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EC number: 205-444-0 | CAS number: 140-95-4
- 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
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 September 2016 to 28 September 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2013
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3-bis(hydroxymethyl)urea
- EC Number:
- 205-444-0
- EC Name:
- 1,3-bis(hydroxymethyl)urea
- Cas Number:
- 140-95-4
- Molecular formula:
- C3H8N2O3
- IUPAC Name:
- 1,3-bis(hydroxymethyl)urea
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- All Salmonella typhimurium strains contained mutations in the histidine operon.
Escherichia coli WP2 uvrA carried a defect in one of the genes for tryptophan biosynthesis.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver metabolising system (S9 mix)
- Test concentrations with justification for top dose:
- The test material concentrations used were selected according to the EEC, OECD and Japanese guidelines for this test system. A maximum concentration of 5000 µg/plate was selected, in order that initial treatments were performed up to the maximum recommended concentration according to current regulatory guidelines (OECD, 1997).
- Vehicle / solvent:
- - Solvent used: water
- Justification for choice of solvent/vehicle: The selection of the solvent for this assay was undertaken based on the available information from the preliminary solubility test. Ultra pure water showed best performance and was thus used for this experiment at a maximum concentration of 100 µL/plate.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ultra pure water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- cumene hydroperoxide
- other: 2-Aminoanthracene (2-AA); Daunomycin (DAUN)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:plate incorporation
DURATION
- Exposure duration: 2-3 days
NUMBER OF REPLICATIONS: 3 for each test concentration and positive control, 6 for solvent control
DETERMINATION OF CYTOTOXICITY
- Method: reduction of background growth
- OTHER:
Counting of revertant colonies:
Revertant colonies were either scored automatically with the „Sorcerer" or manually with the validated „Ames Study Manager" from Perceptive Instruments, Haverhill, Suffolk, UK. Tables of individual and mean values were generated automatically.
The presence of a background lawn of non-revertant cells was checked for each plate. - Evaluation criteria:
- The assessment of test material-induced effects was dependent on the number of spontaneous revertants of each bacterial strain (solvent controls) and the increase in the number of revertants at the test material concentration which showed the highest number of colonies.
A test material was to be defined as negative or non-mutagenic in this assay if the assay was to be considered valid, and "no" or "weak increases" occurred in the test series performed ("weak increases" randomly occur due to experimental variation)
For valid data, the test material was considered to be positive or mutagenic if a dose dependent (over at least two test material concentrations) increase in the number of revertants was induced, the maximal effect was a "clear increase", and the effects were reproduced at similar concentration levels in the same test system, or "clear increases" occurred at least at one test material concentration, higher concentrations showed strong precipitation or cytotoxicity, and the effects were reproduced at the same concentration level in the same test system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2810 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2810 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2810 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2810 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 2810 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test material on the agar plates occurred.
HISTORICAL CONTROL DATA
Observed colony number remained mostly within the historical control values. Values outside those ranges remained without any biological significance.
Any other information on results incl. tables
Table 1: Summary of Series 1
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
|||||
TA 98 |
TA 100 |
TA 102 |
TA1535 |
TA 1537 |
WP2 uvrA |
|
Results without S9 |
||||||
Water |
30 ± 5 |
102 ± 9 |
221 ± 19 |
21 ± 4 |
29 ± 4 |
36 ± 8 |
5 |
35 ± 6 |
100 ± 22 |
239 ± 47 |
22 ± 6 |
24 ± 6 |
36 ± 7 |
15.8 |
30 ± 4 |
115 ± 9 |
251 ± 37 |
25 ± 5 |
32 ± 5 |
34 ± 8 |
50 |
30 ± 8 |
116 ± 5 |
252 ± 52 |
25 ± 3 |
36 ± 5 |
36 ± 10 |
158 |
30 ± 7 |
102 ± 12 |
234 ± 44 |
22 ± 1 |
30 ± 5 |
38 ± 8 |
500 |
26 ± 6 |
108 ± 7 |
245 ± 21 |
22 ± 2 |
28 ± 8 |
32 ± 7 |
1580 |
28 ± 4 |
119 ± 13 |
352 ± 19 |
32 ± 9 |
25 ± 6 |
44 ± 9 |
5000 |
1 ± 1 |
1 ± 2 |
3 ± 2 |
1 ± 0 |
0 ± 1 |
42 ± 9 |
DAUN (1.0) |
117 ± 12 |
|||||
NaN3 (2.0) |
1446 ± 137 |
903 ± 15 |
||||
CUM (200) |
757 ± 15 |
|||||
9-AA (50) |
1056 ± 286 |
|||||
NQO (2.0) |
1509 ± 148 |
|||||
Results with S9 |
||||||
Water |
44 ± 6 |
125 ± 11 |
382 ± 33 |
24 ± 8 |
29 ± 4 |
43 ± 6 |
5 |
30 ± 8 |
133 ± 40 |
397 ± 41 |
27 ± 6 |
23 ± 4 |
37 ± 3 |
15.8 |
29 ± 5 |
126 ± 8 |
389 ± 27 |
27 ± 4 |
31 ± 5 |
40 ± 2 |
50 |
38 ± 2 |
123 ± 18 |
420 ± 26 |
21 ± 7 |
27 ± 14 |
46 ± 13 |
158 |
34 ± 5 |
136 ± 10 |
417 ± 26 |
25 ± 5 |
29 ± 2 |
33 ± 4 |
500 |
32 ± 3 |
116 ± 23 |
430 ± 18 |
29 ± 5 |
32 ± 3 |
49 ± 7 |
1580 |
31 ± 12 |
127 ± 8 |
458 ± 6 |
25 ± 7 |
26 ± 8 |
42 ± 40 |
5000 |
4 ± 3 |
9 ± 4 |
49 ± 10 |
1 ± 1 |
8 ± 6 |
48 ± 4 |
2-AA (2.0) |
763 ± 47 |
1669 ± 146 |
||||
2-AA (5.0) |
254 ± 17 |
556 ± 58 |
||||
2-AA (10) |
512 ± 20 |
|||||
B(a)p (10) |
1897 ± 213 |
Table 2: Summary of Series 2
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli |
|||||
TA 98 |
TA 100 |
TA 102 |
TA1535 |
TA 1537 |
WP2 uvrA |
|
Results without S9 |
||||||
Water |
33 ± 7 |
117 ± 18 |
277 ± 16 |
30 ± 7 |
30 ± 3 |
30 ± 7 |
50 |
31 ± 3 |
124 ± 2 |
300 ± 32 |
27 ± 4 |
30 ± 4 |
36 ± 8 |
158 |
29 ± 5 |
126 ± 11 |
303 ± 15 |
18 ± 3 |
35 ± 3 |
31 ± 6 |
500 |
34 ± 7 |
117 ± 6 |
361 ± 39 |
28 ± 2 |
29 ± 3 |
35 ± 11 |
889 |
41 ± 11 |
118 ± 13 |
368 ± 16 |
30 ± 2 |
29 ± 6 |
34 ± 6 |
1580 |
30 ± 7 |
125 ± 7 |
476 ± 33 |
20 ± 2 |
28 ± 6 |
30 ± 3 |
2810 |
29 ± 6 |
117 ± 16 |
316 ± 96 |
18 ± 8 |
19 ± 4 |
42 ± 12 |
DAUN (1.0) |
296 ± 29 |
|||||
NaN3 (2.0) |
1709 ± 62 |
945 ± 27 |
||||
CUM (200) |
894 ± 90 |
|||||
9-AA (50) |
1639 ± 183 |
|||||
NQO (2.0) |
1608 ± 45 |
|||||
Results with S9 |
||||||
Water |
39 ± 9 |
132 ± 13 |
250 ± 28 |
24 ± 4 |
32 ± 3 |
37 ± 7 |
50 |
40 ± 8 |
143 ± 12 |
282 ± 55 |
24 ± 4 |
40 ± 4 |
39 ± 2 |
158 |
37 ± 11 |
140 ± 13 |
290 ± 31 |
25 ± 2 |
25 ± 8 |
41 ± 3 |
500 |
34 ± 11 |
139 ± 11 |
315 ± 37 |
24 ± 1 |
36 ± 5 |
43 ± 3 |
889 |
37 ± 2 |
130 ± 5 |
297 ± 41 |
24 ± 3 |
40 ± 6 |
38 ± 2 |
1580 |
29 ± 7 |
125 ± 11 |
414 ± 49 |
21 ± 8 |
29 ± 1 |
42 ± 8 |
2810 |
19 ± 6 |
129 ± 18 |
571 ± 72 |
22 ± 3 |
47 ± 6 |
48 ± 7 |
2-AA (2.0) |
193 ± 43 |
|||||
2-AA (5.0) |
1499 ± 61 |
|||||
2-AA (10) |
160 ± 1 |
341 ± 17 |
149 ± 12 |
|||
B(a)p (10) |
1176 ± 45 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions the test substance was considered mutagenic in the bacterial reverse mutation assay.
- Executive summary:
A study was conducted to investigate the test material for mutagenic potential in a bacterial reverse gene mutation assay in the absence and in the presence of a rat liver metabolising system (S9 mix) according to OECD 471. The investigations for the mutagenic potential of the test item were performed using Salmonella typhimurium tester strains TA 98, TA 100, TA102, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. In this study, two experimental series were performed. In the two series with S9 mix, 10 % and 30 % S9 in the S9 mix were used in the 1st and 2nd series, respectively. Vehicle and positive control treatments were included for all strains. The mean numbers of revertant colonies all fell within acceptable ranges for vehicle control treatments, and were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. Following test item treatments of all the tester strains in the absence and presence of S9 mix, a relevant dose dependent clear increase in revertant numbers was observed in Salmonella typhimurium TA 102 in the presence of S9 mix. It was concluded that the test item was mutagenic under the experimental conditions described.
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