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Reactions mass of N-{2-[(4-bromo-6-substituted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-methoxyalkyl)amino]phenyl}acetamide) and N-{2-[(4-bromo-6-substiuted-2-alkyl-1,3-dioxo-2,3-dihydro-1H-isoindol-5-yl)diazenyl]-[alkyl(2-hydroxy-3-phenoxypropyl)amino]phenyl}acetamide
EC number: - | 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
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- 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:
- 19 February 2014 to 26 March 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- 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
Test material
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9 (experiment I) and non-induced hamster liver S9 (experiment II)
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / experiment II - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: suspended in DMSO
- Justification for choice of solvent/vehicle: best suitable solvent
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; preincubation;
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- 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 TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) 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.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in strains TA 1535 and TA 1537
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: not soluble
- Precipitation:
The test item precipitated in the overlay agar in the test tubes from 100 to 5000 µg/plate in experiment I and from 1000 to 5000 µg/plate in experiment II. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 333 to 5000 µg/plate in both experiments. The undissolved particles had no influence on the data recording.
- Other confounding effects: none
COMPARISON WITH HISTORICAL CONTROL DATA: performed no deviation
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred most of the strains. A minor reduction in the number of revertants (below the indication factor of 0.5) was observed in strains TA 1535 and TA 1537 in experiment I without S9 mix at 2500 µg/plate and in experiment II in strain TA 1537 in the absence of metabolic activation at 5000 µg/plate and in strain TA 1535 in the presence of metabolic activation at 5000 µg/plate. - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table1 Summary of Experiment I
Study Name: 1610101 |
Study Code: Harlan CCR 1610101 |
Experiment: 1610101 VV Plate |
Date Plated: 19/02/2014 |
Assay Conditions: |
Date Counted: 26/02/2014 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
18 ± 1 |
14 ± 0 |
21 ± 4 |
83 ± 10 |
47 ± 8 |
Untreated |
|
|
18 ± 4 |
10 ± 4 |
26 ± 5 |
97 ± 6 |
48 ± 11 |
|
FAT 41044/A |
3 µg |
|
17 ± 4 |
12 ± 2 |
27 ± 4 |
86 ± 8 |
48 ± 6 |
|
TE |
10 µg |
|
14 ± 0 |
13 ± 4 |
21 ± 4 |
89 ± 5 |
53 ± 5 |
|
|
33 µg |
|
14 ± 1 |
10 ± 1 |
19 ± 3 |
84 ± 9 |
45 ± 5 |
|
|
100 µg |
|
18 ± 4 |
10 ± 2 |
25 ± 5 |
97 ± 12 |
43 ± 10 |
|
|
333 µg |
|
16 ± 3P |
9 ± 1P |
21 ± 2P |
92 ± 11P |
43 ± 1P |
|
|
1000 µg |
|
10 ± 2P |
8 ± 2P |
15 ± 4P |
91 ± 10P |
44 ± 3P |
|
|
2500 µg |
|
8 ± 1P |
6 ± 3P |
20 ± 4P |
91 ± 10P |
38 ± 4P |
|
|
5000 µg |
|
10 ± 1P M |
6 ± 2P M |
17 ± 1P M |
81 ± 6P M |
37 ± 2P M |
|
NaN3 |
10 µg |
|
2630 ± 130 |
|
|
2117 ± 90 |
|
|
4-NOPD |
10 µg |
|
|
|
287 ± 30 |
|
|
|
4-NOPD |
50 µg |
|
|
59 ± 2 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
856 ± 40 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
13 ± 4 |
14 ± 2 |
29 ± 2 |
111 ± 8 |
55 ± 9 |
Untreated |
|
|
18 ± 6 |
14 ± 2 |
42 ± 8 |
126 ± 6 |
62 ± 4 |
|
FAT 41044/A |
3 µg |
|
12 ± 2 |
14 ± 4 |
41 ± 6 |
102 ± 7 |
51 ± 5 |
|
TE |
10 µg |
|
14 ± 4 |
12 ± 3 |
38 ± 5 |
104 ± 4 |
51 ± 9 |
|
|
33 µg |
|
13 ± 1 |
15 ± 2 |
30 ± 4 |
99 ± 6 |
59 ± 13 |
|
|
100 µg |
|
13 ± 3 |
16 ± 1 |
33 ± 9 |
108 ± 9 |
53 ± 6 |
|
|
333 µg |
|
11 ± 3P |
20 ± 3P |
39 ± 4P |
101 ± 12P |
56 ± 5P |
|
|
1000 µg |
|
13 ± 5P |
11 ± 2P |
44 ± 11P |
103 ± 21P |
48 ± 6P |
|
|
2500 µg |
|
8 ± 2P |
13 ± 1P |
38 ± 8P |
76 ± 5P |
46 ± 7P |
|
|
5000 µg |
|
7 ± 2P M |
12 ± 2P M |
42 ± 2P M |
91 ± 5P M |
45 ± 6P M |
|
2-AA |
2.5 µg |
|
577 ± 11 |
391 ± 15 |
3248 ± 386 |
3478 ± 18 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
251 ± 18 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P M |
Precipitate Manual count |
Table2 Summary of Experiment II
Study Name: 1610101 |
Study Code: Harlan CCR 1610101 |
Experiment: 1610101 HV2 Pre |
Date Plated: 20/03/2014 |
Assay Conditions: |
Date Counted: 26/03/2014 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
DMSO |
|
|
12 ± 3 |
11 ± 2 |
22 ± 4 |
87 ± 11 |
45 ± 5 |
Untreated |
|
|
12 ± 4 |
10 ± 4 |
27 ± 6 |
108 ± 15 |
52 ± 6 |
|
FAT 41044/A |
10 µg |
|
12 ± 2 |
9 ± 2 |
22 ± 7 |
82 ± 10 |
46 ± 7 |
|
TE |
33 µg |
|
14 ± 4 |
7 ± 2 |
21 ± 2 |
85 ± 19 |
48 ± 8 |
|
|
100 µg |
|
12 ± 3 |
7 ± 2 |
25 ± 3 |
88 ± 12 |
51 ± 3 |
|
|
333 µg |
|
18 ± 7P |
11 ± 2P |
23 ± 4P |
88 ± 3P |
51 ± 4P |
|
|
1000 µg |
|
19 ± 3P |
7 ± 2P |
26 ± 4P |
76 ± 11P |
53 ± 4P |
|
|
2500 µg |
|
15 ± 6P M |
5 ± 1P M |
19 ± 1P M |
80 ± 3P M |
48 ± 2P M |
|
|
5000 µg |
|
7 ± 2P M |
4 ± 2P M |
18 ± 7P M |
81 ± 6P M |
43 ± 3P M |
|
NaN3 |
10 µg |
|
2892 ± 223 |
|
|
1995 ± 70 |
|
|
4-NOPD |
10 µg |
|
|
|
286 ± 17 |
|
|
|
4-NOPD |
50 µg |
|
|
60 ± 11 |
|
|
|
|
MMS |
2 µL |
|
|
|
|
|
721 ± 22 |
|
|
|
|
|
|
|
|
|
|
With Activation |
DMSO |
|
|
25 ± 3 |
30 ± 0 |
44 ± 13 |
89 ± 11 |
61 ± 11 |
Untreated |
|
|
22 ± 7 |
25 ± 1 |
52 ± 7 |
86 ± 14 |
67 ± 6 |
|
FAT 41044/A |
10 µg |
|
21 ± 4 |
35 ± 2 |
49 ± 5 |
86 ± 10 |
60 ± 10 |
|
TE |
33 µg |
|
20 ± 5 |
36 ± 7 |
50 ± 1 |
82 ± 10 |
58 ± 7 |
|
|
100 µg |
|
23 ± 8 |
27 ± 3 |
46 ± 2 |
85 ± 20 |
53 ± 2 |
|
|
333 µg |
|
17 ± 3P |
33 ± 8P |
52 ± 3P |
76 ± 10P |
52 ± 4P |
|
|
1000 µg |
|
18 ± 5P |
30 ± 3P |
49 ± 6P |
71 ± 1P |
50 ± 2P |
|
|
2500 µg |
|
14 ± 8P |
27 ± 7P |
51 ± 3P |
55 ± 4P |
45 ± 7P |
|
|
5000 µg |
|
9 ± 2P M |
24 ± 6P M |
52 ± 10P M |
64 ± 14P M |
45 ± 9P M |
|
2-AA |
2.5 µg |
|
|
|
|
1388 ± 33 |
|
|
2-AA |
2.5 µg |
|
562 ± 16 |
201 ± 15 |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
|
792 ± 113 |
|
Congo red |
500 µg |
|
|
|
262 ± 23 |
|
|
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD Congo red MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine Congo red methyl methane sulfonate |
P M |
Precipitate Manual count |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without rat- and hamster S9
In conclusion, it can be stated that during the described mutage¬nicity 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 with and without rat and hamster S9. - Executive summary:
This study was performed to investigate the potential of FAT 41044/A TE to induce gene mutations according to the plate incorporation assay with rat liver S9 (experiment I), and the pre-incubation test with hamster liver S9 (experiment II) using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls, were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 100 to 5000 µg/plate in experiment I and from 1000 to 5000 µg/plate in experiment II. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 333 to 5000 µg/plate in both experiments. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred most of the strains. A minor reduction in the number of revertants (below the indication factor of 0.5) was observed in strains TA 1535 and TA 1537 in experiment I without S9 mix at 2500 µg/plate and in experiment II in strain TA 1537 in the absence of metabolic activation at 5000 µg/plate and in strain TA 1535 in the presence of metabolic activation at 5000 µg/plate.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with FAT 41044/A TE at any concentration 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.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
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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