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EC number: 204-436-4 | CAS number: 120-93-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-imidazolidone
- EC Number:
- 204-436-4
- EC Name:
- 2-imidazolidone
- Cas Number:
- 120-93-4
- Molecular formula:
- C3H6N2O
- IUPAC Name:
- 2-imidazolidone
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 74-7718
- Test substance No.: 89/91
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254
- Test concentrations with justification for top dose:
- - first test: 20, 100, 500, 2500 and 5000 µg/plate (standard plate test; all test strains)
- second test: 200, 400, 600, 800 and 1000 µg/plate (standard plate test; test strain TA98)
- third test: 20, 100, 500, 2500 and 5000 µg/plate (preincubation test; all test strains)
- fourth test: 4, 20, 100, 500 and 2500 µg/plate (preincubation test; test strain TA98) - Vehicle / solvent:
- aqua dest.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - S9: aminoanthracene (2-AA): all test strains; + S9: methyl-N-nitro-N-nitrosoguanidine (MNNG): TA100 and TA1535, 4-nitro-o-phenylendiamine (NPD): TA98 and 9-aminoacridine chloride monohydrate (AAC): TA1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
Plate incorcoration method:
- Exposure duration: ca. 48-72 hours at 37 °C in the dark
Preincubation method:
- Preincubation period: 20 minutes at 37 °C
- Exposure duration: ca. 48-72 hours at 37 °C in the dark
NUMBER OF REPLICATIONS:
- 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Decrease in the number of revertants
- Reduced his- or trp- background growth
- Reduction in the titer - Evaluation criteria:
- In order to characterized a substance as positive in the Ames test it has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control);
- dose-response relationship;
- reproducibility of the results.
Results and discussion
Test results
- Key result
- 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
- Additional information on results:
- Toxicity:
No bacteriotoxic effect (reduced his- background growth) was observed.
Solubility:
Complete solubility of test substance in aqua dest.
Any other information on results incl. tables
Table 1: Standard Plate Test (TA 98)
Dose [µg/plate] |
TA 98 Mean ± SD |
Without S9 mix |
|
Negative control (aqua dest) |
28 ± 5 |
200 |
33 ± 12 |
400 |
26 ± 4 |
600 |
24 ± 5 |
800 |
20 ± 2 |
1000 |
26 ± 4 |
10 NPD |
1118 ± 125 |
With S9 mix |
|
Negative control (aqua dest) |
44 ± 4 |
200 |
38 ± 4 |
400 |
40 ± 3 |
600 |
36 ± 1 |
800 |
39 ± 3 |
1000 |
30 ± 11 |
10 2-AA |
1850 ± 26 |
Table 2: Standard Plate Test (TA 98, TA 100, TA 1535, TA 1537)
Dose [µg/plate] |
TA 98 Mean ± SD |
TA 100 Mean ± SD |
TA 1535 Mean ± SD |
TA1537 Mean ± SD |
Without S9 mix |
||||
Negative control (aqua dest) |
28 ± 2 |
140 ± 5 |
19 ± 6 |
15 ± 4 |
20 |
33 ± 5 |
129 ± 8 |
24 ± 3 |
10 ± 4 |
100 |
33 ± 3 |
131 ± 27 |
19 ± 1 |
15 ± 4 |
500 |
38 ± 11 |
99 ± 8 |
22 ± 5 |
13 ± 5 |
2500 |
26 ± 6 |
114 ± 6 |
22 ± 4 |
10 ± 5 |
5000 |
23 ± 7 |
139 ± 5 |
23 ± 4 |
10 ± 3 |
10 NPD |
922 ± 88 |
|
|
|
100 AAC |
|
|
|
430 ± 91 |
5 MNNG |
|
1347 ± 43 |
1349 ± 273 |
|
With S9 mix |
||||
Negative control (aqua dest) |
41 ± 5 |
122 ± 13 |
20 ± 11 |
14 ± 2 |
20 |
57 ± 5 |
139 ± 6 |
21 ± 4 |
15 ± 5 |
100 |
54 ± 12 |
126 ± 4 |
18 ± 2 |
15 ± 7 |
500 |
62 ± 23 |
137 ± 16 |
20 ± 4 |
21 ± 1 |
2500 |
36 ± 9 |
140 ± 45 |
19 ± 4 |
20 ± 8 |
5000 |
36 ± 10 |
117 ± 30 |
18 ± 1 |
16 ± 3 |
10 2-AA |
785 ± 62 |
334 ± 47 |
379 ± 53 |
96 ± 15 |
Table 3: Preincubation Test (TA 98)
Dose [µg/plate] |
TA 98 Mean ± SD |
Without S9 mix |
|
Negative control (aqua dest) |
26 ± 2 |
4 |
23 ± 2 |
20 |
26 ± 2 |
100 |
21 ± 2 |
500 |
27 ± 1 |
2500 |
26 ± 2 |
10 NPD |
1120 ± 98 |
With S9 mix |
|
Negative control (aqua dest) |
41 ± 4 |
4 |
39 ± 6 |
20 |
34 ± 13 |
100 |
35 ± 13 |
500 |
38 ± 6 |
2500 |
33 ± 4 |
10 2-AA |
1247 ± 87 |
Table 4: Preincubation Test (TA 98, TA 100, TA 1535, TA 1537)
Dose [µg/plate] |
TA 98 Mean ± SD |
TA 100 Mean ± SD |
TA 1535 Mean ± SD |
TA 1537 Mean ± SD |
Without S9 mix |
||||
Negative control (aqua dest) |
24 ± 4 |
104 ± 11 |
14 ± 3 |
12 ± 2 |
20 |
39 ± 2 |
117 ± 16 |
15 ± 3 |
12 ± 2 |
100 |
36 ± 3 |
95 ± 15 |
16 ± 2 |
14 ± 1 |
500 |
38 ± 6 |
95 ± 5 |
16 ± 6 |
9 ± 4 |
2500 |
39 ± 9 |
115 ± 13 |
19 ± 3 |
13 ± 2 |
5000 |
31 ± 2 |
118 ± 11 |
14 ± 2 |
11 ± 2 |
10 NPD |
1320 ± 131 |
|
|
|
100 AAC |
|
|
|
313 ± 36 |
5 MNNG |
|
1343 ± 81 |
1317 ± 6 |
|
With S9 mix |
||||
Negative control (aqua dest) |
35 ± 3 |
113 ± 19 |
17 ± 6 |
12 ± 1 |
20 |
59 ± 20 |
126 ± 12 |
18 ± 2 |
14 ± 2 |
100 |
51 ± 10 |
148 ± 18 |
19 ± 1 |
11 ± 1 |
500 |
49 ± 4 |
129 ± 18 |
14 ± 2 |
14 ± 5 |
2500 |
48 ± 5 |
126 ± 21 |
17 ± 2 |
20 ± 3 |
5000 |
46 ± 3 |
135 ± 10 |
17 ± 2 |
19 ± 1 |
10 2-AA |
865 ± 241 |
886 ± 63 |
167 ± 11 |
141 ± 22 |
2 -AA: 2 -aminoanthracene
MNNG: N-methyl-N-nitro-N-nitroso-guanidine
NPD: 4 -nitro-o-phenylendiamine
AAC: 9 -aminoacridine chloride monohydrate
Applicant's summary and conclusion
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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