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EC number: 700-503-1 | CAS number: 101238-01-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (21 Jul 1997)
- Deviations:
- yes
- Remarks:
- (2-aminoanthracene is the only indicator for the examination of the S9-capability)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (BASF SE, Experimental Toxicology and Ecology, Ludwigshafen, Germany)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2,6,6-tetramethylpiperidin-4-yl dodecanoate
- EC Number:
- 700-503-1
- Cas Number:
- 101238-01-1
- Molecular formula:
- C21 H41 N O2
- IUPAC Name:
- 2,2,6,6-tetramethylpiperidin-4-yl dodecanoate
- Details on test material:
- - Analytical purity: 94%
Constituent 1
Method
- Target gene:
- his+ / trp+
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and beta-naphthoflavone induced rat liver S9 microsomal fraction
- Test concentrations with justification for top dose:
- 1st Experiment (Standard plate test with and without S9 mix): 0, 33, 100, 333, 1000, 2500 and 5400 μg/plate (strong bacteriotoxicity was observed in the 1st standard plate test, therefore a second standard plate test with lower concentrations was conducted)
2nd Experiment (Standard plate test with and without S9 mix): 0, 0.1, 0.33, 1, 3.3, 10 and 33 μg/plate
3rd Experiment (Preincubation test with and without S9 mix): 0, 0.033, 0.1, 0.33, 1, 3.3 and 10 μg/plate (without S9 mix); 0, 0.1, 0.33, 1, 3.3, 10 and 33 μg/plate (with S9 mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in ultrapure water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA), N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 4-nitro-o-phenylenediamine (NOPD), 9-aminoacridine (AAC), 4-nitroquinoline-N-oxide (4-NQO)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
Standard plate test:
- Exposure duration: 48 – 72 hours
Preincubation test:
- Preincubation period: 20 min
- Exposure duration: 48 – 72 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn, reduction in the titer
OTHER:
Titer determination: The titer was determined only in the experimental parts with S9 mix both for the negative controls (vehicle only) and for the two highest doses in all experiments.
Positive controls:
With S9 mix: 2-aminoanthracene (2-AA), 2.5 μg/plate, dissolved in DMSO / TA 1535, TA 100, TA 1537, TA 98; 60 μg/plate, dissolved in DMSO / Escherichia coli WP2 uvrA
Without S9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), 5 μg/plate, dissolved in DMSO / TA 1535, TA 100; 4-nitro-o-phenylenediamine (NOPD), 10 μg/plate, dissolved in DMSO / TA 98; 9-aminoacridine (AAC), 100 μg/plate, dissolved in DMSO / TA 1537; 4-nitroquinoline-N-oxide (4-NQO) (SIGMA, N-8141), 5 μg/plate, dissolved in DMSO / E. coli WP2 uvrA - Evaluation criteria:
- Acceptance criteria:
Generally, the experiment is considered valid if the following criteria are met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 10^9 cells per mL were used. For approval the titer of viable bacteria was ≥ 10^8 colonies per mL.
Assessment criteria:
The test substance is considered positive in this assay if the following criteria are met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance is generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (SPT: 10 and 33 µg/plate (-S9), 33 µg/plate (+S9); PIT: 3.3 and 10 µg/plate (-S9), 10 and 33 µg/plate (+S9))
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found at 5400 μg/plate with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: A strong bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number
of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test and in the preincubation assay depending on the strain and test conditions from about 1 μg/plate onward. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Strong bacteriotoxicity was observed in the 1st standard plate test, therefore a second standard plate test with lower concentrations was conducted. The results of the second standard plate test and of the preincubation test are showen in the following tables:
Table 1. Test results of experiment 2 (standard plate test).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
TA 100 |
TA1535 |
E.coli WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 |
53 ± 3 |
10 ± 1 |
64 ± 5 |
18 ± 3 |
8 ± 1 |
– |
0.1 |
46 ± 9 |
9 ± 2 |
62 ± 6 |
17 ± 3 |
8 ± 0 |
– |
0.33 |
47 ± 5 |
10 ± 1 |
57 ± 8 |
17 ± 3 |
7 ± 1 |
– |
1 |
55 ± 14 |
10 ± 4 |
58 ± 3 |
16 ± 1 |
6 ± 1 |
– |
3.3 |
39 ± 2 |
9 ± 1 |
63 ± 12 |
16 ± 1 |
5 ± 2 |
– |
10 |
12 ± 1B |
4 ± 2B |
58 ± 5B |
10 ± 3B |
0B |
– |
33 |
0B |
0B |
22 ± 3B |
0B |
0B |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
4-NQO |
NOPD |
AAC |
Concentrations (μg/plate) |
5 |
5 |
5 |
10 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1595 ± 30 |
1018 ± 55 |
757 ± 84 |
940 ± 9 |
1019 ± 133 |
|
+ |
0 |
57 ± 6 |
11 ± 2 |
68 ± 4 |
23 ± 4 |
10 ± 1 |
+ |
0.1 |
56 ± 5 |
10 ± 2 |
63 ± 3 |
17 ± 3 |
10 ± 2 |
+ |
0.33 |
58 ± 9 |
12 ± 2 |
75 ± 4 |
25 ± 5 |
9 ± 2 |
+ |
1 |
55 ± 9 |
12 ± 2 |
69 ± 5 |
25 ± 5 |
8 ± 1 |
+ |
3.3 |
53 ± 3 |
13 ± 3 |
71 ± 5 |
24 ± 1 |
7 ± 0 |
+ |
10 |
53 ± 10 |
11 ± 1 |
67 ± 7 |
20 ± 5 |
9 ± 2 |
+ |
33 |
45 ± 7B |
11 ± 1B |
55 ± 5B |
23 ± 5B |
5 ± 3B |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
60 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1535 ± 41 |
228 ± 21 |
292 ± 10 |
1624 ± 60 |
204 ± 26 |
B = reduced background growth
Table 2. Test results of experiment 3 (preincubation test).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
TA 100 |
TA1535 |
E.coli WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 |
31 ± 2 |
11 ± 1 |
52 ± 2 |
16 ± 1 |
6 ± 1 |
– |
0.033 |
30 ± 2 |
10 ± 1 |
54 ± 2 |
15 ± 1 |
4 ± 1 |
– |
0.1 |
31 ± 2 |
10 ± 3 |
51 ± 6 |
19 ± 8 |
6 ± 1 |
– |
0.33 |
32 ± 3 |
8 ± 1 |
50 ± 6 |
17 ± 3 |
6 ± 1 |
– |
1 |
32 ± 3 |
11 ± 2 |
57 ± 6 |
10 ± 2 |
5 ± 1 |
– |
3.3 |
19 ± 3B |
7 ± 1B |
30 ± 3B |
11 ± 3B |
0B |
– |
10 |
0B |
0B |
15 ± 3B |
0B |
0B |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
4-NQO |
NOPD |
AAC |
Concentrations (μg/plate) |
5 |
5 |
5 |
10 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1009 ± 42 |
1113 ± 108 |
1305 ± 41 |
772 ± 73 |
669 ± 228 |
|
+ |
0 |
35 ± 4 |
11 ± 2 |
44 ± 6 |
21 ± 2 |
8 ± 2 |
+ |
0.1 |
38 ± 1 |
11 ± 2 |
39 ± 4 |
21 ± 1 |
9 ± 1 |
+ |
0.33 |
39 ± 9 |
11 ± 2 |
37 ± 5 |
18 ± 2 |
6 ± 1 |
+ |
1 |
37 ± 2 |
8 ± 2 |
40 ± 4 |
17 ± 3 |
7 ± 2 |
+ |
3.3 |
38 ± 1 |
9 ± 2 |
40 ± 3 |
19 ± 2 |
5 ± 1 |
+ |
10 |
37 ± 4B |
8 ± 3B |
40 ± 6B |
19 ± 4B |
5 ± 1B |
+ |
33 |
39 ± 1B |
11 ± 3B |
38 ± 6B |
18 ± 3B |
6 ± 3B |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
60 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
925 ± 32 |
148 ± 12 |
161 ± 13 |
1015 ± 15 |
169 ± 13 |
B = reduced background growth
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium / Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
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