Registration Dossier
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EC number: 206-156-8 | CAS number: 304-59-6
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Negative resuls obtained on bacterial mutagenicity study performed on potassoum sodium tartrate (Ames test) with and without metabolic activation. Negative results obtained also in in vitro chromosomal
aberration test performed on chinese hamster lung fibroblasts, employing analogue substance potassium hydrogen tartrate, as part of a mutagenicity screening programme sponsored by the Japanese
Ministry of Health ands Welfare.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- No metabolic activation employed
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium, other: TA 92 and TA 94
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction prepared from livers of pretreated rats with PCB compund Kanechlor KC-400
- Test concentrations with justification for top dose:
- Reported 6 concentrations. Maximum concentration tested is 0.5 mg/plate.
- Vehicle / solvent:
- Diluted in a solution of 0.1 N sodium hydroxyde.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
- Remarks:
- Details nos providad in paper, althogh numerous positive substances are reported.
- Details on test system and experimental conditions:
Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample.
The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.- Evaluation criteria:
- The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).
- 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:
- not specified
- Species / strain:
- S. typhimurium, other: TA 92 and TA 94
- 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:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 0.5 mg/ml on Salmonella strains TA 1535, TA 1537, TA 98, TA 92, TA 94 and TA 100, with and without metabolic activation as part of a programme sponsored by the Japanese Ministry of Health and Welfare to test common food additives. Results obtained on all strains tested at the maximum concentrations tested were negative. - Executive summary:
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 0.5 mg/ml on Salmonella strains TA 1535, TA 1537, TA 98, TA 92, TA 94 and TA 100, with and without metabolic activation as part of a programme sponsored by the Japanese Ministry of Health and Welfare to test common food additives. Results obtained on all strains tested at the maximum concentrations tested were negative. These results are considered valid to support conclusions of the analogue reference substance Potassoim Sodium Tartrate.
- 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well performed, well described study, commissioned in 1979 by USFDA and performed by reputed laboratory. Raw data available and method essentially as described in EU test method B13/14. Lack of evidence of GLP is only reason for not asigning Klimisch 1.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Duplicate instead of triplicate plates. However tests were performed twice.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor-1254 stimulated rat-liver homogenate (S9 mix) according to Ames et al.
- Test concentrations with justification for top dose:
- A range-finding assay was performes on strain TA 100 at concentrations of 0.3 - 10.000 µg/plate.
Sunsequently two assays were performed using the following test concentrations: 0.3, 3.3, 33.3, 100.0, 333.3, 1000.0, 3333.3 and 10000 µg/plate. In the second assay only the 6 highest concentrations were used. - Vehicle / solvent:
- 0.067 Potassium Phosphate buffer is used as vehicle / solvent (ph 7.0).
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Details on test system and experimental conditions:
- Test performed according to test developed by B. Ames. Briefly, innoculum from stck cultures is grown overnight a 37°C in Oxoid nutrient broth. After stationary overnight growth cultures are shaken for 3 - 4 h for optimal exponential growth.The standard plata-incorporation method is employed and test substance and controls are plated, with and without metabolic activation. Plates are incubated for 48 h at 37 °C and revertants are counted and recorded. Metabolic activation mixture contains 10% S9 fraction.
- Evaluation criteria:
- Not recordad, as no positive response was found. Presumably the modified two-fold rule is employed as stated in source publications and reference test method.
- 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:
- Report states that in the second experiment performed abnormally high numver of revertabts were seen with strains TA 1535 and TA100 (in samples and negative controls). This was subsequently attributed to the presence of traces of ethylene oxide in the plates used.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Potassium sodium tartrate tested in the Ames test with and without metabolic activation on Salmonella strains TA 1535, TA 1537, TA98, TA 100 and E.coli strain WP2 did not reveal any significant increase in revertants attributable to the test concentrations tested, neither signs of toxicity (as seen by background lawn observation) up to a maximum concentration of 10 mg/plate. Thereby the sample is considered to be negative in the bacterial mutagenicity test performed. - Executive summary:
Potassium sodium tartrate tested in the Ames test with and without metabolic activation on Salmonella strains TA 1535, TA 1537, TA98, TA 100 and E.coli strain WP2 did not reveal any significant increase in revertants attributable to the test concentrations tested, neither signs of toxicity (as seen by background lawn observation) up to a maximum concentration of 10 mg/plate. Thereby the sample is considered to be negative in the bacterial mutagenicity test performed.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- No metabolic activation employed
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Established originaly from lung of newborn female at the Cancer Research Institute, Tokyo (1970). Maintained by 4-day passages in Minnimum Essential Medoum (MEM) of GIBCO. The modal chromosomal number is 25 and the doubling time was approximately 15h.
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Three concentrations were used, although the report only states maximum concentration employed which is 2 mg/ml. This concentration is stated to be that producing 50% growth inhibition, as determined in a prelimnary study.
- Vehicle / solvent:
- Test medium
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- The cells were exposed to each sample at three different doses for 24 and 48 hr. No metabolic activation systems were applied. The maximum dose of each sample was selected by a preliminary test in which the dose needed for 50% cell-growth inhibition was estimated using a cell densitometer (Monocellater, Olympus Co., Ltd).
Previous studies indicated that the osmotic pressure of the medium generally rose with sample concentrations of more than 10 raM, SO that the maximum dose for some samples was limited to around this level, at which cytotoxic effects were not necessarily observed.
Chromosome preparations were made as follows. Colcemid (final concn 0.2/~g/ml) was added to the culture 2 hr before cell harvesting. The cells were then trypsinized and suspended in a hypotonic KCI solution (0.075 M) for 13 min at room temperature. After centrifugation the cells were fixed with acetic acid-methanol (1:3, v/v) and spread on clean glass slides. After air-drying, the slides were stained with Giemsa solution (1.5%, at pH 6.8; E. Merck) for 12-15 min. A hundred well-spread metaphases were observed under the microscope (x 600 with a nocover objective lens). The incidence of polyploid cells as well as of cells with structural chromosomal aberrations such as chromatid or chromosome gaps, breaks, exchanges, ring formations, fragmentations and others, was recorded on each culture plate.
. - Evaluation criteria:
- The results were considered to be negative if the incidence was less than 4.9%, equivocal if it was between 5.0 and 9.9%, and positive if it was more than 10.0 %. Untreated cells and solvent-treated cells served as negative controls, in which the incidence of aberrations was usually less than 3.0%
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- 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:
- valid
- Positive controls validity:
- other: Reported as valid although not verifiable in report avaiable
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 2 mg/ml on a Chinse Hamster lung established cell line and tested without metabolic activation. Results obtained at maximum non severly toxic concentrations after 48 hours of exposure do not indicate any significant amounts of structural aberrations or polyploidy (1%). Thereby the results point to the tested substancxe as being negative for clastogenesis in this mammalian cell line. - Executive summary:
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 2 mg/ml on a Chinse Hamster lung established cell line and tested without metabolic activation. Results obtained at maximum non severly toxic concentrations after 48 hours of exposure do not indicate any significant amounts of structural aberrations or polyploidy (1%). Thereby the results point to the tested substancxe as being negative for clastogenesis in this mammalian cell line.
Referenceopen allclose all
TABLE 1. SALMONELLA TYPHIMURIUM STRAIN TA1535. FDA COMPOUND F76-019 (Potassium Sodium Tartrate) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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TABLE 2. SALMONELLA TYPHIMURIUM STRAIN TA1537. FDA COMPOUND F76-019 (Potassium Sodium Tartrate) | ||||||||
Compound | Metabolic | Micrograms of compound | Histidine revertants per plate | |||||
Activation | added per plate | Experiment 1 | Experiment 2 | |||||
28 February 1978 | 14 March 1978 | |||||||
Average | Average | |||||||
Negative control | − | 17 | 24 | 16 | 6 | 3 | 5 | |
− | 9 | 14 | 4 | 5 | ||||
+ | 12 | 5 | 11 | 11 | 3 | 7 | ||
+ | 15 | 13 | 10 | 4 | ||||
Positive controls | ||||||||
9-Aminoacridine | − | 50 | 150 | 219 | 185 | 154 | ||
2-Anthramine | − | 1 | NT | 3 | ||||
+ | 1 | NT | 41 | |||||
F76-019 | − | 0,3 | 12 | 13 | 13 | |||
− | 3,3 | 10 | 19 | 15 | ||||
− | 33,3 | 15 | 20 | 18 | 5 | 4 | 5 | |
− | 100 | 17 | 7 | 12 | 6 | 2 | 4 | |
− | 333,3 | 13 | 15 | 14 | 5 | 5 | 5 | |
− | 1000 | 9 | 12 | 11 | 1 | 8 | 5 | |
− | 3333,3 | 14 | 23 | 19 | 1 | 5 | 3 | |
− | 10000 | 18 | 9 | 14 | 5 | 4 | 5 | |
+ | 0,3 | 14 | 14 | 14 | ||||
+ | 3,3 | 16 | 19 | 18 | ||||
+ | 33,3 | 15 | 16 | 16 | 6 | 12 | 9 | |
+ | 100 | 18 | 18 | 18 | 8 | 9 | 9 | |
+ | 333,3 | 17 | 10 | 14 | 7 | 8 | 8 | |
+ | 1000 | 13 | 11 | 12 | 11 | 4 | 8 | |
+ | 3333,3 | 14 | 12 | 13 | 6 | 3 | 5 | |
+ | 10000 | 13 | 24 | 19 | 8 | 4 | 6 |
TABLE 3. SALMONELLA TYPHIMURIUM STRAIN TA1538. FDA COMPOUND F76-019 (Potassium Sodium Tartrate) | ||||||||
Compound | Metabolic | Micrograms of compound | Histidine revertants per plate | |||||
Activation | added per plate | Experiment 1 | Experiment 2 | |||||
28 February 1978 | 14 March 1978 | |||||||
Average | Average | |||||||
Negative control | − | 13 | 13 | 13 | 9 | 14 | 11 | |
− | 12 | 13 | 9 | 10 | ||||
+ | 21 | 16 | 22 | 24 | 19 | 21 | ||
+ | 28 | 23 | 18 | 21 | ||||
Positive controls | ||||||||
2-Nitrofluorene | − | 5 | 597 | 787 | 692 | 591 | ||
2-Anthramine | − | 1 | NT | 19 | ||||
+ | 1 | NT | 89 | |||||
F76-019 | − | 0,3 | 13 | 17 | 15 | |||
− | 3,3 | 14 | 11 | 13 | ||||
− | 33,3 | 21 | 17 | 19 | 20 | 8 | 14 | |
− | 100 | 5 | 14 | 10 | 14 | 4 | 9 | |
− | 333,3 | 29 | 21 | 25 | 19 | 17 | 18 | |
− | 1000 | 14 | 8 | 11 | 15 | 7 | 11 | |
− | 3333,3 | 18 | 10 | 14 | 14 | 16 | 15 | |
− | 10000 | 13 | 19 | 16 | 20 | 14 | 17 | |
+ | 0,3 | 9 | 32 | 21 | ||||
+ | 3,3 | 14 | 19 | 17 | ||||
+ | 33,3 | 26 | 37 | 32 | 29 | 23 | 26 | |
+ | 100 | 30 | 34 | 32 | 27 | 22 | 25 | |
+ | 333,3 | 31 | 23 | 27 | 28 | 21 | 25 | |
+ | 1000 | 29 | 20 | 25 | 25 | 22 | 24 | |
+ | 3333,3 | 21 | 27 | 24 | 25 | 25 | 25 | |
+ | 10000 | 44 | 24 | 34 | 27 | 15 | 21 |
TABLE 4. SALMONELLA TYPHIMURIUM STRAIN TA98. FDA COMPOUND F76-019 (Potassium Sodium Tartrate) | ||||||||
Compound | Metabolic | Micrograms of compound | Histidine revertants per plate | |||||
Activation | added per plate | Experiment 1 | Experiment 2 | |||||
28 February 1978 | 14 March 1978 | |||||||
Average | Average | |||||||
Negative control | − | 28 | 21 | 24 | 19 | 18 | 15 | |
− | 20 | 27 | 11 | 12 | ||||
+ | 37 | 38 | 36 | 18 | 37 | 27 | ||
+ | 41 | 29 | 27 | 27 | ||||
Positive controls | ||||||||
2-Nitrofluorene | − | 5 | 345 | 373 | 359 | 359 | ||
2-Anthramine | − | 2,5 | 39 | 18 | ||||
+ | 2,5 | 965 | 104 | |||||
F76-019 | − | 0,3 | 26 | 17 | 22 | |||
− | 3,3 | 25 | 21 | 23 | ||||
− | 33,3 | 23 | 19 | 21 | 31 | 11 | 21 | |
− | 100 | 25 | 22 | 24 | 19 | 21 | 20 | |
− | 333,3 | 26 | 18 | 22 | 15 | 17 | 16 | |
− | 1000 | 20 | 23 | 22 | 15 | 27 | 21 | |
− | 3333,3 | 22 | 33 | 28 | 19 | 14 | 17 | |
− | 10000 | 12 | 15 | 14 | 17 | 13 | 15 | |
+ | 0,3 | 51 | 42 | 47 | ||||
+ | 3,3 | 30 | 37 | 34 | ||||
+ | 33,3 | 32 | 48 | 40 | 39 | 48 | 44 | |
+ | 100 | 27 | 35 | 31 | 36 | 35 | 36 | |
+ | 333,3 | 37 | 38 | 38 | 18 | 36 | 27 | |
+ | 1000 | 42 | 47 | 45 | 18 | 37 | 28 | |
+ | 3333,3 | 38 | 30 | 34 | 21 | 36 | 29 | |
+ | 10000 | 32 | 37 | 35 | 29 | 24 | 27 |
TABLE 6. ESCHERICHIA COLI WP2. FDA COMPOUND F76-019 (Potassium Sodium Tartrate) | ||||||||
Compound | Metabolic | Micrograms of compound | Tryptophan Revertants per plate | |||||
Activation | added per plate | Experiment 1 | Experiment 2 | |||||
28 February 1978 | 14 March 1978 | |||||||
Average | Average | |||||||
Negative control | − | 65 | 45 | 50 | 33 | 36 | 33 | |
− | 60 | 31 | 31 | 30 | ||||
+ | 55 | 53 | 57 | 57 | 45 | 40 | ||
+ | 65 | 56 | 24 | 34 | ||||
Positive controls | ||||||||
AF2 | − | 0,1 | 104 | 102 | 103 | 1581 | ||
2-Anthramine | − | 10 | 72 | NT* | ||||
+ | 10 | 166 | ||||||
F76-019 | − | 0,3 | 43 | 54 | 49 | |||
− | 3,3 | 53 | 48 | 51 | ||||
− | 33,3 | 39 | 55 | 47 | 42 | 28 | 35 | |
− | 100 | 45 | 37 | 41 | 32 | 39 | 36 | |
− | 333,3 | 51 | 39 | 45 | 39 | 43 | 41 | |
− | 1000 | 42 | 30 | 36 | 39 | 29 | 34 | |
− | 3333,3 | 44 | 52 | 48 | 23 | 48 | 36 | |
− | 10000 | 57 | 48 | 53 | 29 | 49 | 39 | |
+ | 0,3 | 57 | 37 | 47 | ||||
+ | 3,3 | 52 | 53 | 53 | ||||
+ | 33,3 | 48 | 48 | 48 | 43 | 44 | 44 | |
+ | 100 | 53 | 48 | 51 | 50 | 66 | 58 | |
+ | 333,3 | 53 | 50 | 52 | 50 | 36 | 43 | |
+ | 1000 | 63 | 55 | 59 | 46 | 57 | 52 | |
+ | 3333,3 | 48 | 50 | 49 | 50 | 48 | 49 | |
+ | 10000 | 52 | 56 | 54 | 53 | 60 | 57 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Potassium sodium tartrate tested in the Ames test with and without metabolic activation on Salmonella strains TA 1535, TA 1537, TA98,
TA 100 and E.coli strain WP2 did not reveal any significant increase in revertants attributable to the test concentrations tested, neither
signs of toxicity (as seen by background lawn observation) up to a maximum concentration of 10 mg/plate. Thereby the sample is
considered to be negative in the bacterial mutagenicity test performed.
The analogue substance potassium bitartrate (potassium hydrogen tartrate) was tested up to a maximum concentration of 2 mg/ml on a
Chinse Hamster lung established cell line and tested without metabolic activation. Results obtained at maximum non severly toxic
concentrations after 48 hours of exposure do not indicate any significant amounts of structural aberrations or polyploidy (1%). Thereby
the results point to the tested substancxe as being negative for clastogenesis in this mammalian cell line.
In the same set of experiments, potassium bitartrate was tested up to a maximum concentration of 0.5 mg/ml on Salmonella strains TA
1535, TA 1537, TA 98, TA 92, TA 94 and TA 100, with and without metabolic activation as part of a programme sponsored by the
Japanese Ministry of Health and Welfare to test common food additives. Results obtained on all strains tested at the maximum
concentrations tested were negative. These results are considered valid to support conclusions of the analogue reference substance
Potassoim Sodium Tartrate.
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