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EC number: 938-458-7 | CAS number: 1443751-77-6
- 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
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:
- May 24 - June 21, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1443751-77-6
- Cas Number:
- 1443751-77-6
- IUPAC Name:
- 1443751-77-6
- Reference substance name:
- Amides, C8-10, N-(hydroxyethyl)
- IUPAC Name:
- Amides, C8-10, N-(hydroxyethyl)
Constituent 1
Constituent 2
Method
- Target gene:
- his and trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: agar medium contained: 7 g/L purified agar, 6 g/L NaCl. The agar plates also contained 12.2 mg/l biotin and 10.5 mg/l histidine.
Strains were regularly checked to confirm their histidine-requirement, crystal violet sensitivity, ampicillin resistance (TA98 and TA100), UV-sensitivity and the number of spontaneous revertants.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Agar medium contained: 7 g/L purified agar, 6 g/L NaCl. The agar plates also contained 10.2 mg/l tryptophan.
The sensitivity of the strain to a wide variety of mutagens was enhanced by permeabilization of the strain using Tris-EDTA treatment. The strain was regularly checked to confirm the tryptophan-requirement, UV-sensitivity and the number of spontaneous revertants.
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Phenobarbital/-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1 : 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate in the presence and abscence of S9-mix (all strains);
Experiment 2:
without S9 mix:
Salmonella strains: 0.3; 1; 3; 10; 33; 100; 333; and 1000 µg/plate
WP2 uvrA: 1; 3; 10; 33; 100; 333; 1000, and 2500 µg/plate
with S9 mix all strains: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (test substance), DMSO and deionised water (positive controls)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see "Details on test system and conditions"
- Details on test system and experimental conditions:
- Positive control substances:
-S9: sodium azide (10 μg/plate in deionised water) for TA1535 and TA100; 4-nitro-o-phenylene-diamine (10 μg/plate in DMSO) for TA98; 4-nitro-o-phenylene-diamine (50 μg/plate in DMSO) for TA1537; methylmethanesulfonate (3.0 μg/plate in deionised water) for WP2uvrA
+S9: 2-aminoanthracene in DMSO for all strains (TA1535, TA1537, TA98, TA100: 2.5 µg/plate; WP2uvrA: 10 µg/plate)
METHOD OF APPLICATION: in agar (plate incorporation and pre-incubation)
DURATION
- Exposure duration: 48 ± 4h at 37°C in the dark
NUMBER OF REPLICATIONS: 3 replications for each experiment
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test substance was considered negative (not mutagenic) in the test if:
The total number of revertants in tester strains TA 98, TA 100, and WP2 uvrA was not greater than two times the concurrent control, and the total number of revertants in tester strains TA 1535 and TA 1537 was not greater than three times the concurrent vehicle control.
The negative response was reproducible in at least one independently repeated experiment.
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 (3).
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration (2).
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.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100; E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- see "Additional information on results"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: yes
RANGE-FINDING/SCREENING STUDIES: In a dose range finding test (reported as part of experiment 1), the test substance was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in all. The test substance precipitated on the plates at the highest dose level.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups.
In tester strains TA1535 and TA98, toxicity was observed at dose levels of 333-5000 μg/plate in the absence of S9-mix and at 2500-5000 µg/plate in the presence of S9-mix. In tester strains TA1537 and TA100, toxicity was observed at dose levels of 333-5000 μg/plate in the absence of S9-mix and at 2500-5000 µg/plate in the presence of S9-mix. In tester strain WP2uvrA toxicity was observed at dose levels of 2500-5000 μg/plate in the absence of S9-mix and at 5000 µg/plate in the presence of S9-mix.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In experiment 2, cytotoxicity was observed in tester strains TA1535, TA98 and TA100 at dose levels of 333-1000 μg/plate in the absence of S9-mix and at 21000-5000 µg/plate in the presence of S9-mix. In tester strain TA1537, toxicity was observed at dose levels of 100-1000 μg/plate in the absence of S9-mix and at 1000-5000 µg/plate in the presence of S9-mix. In tester strain WP2uvrA toxicity was observed at dose levels of 1000-2500 μg/plate in the absence of S9-mix and at dose levels of 2500-5000 µg/plate in the presence of S9-mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 (Experiment 1): Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain (the S9 -mix contained 5% (v/v) S9 fraction)
Dose (µg/plate) |
S9-mix |
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Positive control |
- |
1328 ± 77 |
66 ± 3 |
363 ± 23 |
1266 ± 64 |
774 ± 36 |
Solvent control |
- |
15 ± 3 |
14 ± 1 |
30 ± 2 |
138 ± 6 |
60 ± 11 |
Untreated |
- |
20 ± 1 |
13 ± 3 |
31 ± 6 |
159 ± 6 |
60 ± 5 |
3 |
- |
19 ± 3 |
14 ± 2 |
26 ± 7 |
130 ± 18 |
53 ± 7 |
10 |
- |
16 ± 2 |
14 ± 2 |
26 ± 3 |
145 ± 11 |
63 ± 11 |
33 |
- |
14 ± 3 |
14 ± 2 |
29 ± 2 |
130 ± 25 |
64 ± 6 |
100 |
- |
15 ± 4 |
12 ± 2 |
33 ± 4 |
108 ± 19 |
57 ± 9 |
333 |
- |
4 ± 2M R |
2 ± 1 M R |
19 ± 5M R |
17 ± 3M R |
47 ± 8 |
1000 |
- |
0 ± 0 R |
0 ± 0 R |
3 ± 1M R |
2 ± 1M R |
51 ± 2 |
2500 |
- |
0 ± 0 R |
0 ± 0 R |
0 ± 0 R |
0 ± 0 R |
6 ± 2 M R |
5000 |
- |
0 ± 0 P R |
0 ± 0 P R |
0 ± 0 P R |
0 ± 0 P R |
0 ± 0 P R |
Positive control |
+ |
317 ± 24 |
196 ± 20 |
1851 ± 498 |
2056 ± 26 |
334 ± 20 |
Solvent control |
+ |
21 ± 2 |
21 ± 3 |
39 ± 6 |
173 ± 6 |
70 ± 9 |
Untreated |
+ |
25 ± 3 |
27 ± 1 |
47 ± 7 |
164 ± 6 |
71 ± 8 |
3 |
+ |
22 ± 1 |
24 ± 6 |
48 ± 4 |
147 ± 8 |
57 ± 8 |
10 |
+ |
25 ± 2 |
26 ± 6 |
36 ± 4 |
161 ± 27 |
63 ± 2 |
33 |
+ |
21 ± 4 |
22 ± 4 |
41 ± 8 |
157 ± 24 |
72 ± 5 |
100 |
+ |
24 ± 5 |
23 ± 1 |
45 ± 3 |
162 ± 25 |
68 ± 8 |
333 |
+ |
22 ± 7 |
26 ± 3 |
47 ± 10 |
147 ± 17 |
61 ± 10 |
1000 |
+ |
12 ± 2 |
9 ± 1 R |
34 ± 6 |
62 ± 5 R |
54 ± 8 |
2500 | + | 3 ± 1 MR | 0 ± 1 MR | 6 ± 2 MR | 0 ± 1 R | 23 ± 5 |
5000 | + | 0 ± 0 PMR | 0 ± 0 PMR | 0 ± 0 PMR | 0 ± 0 PMR | 4 ± 2 PMR |
(testing 3-5000 µg/plate in all strains represent the dose-range finding test of the study and were reported as the first experiment)
solvent control: DMSO
M: Manual count
R: Reduced background growth
P: Precipitate
Table 2 (Experiment 2): Mean number of revertant colonies/3 replicate plates (± S.D.) with two strains of Salmonella typhimurium
and one Escherichia coli strain (the S9 -mix contained 5% (v/v) S9 fraction)
Dose (µg/plate) |
S9-mix |
TA1535 |
TA1537 |
TA98 | TA100 | WP2uvrA |
Positive control |
- |
2020 ± 123 |
94 ± 15 |
424 ± 19 | 2049 ± 57 | 481 ± 24 |
Solvent control |
- |
17 ± 5 |
22 ± 5 |
26 ± 1 | 118 ± 12 | 59 ± 6 |
Untreated |
- |
14 ± 5 |
17 ± 7 |
25 ± 3 | 154 ± 7 | 63 ± 3 |
0.3 |
- |
16 ± 3 |
18 ± 4 |
25 ± 3 | 112 ± 12 | |
1 |
- |
14 ± 3 |
19 ± 2 |
28 ± 5 | 132 ± 9 | 63 ± 11 |
3 |
- |
15 ± 5 |
17 ± 3 |
24 ± 4 | 119 ± 1 | 62 ± 8 |
10 |
- |
20 ± 6 |
18 ± 4 |
21 ± 1 | 120 ± 2 | 59 ± 3 |
33 |
- |
9 ± 2 |
17 ± 4 |
26 ± 6 | 110 ± 4 | 70 ± 5 |
100 |
- |
10 ± 2 |
2 ± 1 M R |
16 ± 3 | 57 ± 8 M R | 49 ± 9 |
333 |
- |
1 ± 1 M R |
1 ± 1 M R |
3 ± 1 M R | 36 ± 5 M R | 50 ± 1 |
1000 |
- |
0 ± 0 M R |
0 ± 0 M R |
0 ± 0 M R | 0 ± 0 M R | 9 ± 2 M R |
2500 |
- |
0 ± 0 M R | ||||
Positive control |
+ |
294 ± 23 |
216 ± 9 |
1380 ± 66 | 1813 ± 49 | 280 ± 14 |
solvent control |
+ |
18 ± 5 |
23 ± 3 |
31 ± 6 | 147 ± 20 | 62 ± 4 |
Untreated |
+ |
22 ± 3 |
27 ± 3 |
45 ± 12 | 194 ± 15 | 70 ± 3 |
3 |
+ |
20 ± 1 |
22 ± 0 |
36 ± 6 | 130 ± 6 | 67 ± 2 |
10 | + | 17 ± 1 | 27 ± 3 | 38 ± 5 | 143 ± 14 | 69 ± 11 |
33 | + | 20 ± 7 | 22 ± 8 | 32 ± 5 | 152 ± 13 | 64 ± 9 |
100 | + | 23 ± 3 | 23 ± 3 | 33 ± 8 | 160 ± 18 | 72 ± 7 |
333 | + | 21 ± 1 | 24 ± 2 | 34 ± 5 | 132 ± 13 | 80 ± 6 |
1000 | + | 5 ± 1 M R | 4 ± 1 M R | 7 ± 2 M R | 13 ± 2 M R | 52 ± 8 |
2500 | + | 0 ± 0 M R | 0 ± 0 M R | 2 ± 0 M R | 0 ± 0 M R | 10 ± 1 R |
5000 | + | 0 ± 0 P M R | 0 ± 0 P M R | 0 ± 0 P M R | 0 ± 0 P M R | 0 ± 0 P M R |
solvent control: DMSO
M: Manual count
R: Reduced background growth
P: Precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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