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EC number: 277-620-5 | CAS number: 73833-37-1
- 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
- Study period:
- 2009 -06-22 till 2009-08-05
- 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:
- 2 009
- Report date:
- 2009
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
- Reference substance name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- EC Number:
- 277-620-5
- EC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- Cas Number:
- 73833-37-1
- Molecular formula:
- C22H40N2O2.xClH
- IUPAC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride
- Reference substance name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diaza-dispiro-[5.1.11.2]-heneicosan-21-one hydrochloride
- IUPAC Name:
- 2,2,4,4-tetramethyl-7-oxa-3,20-diaza-dispiro-[5.1.11.2]-heneicosan-21-one hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): 2,2,4,4-Tetramethyl-7-oxa-3,20-diaza-dispiro-
[5.1.11.2]-heneicosan-21-one hydrochloride
- Physical state: solid/ white
- Analytical purity: 96.6 % (w/w)
- Lot/batch No.: DEF2036584
- Expiration date of the lot/batch: May 07, 2018
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature
- Other: None
Constituent 1
Constituent 2
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
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
Experiment II
without S9 mix:
Salmonella strains: 0.063; 0.21; 0.63; 2.1; 6.25; 20.83; 62.5; 208.5; and 625 µg/plate
E. coli: 0.21; 0.63; 2.1; 6.25; 20.83; 62.5; 208.5; 625 and 2500 µg/plate
With S9 mix
all strains: 0.21; 0.63; 2.1; 6.25; 20.83; 62.5; 208.5; 625 and 2500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: better than others
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 medium; in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 1 hour
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
Precipitation of the test item (visible to the unaided eye) was observed in the overlay agar in the test tubes from 2500 µg/plate up to 5000 µg/plate in experiment I and at 2500 µg/plate in experiment II and on the incubated agar plates from 2500 µg/plate up to 5000 µg/plates in experiment I with and without metabolic activation. The undissolved particles had no influence on the data recording.
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 100 - 5000 333 - 5000 20.83 - 625 208.3 - 2500
TA 1537 100 - 5000 333 - 5000 62.5 - 625 208.3 - 2500
TA 98 100 - 5000 333 - 5000 62.5 - 625 208.3 - 2500
TA 100 100 - 5000 333 - 5000 20.83 - 625 208.3 - 2500
WP2 uvrA 1000 - 5000 1000 - 5000 208.3 - 2500 625 - 2500
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups at the following concentrations (µg/plate):
Strain Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 333 - 5000 333 - 5000 20.83 - 625 625 - 2500
TA 1537 333 - 5000 1000 - 5000 62.5 - 625 208.3 - 2500
TA 98 333 - 5000 333 - 5000 62.5 - 625 625 - 2500
TA 100 333 - 5000 333 - 5000 62.5 - 625 208.3 - 2500
WP2 uvrA 2500 - 5000 1000 - 5000 625 - 2500 2500 - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary Tabellen
Summary of Results Pre-Experiment and Experiment I
Study Name: 1268400 |
Study Code: Harlan -CCR 1268400 |
Experiment: 1268400 VV Plate |
Date Plated: 22/06/2009 |
Assay Conditions: |
Date Counted: 25/06/2009 |
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 |
13 ± 3 |
12 ± 3 |
35 ± 4 |
138 ± 5 |
55 ± 9 |
||
Untreated |
12 ± 4 |
10 ± 3 |
33 ± 6 |
141 ± 18 |
65 ± 24 |
|||
2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride |
3 µg |
13 ± 1 |
13 ± 4 |
30 ± 4 |
143 ± 10 |
63 ± 10 |
||
10 µg |
13 ± 1 |
12 ± 6 |
33 ± 4 |
138 ± 3 |
57 ± 7 |
|||
33 µg |
12 ± 2 |
14 ± 1 |
33 ± 10 |
144 ± 7 |
60 ± 9 |
|||
100 µg |
8 ± 1R |
10 ± 4R |
26 ± 6R |
81 ± 3R |
56 ± 7 |
|||
333 µg |
1 ± 1M R |
1 ± 1M R |
10 ± 3R |
16 ± 3M R |
49 ± 8 |
|||
1000 µg |
0 ± 0R |
0 ± 0R |
3 ± 1M R |
10 ± 5M R |
36 ± 6R |
|||
2500 µg |
0 ± 0R P |
0 ± 0P R |
0 ± 0P R M |
0 ± 0P M R |
2 ± 1P M R |
|||
5000 µg |
0 ± 0R P M |
0 ± 0P R M |
0 ± 0P M R |
0 ± 0P M R |
1 ± 1P M R |
|||
NaN3 |
10 µg |
2107 ± 188 |
1986 ± 24 |
|||||
4-NOPD |
10 µg |
321 ± 3 |
||||||
4-NOPD |
50 µg |
99 ± 33 |
||||||
MMS |
3.0 µL |
1047 ± 11 |
||||||
With Activation |
DMSO |
19 ± 5 |
17 ± 2 |
43 ± 10 |
167 ± 17 |
69 ± 4 |
||
Untreated |
22 ± 8 |
18 ± 6 |
41 ± 7 |
171 ± 6 |
64 ± 20 |
|||
2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride |
3 µg |
19 ± 5 |
16 ± 1 |
37 ± 1 |
151 ± 3 |
69 ± 17 |
||
10 µg |
19 ± 3 |
15 ± 2 |
39 ± 6 |
134 ± 7 |
72 ± 4 |
|||
33 µg |
30 ± 10 |
16 ± 4 |
42 ± 2 |
142 ± 14 |
68 ± 5 |
|||
100 µg |
21 ± 8 |
15 ± 4 |
40 ± 3 |
134 ± 21 |
69 ± 7 |
|||
333 µg |
6 ± 3R |
8 ± 3R |
18 ± 4R |
8 ± 2R M |
68 ± 18 |
|||
1000 µg |
1 ± 1M R |
2 ± 0M R |
3 ± 1M R |
3 ± 1M R |
28 ± 8R |
|||
2500 µg |
0 ± 0R P |
0 ± 0P R |
1 ± 0P R |
0 ± 0P M R |
1 ± 1P M R |
|||
5000 µg |
0 ± 0R P M |
0 ± 0P R M |
0 ± 0P M R |
0 ± 0P M R |
0 ± 0P M R |
|||
2-AA |
2.5 µg |
361 ± 39 |
181 ± 54 |
1504 ± 65 |
1786 ± 132 |
|||
2-AA |
10.0 µg |
241 ± 24 |
||||||
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 |
R M P |
Reduced background growth Manual count Precipitate |
Summary of Results Experiment II
Study Name: 1268400 |
Study Code: Harlan -CCR 1268400 |
Experiment: 1268400 HV2 Pre |
Date Plated: 02/07/2009 / 29/07/2009* |
Assay Conditions: |
Date Counted: 08/07/2009 / 05/08/2009* |
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 |
16 ± 4 |
8 ± 2 |
31 ± 3 |
131 ± 18 |
54 ± 3 |
||
Untreated |
12 ± 3 |
14 ± 7 |
34 ± 10 |
145 ± 8 |
64 ± 9 |
|||
2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride |
0.063 µg |
16 ± 4 |
10 ± 2 |
33 ± 7 |
125 ± 19 |
|||
0.21 µg |
17 ± 3 |
13 ± 1 |
26 ± 6 |
119 ± 6 |
48 ± 13 |
|||
0.63 µg |
15 ± 2 |
12 ± 3 |
32 ± 10 |
107 ± 2 |
52 ± 8 |
|||
2.1 µg |
16 ± 4 |
9 ± 0 |
30 ± 1 |
117 ± 9 |
55 ± 12 |
|||
6.25 µg |
13 ± 1 |
13 ± 3 |
31 ± 2 |
119 ± 9 |
52 ± 4 |
|||
20.83 µg |
7 ± 0R |
10 ± 4 |
30 ± 4 |
63 ± 5R |
58 ± 4 |
|||
62.5 µg |
4 ± 2M R |
3 ± 2M R |
5 ± 1M R |
17 ± 4M R |
54 ± 0 |
|||
208.3 µg |
0 ± 0R |
0 ± 0R |
0 ± 0R |
0 ± 0R |
28 ± 7R |
|||
625 µg |
0 ± 0R |
0 ± 0R |
0 ± 0R |
0 ± 0R |
23 ± 3R |
|||
2500 µg |
2 ± 2M R |
|||||||
NaN3 |
10 µg |
1749 ± 65 |
1749 ± 122 |
|||||
4-NOPD |
10 µg |
452 ± 12 |
||||||
4-NOPD |
50 µg |
99 ± 10 |
||||||
MMS |
3.0 µL |
493 ± 76 |
||||||
With Activation |
DMSO |
23 ± 4 |
17 ± 3 |
35 ± 1* |
138 ± 11 |
62 ± 5 |
||
Untreated |
21 ± 2 |
21 ± 1 |
38 ± 5* |
129 ± 17 |
55 ± 2 |
|||
2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride |
0.21 µg |
22 ± 4 |
19 ± 3 |
36 ± 2* |
128 ± 13 |
66 ± 2 |
||
0.63 µg |
23 ± 3 |
20 ± 6 |
40 ± 5* |
116 ± 9 |
56 ± 1 |
|||
2.1 µg |
22 ± 2 |
17 ± 3 |
33 ± 2* |
106 ± 10 |
60 ± 8 |
|||
6.25 µg |
22 ± 2 |
17 ± 3 |
33 ± 3* |
116 ± 12 |
64 ± 8 |
|||
20.83 µg |
24 ± 4 |
17 ± 2 |
37 ± 7* |
121 ± 9 |
64 ± 3 |
|||
62.5 µg |
20 ± 4 |
17 ± 1 |
38 ± 10* |
97 ± 9 |
57 ± 12 |
|||
208.3 µg |
11 ± 3R |
3 ± 2M R |
20 ± 1R* |
21 ± 4M R |
55 ± 3 |
|||
625 µg |
3 ± 2M R |
1 ± 1M R |
0 ± 0M R* |
9 ± 6M R |
42 ± 8R |
|||
2500 µg |
1 ± 1M R |
0 ± 0M R |
0 ± 0M R * |
0 ± 0M R |
5 ± 2M R |
|||
2-AA |
2.5 µg |
245 ± 12 |
110 ± 22 |
1416 ± 220* |
1332 ± 53 |
|||
2-AA |
10.0 µg |
349 ± 30 |
||||||
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 |
R M |
Reduced background growth Manual count |
* = repeated experiment
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without S9 mix
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. - Executive summary:
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with 2,2,4,4-Tetramethyl-7-oxa-3,20-diaza-dispiro-[5.1.11.2]-heneicosan-21-one hydrochloride 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.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.
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