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EC number: - | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Sep - 17 Nov 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - 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:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of tetra (potassium and sodium) (2R,3R)-2-hydroxy-3-(phosphonatooxy)succinate and potassium sodium (2S,3S)-2-hydroxy-3-(phosphonatooxy)succinate
- Physical state: white to yellowish powder of crystalline appearance
- Lot/batch No.: 010-2065
- Expiration date of the lot/batch: 16 Sep 2019
- Storage condition of test material: at temperatures < 40 °C, above fresh phosphorous pentoxide or in air tight sealed containers, reduce exposure to air to a minimum
- Other: very hygroscopic substance, pH = 9.45 (1% in solution)
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 3160 and 5000 μg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: highly purified water
- Justification for choice of solvent/vehicle: the test substance dissolved completely in water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- highly purified water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-aminoanthracene
- Remarks:
- -S9: sodium azide (10 µg/plate, TA100, TA1535); 2-nitrofluorene (10 µg/pl., TA98); 9-aminoacridine (100 µg/pl., TA1537); mitomycin C (10 µg/pl., TA102); +S9: benzo[a]pyrene (10 µg/pl., TA98, TA102, TA1537); 2-aminoanthracene (2 µg/pl., TA100, TA1535)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: experiment 1: in agar (plate incorporation); experiment 2: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3 replications in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- A test item is considered to show a positive response if:
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) at one or more concentrations compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537 and 1.5-fold of the solvent control for TA102 in both independent experiments.
- a concentration-related increase over the range tested in the number of the revertants per plate is observed. The Spearman's rank correlation coefficient may be applied.
In general the biological relevance of the results should be considered first by comparison of the results with the historical control data. If the test item shows positive results, these have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates. A test item for which the results do not meet the above mentioned criteria is considered as non-mutagenic in the Ames test. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed.
RANGE-FINDING/SCREENING STUDIES: a range-finding study (plate incorporation method) was performed with test strain TA 100 at concentrations of 15.8 - 250,000 μg/plate, with and without metabolic activation. No signs of cytotoxicity were observed up to and including the highest dose level, which was the maximum technically feasible concentration.
COMPARISON WITH HISTORICAL CONTROL DATA:
Yes, the negative and positive controls fell within the historical control data range.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No cytotoxicity was observed in any strains at any dose level with and without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Experiment 1
EXPERIMENT 1 (plate incorporation test) |
|||||
S9-mix |
Without
|
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
NC |
33.7 ± 1.2 |
170.0 ± 13.0 |
268.0 ± 14.2 |
21.3 ± 2.5 |
7.3 ± 0.6 |
31.6 |
29.3 ± 4.9 |
157.7 ± 4.9 |
272.7 ± 11.6 |
18.3 ± 3.1 |
5.3 ± 1.2 |
100 |
29.0 ± 1.0 |
145.3 ± 18.8 |
285.3 ± 10.4 |
22.7 ± 5.9 |
6.0 ± 0.0 |
316 |
33.7 ± 5.1 |
179.7 ± 11.9 |
276.7 ± 11.5 |
26.7 ± 2.1 |
6.0 ± 0.0 |
1000 |
31.7 ± 3.8 |
164.0 ± 19.1 |
280.7 ± 6.7 |
24.0 ± 2.6 |
5.0 ± 1.7 |
3160 |
30.7 ± 6.5 |
157.7 ± 14.0 |
246.7 ± 4.5 |
21.7 ± 1.2 |
5.7 ± 2.1 |
5000 |
21.0 ± 1.7 |
150.3 ± 5.5 |
252.0 ± 6.1 |
18.7 ± 7.2 |
5.7 ± 1.2 |
2-NF 10 µg/plate |
179.7 ± 6.8 |
- |
- |
- |
- |
SA 10 µg/plate |
- |
1080.7 ± 53.1 |
- |
161.0 ± 7.0 |
- |
MMC 10 µg/plate |
- |
- |
988.3 ± 13.1 |
- |
- |
9-AA 100 µg/plate |
- |
- |
- |
- |
72.3 ± 5.7 |
S9-mix |
With
|
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
NC |
39.7 ± 3.5 |
154.3 ± 8.3 |
301.0 ± 25.2 |
21.7 ± 2.5 |
7.7 ± 0.6 |
31.6 |
35.3 ± 11.2 |
171.3 ± 22.0 |
300.3 ± 4.2 |
19.0 ± 5.6 |
4.0 ± 1.0 |
100 |
29.7 ± 5.0 |
168.7 ± 18.5 |
281.0 ± 22.5 |
22.3 ± 6.0 |
6.7 ± 0.6 |
316 |
31.3 ± 1.5 |
146.7 ± 23.1 |
284.3 ± 34.5 |
19.0 ± 3.5 |
5.7 ± 1.5 |
1000 |
37.0 ± 1.7 |
171.3 ± 5.9 |
288.3 ± 29.9 |
19.7 ± 3.5 |
4.7 ± 0.6 |
3160 |
34.3 ± 3.2 |
165.3 ± 10.2 |
260.0 ± 2.6 |
16.3 ± 5.9 |
7.0 ± 2.0 |
5000 |
29.3 ± 6.5 |
166.3 ± 6.7 |
263.7 ± 14.9 |
22.3 ± 1.5 |
8.3 ± 1.2 |
2AA 2 µg/plate |
- |
1125.0 ± 38.6 |
- |
21.7 ± 2.5 |
- |
B[a]P 10 µg/plate |
183.3 ± 11.6 |
- |
1035.3 ± 76.8 |
- |
66.0 ± 4.4 |
NC = vehicle control, water 2-NF: 2-nitrofluorene SA: sodium azide 9AA: 9-aminocridine 2AA: 2-aminoanthracene B[a]P: benzo[a]pyrene MMC: mitomycin C (for details see method description) |
|||||
*, p<0.05 |
Table 2: Experiment 2
EXPERIMENT 2 (preincubation test) |
|||||
S9-mix |
Without
|
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
NC |
28.3 ± 2.1 |
124.0 ± 7.9 |
270.7 ± 26.3 |
19.0 ± 1.0 |
7.7 ± 1.2 |
31.6 |
25.0 ± 2.0 |
126.3 ± 6.8 |
288.7 ± 12.4 |
16.0 ± 1.7 |
6.3 ± 1.5 |
100 |
26.7 ± 7.2 |
115.7 ± 4.5 |
282.0 ± 9.8 |
16.0 ± 1.0 |
5.3 ± 1.2 |
316 |
24.7 ± 0.6 |
125.0 ± 13.2 |
287.0 ± 20.1 |
16.7 ± 3.8 |
6.7 ± 2.5 |
1000 |
25.0 ± 2.0 |
112.3 ± 2.5 |
263.0 ± 15.7 |
15.0 ± 3.0 |
5.7 ± 2.1 |
3160 |
30.3 ± 3.2 |
125.3 ± 9.1 |
268.0 ± 3.6 |
16.0 ± 2.6 |
6.0 ± 0.0 |
5000 |
27.3 ± 2.5 |
117.7 ± 2.5 |
253.7 ± 0.6 |
19.3 ± 2.5 |
5.3 ± 1.5 |
2-NF 10 µg/plate |
174.7 ± 1.5 |
- |
- |
- |
- |
SA 10 µg/plate |
- |
833.0 ± 3.6 |
- |
140.7 ± 0.6 |
- |
MMC 10 µg/plate |
- |
- |
1074.7 ± 115.0 |
- |
- |
9-AA 100 µg/plate |
- |
- |
- |
- |
45.0 ± 3.6 |
S9-mix |
With
|
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
NC |
28.3 ± 2.3 |
133.7 ± 17.0 |
286.3 ± 23.4 |
14.3 ± 0.6 |
8.7 ± 1.2 |
31.6 |
32.0 ± 3.5 |
124.0 ± 0.0 |
292.0 ± 3.0 |
16.0 ± 2.6 |
7.7 ± 4.2 |
100 |
29.3 ± 1.5 |
121.3 ± 9.3 |
273.3 ± 1.5 |
20.3 ± 1.5 |
5.0 ± 1.0 |
316 |
33.3 ± 6.0 |
142.3 ± 1.5 |
267.3 ± 14.4 |
17.7 ± 4.5 |
4.3 ± 1.2 |
1000 |
35.0 ± 1.0 |
152.7 ± 17.0 |
256.7 ± 2.9 |
21.0 ± 3.5 |
6.0 ± 2.6 |
3160 |
35.7 ± 4.5 |
147.3 ± 29.1 |
265.7 ± 11.6 |
17.7 ± 1.2 |
5.3 ± 1.2 |
5000 |
32.3 ± 2.5 |
121.7 ± 11.2 |
256.0 ± 1.0 |
17.7 ± 5.7 |
5.0 ± 2.6 |
2AA 2 µg/plate |
- |
827.3 ± 7.6 |
- |
134.7 ± 3.1 |
- |
B[a]P 10 µg/plate |
173.3 ± 0.6 |
- |
1004.0 ± 125.1 |
- |
53.3 ± 5.0 |
NC = vehicle control, water 2-NF: 2-nitrofluorene SA: sodium azide 9AA: 9-aminocridine 2AA: 2-aminoanthracene B[a]P: benzo[a]pyrene MMC: mitomycin C (for details see method description) |
|||||
*, p<0.05 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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