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EC number: 214-478-5 | CAS number: 1132-61-2
- 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
- Study period:
- 2003-09-30 to 2003-10-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-morpholinopropanesulphonic acid
- EC Number:
- 214-478-5
- EC Name:
- 4-morpholinopropanesulphonic acid
- Cas Number:
- 1132-61-2
- Molecular formula:
- C7H15NO4S
- IUPAC Name:
- 3-morpholin-4-ylpropane-1-sulfonic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
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:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 :
obtained by RCC, Roßdorf
- method of preparation of S9 mix:
producted from the livers of male Wistar rats which were treated with 80 mg Phenobarbital/kg bw intraperitoneally; on the following day, with 80 mg beta-Naphthoflavon/kg bw orally
- concentration or volume of S9 mix and S9 in the final culture medium : 1 mL, 4 %
- quality controls of S9: no data - Test concentrations with justification for top dose:
- First experiment: 0.05.; 0.15; 0.5; 1.5; 5.0 mg/plate, where 5 mg/plate is the recommended maximum test concentration for soluble non-cytotoxic substances
Second experiment: 1.25; 2.5; 5.0 mg/plate, where 5 mg/plate is the recommended maximum test concentration for soluble non-cytotoxic substances - Vehicle / solvent:
- - solvent used: water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene diamine
- Remarks:
- without metabolic activation, TA97, TA98, TA102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation, TA100, TA 1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation, TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with metabolic activation, TA97, TA 100, TA102 and TA1535
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 4
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation); preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 20 min
- Exposure duration: 48 h (both experiments)
DETERMINATION OF CYTOTOXICITY
- Method: titre ratio - Evaluation criteria:
- A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor > 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
- Statistics:
- none
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium 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
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test item is soluble in deionised water. A stock solution containing 50 g/L was prepared.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : The treatments for the confirmation of the genotype, the sterility control and the determination of the titre didn't show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.
Ames test:
- Signs of toxicity :
No signs of toxicity towards the tested strains could be observed. The determined values for the toxicity control were in the range of the titre. The background lawn was visible and the number of revertant colonies was not reduced.
- Individual plate counts :
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
- Mean number of revertant colonies per plate and standard deviation :
see tables
HISTORICAL CONTROL DATA
- no data reported
Any other information on results incl. tables
Table with results for 1st Experiment (plate incorporation)
strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
water |
mean |
83 |
66 |
19 |
23 |
144 |
145 |
144 |
131 |
14 |
17 |
sd |
43.3 |
52.2 |
11.8 |
3.5 |
17 |
11 |
28.1 |
29.1 |
7.2 |
5.0 |
|
DMSO |
mean |
78 |
112 |
18 |
21 |
126 |
130 |
123 |
134 |
12 |
11 |
sd |
66.9 |
24.5 |
2.2 |
4.5 |
4 |
26 |
6.8 |
12.4 |
2.8 |
3.9 |
|
pos.contr. |
mean |
924 |
560 |
1038 |
70 |
633 |
754 |
656 |
717 |
590 |
439 |
sd |
103 |
126 |
221 |
25 |
163 |
256 |
32 |
184 |
76,1 |
49 |
|
f(I) |
11.9 |
5.0 |
57.7 |
3.4 |
4.4 |
5.8 |
5.3 |
5.4 |
42.9 |
40.8 |
|
5 mg/pl. |
mean |
79 |
116 |
13 |
16 |
136 |
148 |
129 |
141 |
12 |
12 |
sd |
86 |
78 |
5 |
7 |
28 |
18 |
11 |
13 |
2 |
4 |
|
f(I) |
0.95 |
1.75 |
0.69 |
0.70 |
0.94 |
1.02 |
0.90 |
1.07 |
0.89 |
0.7 |
|
1.5 mg/pl. |
mean |
61 |
62 |
16 |
13 |
121 |
104 |
101 |
81 |
10 |
13 |
sd |
50 |
48 |
3 |
4 |
14 |
20 |
11 |
10 |
6 |
2 |
|
f(I) |
0.73 |
0.94 |
0.83 |
0.58 |
0.84 |
0.72 |
0,70 |
0,62 |
0,73 |
0,77 |
|
0.5 mg/pl. |
mean |
91 |
52 |
14 |
13 |
129 |
83 |
102 |
65 |
14 |
18 |
sd |
11 |
53 |
3 |
3 |
23 |
25 |
10 |
5 |
1 |
1 |
|
f(I) |
1.10 |
0.78 |
0.73 |
0.59 |
0.90 |
0.57 |
0.71 |
0.49 |
1.00 |
1.03 |
|
0.15 mg/pl. |
mean |
73 |
59 |
18 |
16 |
71 |
74 |
107 |
57 |
11 |
12 |
sd |
37 |
39 |
4 |
3 |
14 |
11 |
20 |
10 |
4 |
1 |
|
f(I) |
0.88 |
0.90 |
0.95 |
0.69 |
0.49 |
0.51 |
0,74 |
0,43 |
0,76 |
0.67 |
|
0.05 mg/pl. |
mean |
90 |
87 |
15 |
16 |
127 |
101 |
117 |
72 |
14 |
16 |
sd |
17 |
24 |
2 |
5 |
41 |
21 |
11 |
17 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|||
f(I) |
1.08 |
1.32 |
0.75
|
0.72
|
0.88
|
0.70 |
0.82
|
0.54
|
1.02
|
0.90
|
Table with results for 2nd Experiment (pre-incubation)
strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
water |
mean |
149 |
117 |
10 |
11 |
131 |
120 |
128 |
119 |
10 |
10 |
sd |
55.1 |
67.9 |
2.1 |
2.6 |
22 |
18 |
16.8 |
7.5 |
2.6 |
2.2 |
|
DMSO |
mean |
93 |
118 |
9 |
11 |
93 |
96 |
119 |
116 |
8 |
11 |
sd |
67.8 |
18.6 |
2.5 |
4.1 |
28 |
6 |
36.8 |
11.9 |
1.7 |
2.6 |
|
pos.contr. |
mean |
571 |
721 |
604 |
61 |
948 |
575 |
847 |
678 |
1024 |
223 |
sd |
275 |
198 |
121 |
6 |
153 |
236 |
62 |
173 |
157 |
11 |
|
f(I) |
6.17 |
6.14 |
65.3 |
5.40 |
7.24 |
5.98 |
7.12 |
5.84 |
98.9 |
19.8 |
|
5 mg/pl. |
mean |
93 |
110 |
6 |
8 |
122 |
129 |
131 |
121 |
12 |
9 |
sd |
44 |
25 |
4 |
1 |
24 |
20 |
20 |
7 |
6 |
2 |
|
f(I) |
0.62 |
0.94 |
0.64 |
0.74 |
0.93 |
1.08 |
1.02 |
1,02 |
1.2 |
0.85 |
|
2.5 mg/pl. |
mean |
112 |
103 |
7 |
10 |
98 |
120 |
135 |
111 |
11 |
9 |
sd |
30 |
64 |
3 |
6 |
13 |
9 |
35 |
9 |
2 |
2 |
|
f(I) |
0.75 |
0.88 |
0.74 |
0.95 |
0.75 |
1.00 |
1.05 |
0.93 |
1.02 |
0.85 |
|
1.25 mg/pl. |
mean |
108 |
71 |
7 |
8 |
97 |
95 |
102 |
94 |
8 |
10 |
sd |
49 |
70 |
3 |
3 |
9 |
7 |
16 |
7 |
1 |
2 |
|
f(I) |
0.72 |
0.60 |
0.69 |
0.76 |
0.74 |
0.79 |
0.80 |
0.79 |
0.78 |
0.95 |
Applicant's summary and conclusion
- Conclusions:
- The substance was not mutagenic in five strains (TA97, TA98, TA100, TA102, TA1535) with and without metabolic activation.
- Executive summary:
The mutagenic potential of the substance was investigated in a bacterial reverse mutation assay according to OECD TG 471 under GLP. The substance was soluble and non-cytotoxic up to 5 mg/plate, i.e. the recommended maximum concentration. The substance was tested in five strains (TA97, TA98, TA100, TA102, TA1535) with and without metabolic activation (S9). In a first experiment, five concentrations (0.05; 0.15; 0.5; 1.5; 5.0 mg/plate) were tested for 48 hours in the plate incorporation method. In the second experiment the concentrations 1.25, 2.5 and 5.0 mg/plate were tested (48 h) in the pre-incubation method. The number of colonies were evaluated by eye. While the positive controls were clearly mutagenic, the substance did not increase the number of colonies. Therefore, the substance is considered to be not mutagenic.
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