477 444 |
(481) 38.6 |
271 303 273 |
(282) 17.9 |
748 875 830 |
(818) 64.4 |
135 115 146 |
(132) 15.7 |
452 707 462 |
(540) 144.4 |
ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; 4NQO: 4-Nitroquinoline-1-oxide; 9AA 9 -aminoacridine
P: Test Item Precipitate; F: Test Item Film
*: p <= 0.05; **: p <= 0.01; $$$: p <= 0.005; #: Standard deviation
Mutation Test Results: Experiment 1 – With Metabolic Activation
Test Period |
From: 29 June 2012 |
To: 02 July 2012 |
||||||||||
With or Without |
Test substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate) |
||||||||||
Base-pair substitution type |
Frameshift type |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
+ |
0 |
88 90 92 |
(90) 2.0# |
13 7 13 |
(11) 3.5 |
51 35 52 |
(46) 9.5 |
16 23 16 |
(18) 4.0 |
12 27 17 |
(19) 7.6 |
|
+ |
5 |
100 106 108 |
(105) 4.2 |
29 25 15 |
(23) 7.2 |
53 53 53 |
(53) 0.0 |
16 21 20 |
(19) 2.6 |
28 17 16 |
(20) 6.7 |
|
+ |
15 |
116 115 127 |
(119) 6.7 |
33 40 24 |
* (32) 8.0 |
44 57 45 |
(49) 7.2 |
21 21 19 |
(20) 1.2 |
20 17 15 |
(17) 2.5 |
|
+ |
50 |
168 171 152 |
** (164) 10.2 |
53 91 60 |
$$$ (68) 20.2 |
56 60 43 |
(53) 8.9 |
19 13 13 |
(15) 3.5 |
17 15 16 |
(16) 1.0 |
|
+ |
150 |
225 254 257 |
$$$ (245) 17.7 |
112 126 159 |
$$$ (132) 24.1 |
57 71 61 |
* (63) 7.2 |
20 19 21 |
(20) 1.0 |
9 19 25 |
(18) 8.1 |
|
+ |
500 |
412 362 369 |
$$$ (381) 27.1 |
241 270 278 |
$$$ (263) 19.5 |
49 49 59 |
(52) 5.8 |
13 23 32 |
(23) 9.5 |
11 13 12 |
(12) 1.0 |
|
+ |
1500 |
640F 540F 597F |
$$$ (592) 50.2 |
448F 366F 357F |
$$$ (390) 50.1 |
72F 61F 65F |
* (66) 5.6 |
15F 24F 28F |
(22) 6.7 |
9F 11F 19F |
(13) 5.3 |
|
+ |
5000 |
1144PF 1040PF 839PF |
$$$ (1008) 155.0 |
417PF 512PF 410PF |
$$$ (446) 57.0 |
104PF 84PF 74PF |
$$$ (87) 15.3 |
20PF 11PF 8PF |
(13) 6.2 |
3PF 4PF 5PF |
(4) 1.0 |
|
Positive controls + S9-Mix |
Name Concentration (μg/plate) No. colonies per plate |
2AA |
2AA |
2AA |
BP |
2AA |
||||||
1 |
2 |
10 |
5 |
2 |
||||||||
1429 1387 1330 |
(1382) 49.7 |
305 295 289 |
(296) 8.1 |
424 394 404 |
(407) 15.3 |
156 199 188 |
(181) 22.3 |
178 186 215 |
(193) 19.5 |
2AA: 2-Aminoanthracene; BP: Benzo(a)pyrene
P: Test Item Precipitate; F: Test Item Film
*: p <= 0.05; **: p <= 0.01; $$$: p <= 0.005; #: Standard deviation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Justification for classification or non-classification
Based on current findings, no classification for mutagenic potential is required.
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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