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EC number: 455-600-9 | CAS number: 790240-84-5
- 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:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- 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:
- other:
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: given in table below
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fractions of rats, induced with phenobarbital/beta-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-Experiment and Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- Solvent: Deionised water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (TA1535, TA100), 4-nitro-o-phenylene-diamine (TA1537, TA98), methyl methane sulfonate (WP2uvrA); 2-aminoanthracene (all strains with metabolic activation)
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 µg/plate
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA98, TA100, and WP2uvrA) or thrice (strains TA1535 and TA1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Species / strain:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- In the pre-experiment the concentration range of the test item was 3-5000 µg/plate. The pre-experiment is reported as experiment I since no toxic effects were observed and 5000 µg/plate were chosen as maximal concentration.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments.
No toxic effects, evident as a reduction in the number of revertants, were observed with and without metabolic activation in experiment I. In experiment II, minor toxic effects were observed in the presence of metabolic activation in strain TA1537 at 5000 µg/plate and in strain TA100 from 1000 up to 5000 µg/plate.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Red LF 6382/18L-R at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
The number of colonies exceeded the laboratory's historical control range slightly in the negative control of strain WP2 uvrA with and without metabolic activation in experiment I. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies and has no impact on the outcome of the study.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
not relevant for classification and labelling; - Executive summary:
This study was performed according to OECD Guideline 471 to investigate the potential of the substance to induce gene mutations in the plate incorporation test and the pre-incubation test using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The substance was incubated in concentrations from 3-5000 µg/plate (experiment I) and from 33-5000 µg/plate (experiment II) either with and without metabolic activation (rat S9 mix). Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies. The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in both independent experiments. No toxic effects, evident as a reduction in the number of revertants, were observed with and without metabolic activation in experiment I. In experiment II, minor toxic effects were observed in the presence of metabolic activation in strain TA 1537 at 5000 µg/plate and in strain TA 100 from 1000 up to 5000 µg/plate.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the substance is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
Reference
Table 2: Summary of Results Pre-Experiment and Experiment I
Metabolic activation |
Test group |
Dose level [µg/plate] |
Revertant colony counts (Mean±SD) |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|||
Without |
Water |
|
23±1 |
10±3 |
32±3 |
134±7 |
60±7 |
Untreated |
|
29±2 |
14±3 |
25±5 |
128±6 |
64±13 |
|
Red LF6382/18L-R |
3 |
24±3 |
10±3 |
25±3 |
120±2 |
59±3 |
|
10 |
21±1 |
14±1 |
24±11 |
138±13 |
64±9 |
||
33 |
19±7 |
8±6 |
23±1 |
128±5 |
79±18 |
||
100 |
22±4 |
13±6 |
24±6 |
129±9 |
67±7 |
||
333 |
27±7 |
10±2 |
28±8 |
135±10 |
60±5 |
||
1000 |
23±3 |
9±3 |
24±8 |
141±3 |
58±9 |
||
2500 |
16±3 |
7±1 |
26±7 |
134±7 |
56±4 |
||
5000 |
17±3 |
5±1 |
17±2 |
123±12 |
46±8 |
||
Sodium azide |
10 |
1715±36 |
|
|
2381±161 |
|
|
4-NOPD |
10 |
|
|
369±23 |
|
|
|
4-NOPD |
50 |
|
83±9 |
|
|
|
|
MMS |
4 µL |
|
|
|
|
1556±63 |
|
With |
Water |
|
34±12 |
16±5 |
38±15 |
151±7 |
62±6 |
Untreated |
|
30±10 |
13±4 |
36±4 |
166±8 |
69±13 |
|
Red LF6382/18L-R |
3 |
30±1 |
11±3 |
47±5 |
155±7 |
68±10 |
|
10 |
30±6 |
13±5 |
40±4 |
168±2 |
61±11 |
||
33 |
32±3 |
12±2 |
31±3 |
159±2 |
83±26 |
||
100 |
28±7 |
12±2 |
36±2 |
154±12 |
70±5 |
||
333 |
29±2 |
14±6 |
40±7 |
149±10 |
61±8 |
||
1000 |
28±2 |
12±4 |
33±10 |
130±18 |
57±7 |
||
2500 |
24±2 |
9±2 |
31±4 |
128±9 |
61±6 |
||
5000 |
21±3 |
7±2 |
20±5 |
123±14 |
50±10 |
||
2-AA |
2.5 |
378±5 |
317±13 |
2196±27 |
1323±325 |
|
|
2-AA |
10 |
|
|
|
|
222±14 |
4-NOPD 4-nitro-o-phenylene-diamine
MMS methyl methane sulfonate
2-AA 2-aminoanthracene
Table 3: Summary of Results Experiment II
Metabolic activation |
Test group |
Dose level [µg/plate] |
Revertant colony counts (Mean±SD) |
||||
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|||
Without |
Water |
|
21±1 |
14±6 |
26±6 |
161±25 |
47±10 |
Untreated |
|
18±3 |
17±4 |
25±2 |
154±14 |
44±5 |
|
Red LF6382/18L-R |
33 |
19±4 |
19±4 |
29±7 |
154±21 |
54±10 |
|
100 |
19±8 |
17±2 |
30±6 |
161±20 |
54±9 |
||
333 |
24±4 |
21±4 |
29±11 |
157±25 |
51±10 |
||
1000 |
26±5 |
17±3 |
27±10 |
145±15 |
44±3 |
||
2500 |
23±4 |
11±1 |
18±3 |
134±6 |
37±4 |
||
5000 |
20±4 |
10±3 |
22±2 |
112±10 |
35±3 |
||
Sodium azide |
10 |
1531±67 |
|
|
2192±80 |
|
|
4-NOPD |
10 |
|
|
377±26 |
|
|
|
4-NOPD |
50 |
|
84±6 |
|
|
|
|
MMS |
4 µL |
|
|
|
|
315±32 |
|
With |
Water |
|
23±2 |
24±3 |
41±1 |
195±22 |
50±1 |
Untreated |
|
27±4 |
29±2 |
48±8 |
162±1 |
54±8 |
|
Red LF6382/18L-R |
33 |
22±8 |
26±5 |
44±7 |
186±24 |
52±8 |
|
100 |
29±5 |
24±3 |
50±9 |
184±11 |
53±13 |
||
333 |
31±6 |
27±4 |
50±1 |
150±12 |
45±3 |
||
1000 |
29±6 |
26±3 |
45±1 |
79±7 |
56±6 |
||
2500 |
23±3 |
23±4 |
31±6 |
82±9 |
37±5 |
||
5000 |
24±3 |
10±2 |
28±2 |
76±7 |
37±5 |
||
2-AA |
2.5 |
397±24 |
269±5 |
2065±206 |
2559±334 |
|
|
2-AA |
10 |
|
|
|
|
319±26 |
4-NOPD 4-nitro-o-phenylene-diamine
MMS methyl methane sulfonate
2-AA 2-aminoanthracene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Three valid in vitro mutagenicity tests with the registration substance are available.
OECD 471 Ames test
In order to investigate the potential of the substance to induce gene mutations, a valid Ames test was performed, where the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA were tested. The substance was incubated in concentrations from 3-5000 µg/plate (experiment I) and from 33-5000 µg/plate (experiment II) either with and without metabolic activation (rat S9 mix). Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the substance registered did not induce gene mutations.
OECD 473 Chromosome Aberration test
Under the experimental conditions reported, the substance registered did not induce structural chromosome aberrations as determined by the chromosome aberration test in V79 cells (Chinese hamster cell line) in vitro.Therefore, the substance is considered to be non-clastogenic in this chromosome aberration test with and without S9 mix when tested up to precipitating concentrations (4 hrs treatment with and without S9 mix) or up to the highest scorable concentrations (18 hrs and 28 hrs continuous treatment without S9 mix).
OECD 476 HPRT
Under the experimental conditions reported the substance registered did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test substance registered is considered to be non-mutagenic.
Based on the negative results from three valid in vitro mutagenicity tests, it is considered that the test substance registered has no mutagenic potential.
Justification for classification or non-classification
The available three in vitro genotoxicity studies on the substance registered revealed all negative results. On this basis the substance registered is not to be classified as to its genotoxic properties.
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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