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EC number: 939-513-8 | CAS number: -
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The original study was considered reliability 1. Read-across to the registered substance is considered scientifically justified and is reliability 2.
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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- METI, MHLW and MAFF
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [[(2-hydroxyethyl)imino]bis(methylene)]bisphosphonic acid
- EC Number:
- 227-833-4
- EC Name:
- [[(2-hydroxyethyl)imino]bis(methylene)]bisphosphonic acid
- Cas Number:
- 5995-42-6
- Molecular formula:
- C4H13NO7P2 (Constituent 1, linear form) C4H11NO6P2 (Constituent 2, cyclic form)
- IUPAC Name:
- [[(2-hydroxyethyl)imino]bis(methylene)]bisphosphonic acid
- Test material form:
- other: solution
Constituent 1
Method
- Target gene:
- Histidine operon (Salmonella strains); tryptophan operon (E. coli)
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:
- Phenobarbitone/beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 50-5000 µg active acid/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: no information in study report
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 3 µg/plate TA 100, 5 µg/plate TA 1535, 2 µg/plate WP2uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 80 µg/plate TA 1537
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without metabolic activation
Migrated to IUCLID6: 2 µg/plate TA 98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 1 µg/plate TA 100, 2 µg/plate TA 1535 and TA 1537, 10 µg/plate E. coli WP2uvrA
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
Migrated to IUCLID6: 5 µg/plate TA 98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
SELECTION AGENT (mutation assays): histidine/tryptophan deficient agar
NUMBER OF REPLICATIONS: Plated in triplicate, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn
METABOLIC ACTIVATION: S9 mix included glucose-6-phosphate, NADP and NADPH as co-factors. 0.5 ml of 10% S9 solution was added to 0.1 ml test material, 0.1 ml of bacterial culture and 2 ml of top agar - final concentration approx 2% S9. - Evaluation criteria:
- A test material is considered positive if it produces a reproducible, dose-related and statistically significant increase in the revertant count of at least one strain of bacteria.
- Statistics:
- Dunnett's method of linear regression
Results and discussion
Test resultsopen allclose all
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No test-specific confounding factors were reported, and no precipitation or toxicity were observed.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Cytotoxicity assay, revertants per plate
+/- S9 |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA 100 |
68 |
67 |
82 |
76 |
75 |
71 |
67 |
80 |
65 |
56 |
60 |
+ |
89 |
89 |
106 |
103 |
96 |
120 |
80 |
129 |
87 |
87 |
86* |
|
- |
WP” uvrA |
20 |
24 |
22 |
15 |
20 |
16 |
20 |
22 |
17 |
28 |
23 |
+ |
24 |
21 |
30 |
37 |
30 |
30 |
21 |
13 |
41 |
28 |
39 |
* Sparse bacterial background lawn
Table 2 Experiment 1, plate incorporation, revertants per plate (mean of 3 plates)
Dose (µg/plate) |
TA 100 |
TA1535 |
E. coli WP2 uvrA |
TA 98 |
TA1537 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Negative control** |
112 |
- |
33 |
- |
17 |
- |
29 |
- |
12 |
- |
0* |
99 |
102 |
33 |
16 |
29 |
23 |
20 |
33 |
13 |
17 |
50 |
93 |
99 |
33 |
16 |
21 |
24 |
14 |
30 |
11 |
16 |
150 |
96 |
94 |
41 |
17 |
23 |
25 |
21 |
23 |
14 |
14 |
500 |
114 |
97 |
28 |
15 |
22 |
25 |
20 |
34 |
12 |
15 |
1500 |
109 |
99 |
32 |
14 |
21 |
28 |
18 |
33 |
12 |
15 |
5000 |
95 |
75 |
31 |
16 |
24 |
26 |
19 |
24 |
12 |
15 |
Positive control |
442 |
868 |
211 |
314 |
816 |
1002 |
166 |
27117 |
1177 |
466 |
* solvent control with water
** spontaneous reversion rate
Table 2 Experiment 2, plate incorporation, revertants per plate (mean of 3 plates)
Dose (µg/plate) |
TA 100 |
TA1535 |
E. coli WP2 uvrA |
TA 98 |
TA1537 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
|
Negative control** |
120 |
- |
27 |
- |
25 |
- |
25 |
- |
12 |
- |
0* |
108 |
123 |
31 |
14 |
27 |
34 |
24 |
39 |
12 |
14 |
50 |
122 |
124 |
29 |
11 |
19 |
28 |
22 |
35 |
13 |
17 |
150 |
127 |
124 |
32 |
21 |
27 |
28 |
22 |
38 |
17 |
15 |
500 |
117 |
120 |
36 |
17 |
31 |
35 |
25 |
39 |
12 |
19 |
1500 |
120 |
121 |
34 |
19 |
27 |
31 |
17 |
31 |
15 |
14 |
5000 |
113 |
109 |
33 |
22 |
28 |
34 |
22 |
45 |
16 |
17 |
Positive control |
363 |
1232 |
251 |
|
615 |
1146 |
138 |
247 |
982 |
330 |
* solvent control with water
** spontaneous reversion rate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
HEBMP-H has been tested for mutagenicity to bacteria in a reliable assay conducted according to OECD 471 and under GLP. No increase in the number of revertants per plate was found with and without activation in Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and E.col WP2 uvrA in either the initial or the repeat plate incorporation assay. Appropriate positive, negative (spontaneous reversion) and solvent controls were included and gave expected results. It is concluded that the test substance is negative for the induction of mutation in bacteria under the conditions of the test.
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