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EC number: 221-618-9 | CAS number: 3164-29-2
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative in S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 and E. coli WP2 uvrA with and without metabolic activation
RA from source substance potassium sodium tartarate (CAS 304 -59 -6)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- / 2-AA used as sole indicator of S9 mix efficacy; duplicate plating without scientific justification; only 1 plate for some positive controls; no result of 2-AA (+S9 mix) in 1 exp (TA 1537, TA 1538 and WP2 uvr A); AF-2 used as positive control of WP2 uvr A
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Principles of method if other than guideline:
- - Principle of test: similar to OECD 471 but with several differences:
2-AA was used as sole indicator of S9 mix efficacy; duplicate plating without scientific justification; only 1 plate for some positive controls; no result of 2-AA (+S9 mix) in 1 exp (TA 1537, TA 1538 and WP2 uvr A); AF-2 used as positive control of WP2 uvr A - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon, trp operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats, treated with Aroclor 1254 (500 mg/kg bw)
- Test concentrations with justification for top dose:
- Based on a range-finding study (performed in tester strain TA 100; doses applied: 0.3 - 10000 μg/plate), the following concentrations were used in the main experiments:
TA 1535 / TA 100:
1st exp.: 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation
2nd exp.: 0.3, 3.3, 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation
TA 1537 / TA 1538 / TA 98 / WP2 uvr A:
1st exp.: 0.3, 3.3, 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation
2nd exp.: 33.3, 100, 333.3, 1000, 3333.3 and 10000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: potassium phosphate buffer
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- potassium phosphate buffer (0.067 M, pH 7)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: AF-2 (2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide), 2AA (2-Aminoanthracene)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) (Range Finding Test, first and second experiment)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: not provided - Statistics:
- Mean values were calculated.
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1538
- 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
- Key result
- 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:
- RANGE-FINDING/SCREENING STUDIES: A range finding assay was performed in TA 100. No mutagenicity and toxicity were observed.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1538
- 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
- Key result
- 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
Referenceopen allclose all
Table 1: Summary of test results (Exp. 1, Plate Incorporation Method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates) |
|||||
Frameshift type |
Base-pair substitution type |
||||||
TA98 |
TA1537 |
TA1538 |
TA100 |
TA1535 |
WP2 uvrA |
||
– |
Solvent control (potassium phosphate buffer) |
24* |
16* |
13* |
204* |
41* |
50* |
0.3 |
22 |
13 |
15 |
- |
- |
49 |
|
3.3 |
23 |
15 |
13 |
- |
- |
51 |
|
33.3 |
21 |
18 |
19 |
204 |
49 |
47 |
|
100 |
24 |
12 |
10 |
198 |
43 |
41 |
|
333.3 |
22 |
14 |
25 |
201 |
38 |
45 |
|
1000 |
22 |
11 |
11 |
174 |
48 |
36 |
|
3333.3 |
28 |
19 |
14 |
205 |
47 |
48 |
|
10000 |
14 |
14 |
16 |
183 |
37 |
53 |
|
Positive controls (µg/plate) |
2-NF (5) |
9AA (50) |
2-NF (5) |
SA (0.5) |
SA (0.5) |
AF2 (0.1) |
|
Mean No. of colonies/plate |
359 |
185 |
692 |
411** |
264** |
103 |
|
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate |
39** |
nt |
nt |
181** |
37** |
72** |
|
+ |
Solvent control (potassium phosphate buffer) |
36* |
11* |
22* |
252* |
41* |
102* |
0.3 |
47 |
14 |
21 |
- |
- |
47 |
|
3.3 |
34 |
18 |
17 |
- |
- |
53 |
|
33.3 |
40 |
16 |
32 |
244 |
69 |
48 |
|
100 |
31 |
18 |
32 |
219 |
78 |
51 |
|
333.3 |
38 |
14 |
27 |
246 |
67 |
52 |
|
1000 |
45 |
12 |
25 |
259 |
59 |
59 |
|
3333.3 |
34 |
13 |
24 |
256 |
62 |
49 |
|
10000 |
35 |
19 |
34 |
239 |
52 |
54 |
|
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate |
965** |
nt |
nt |
360** |
119** |
166** |
2AA = 2-aminoanthracene
2-NF = 2-nitrofluorene
9AA = 9-aminoacridine
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
SA = sodium azide
* = 4 results
** = 1 result
Table 2: Summary of test results (Exp. 2, Plate Incorporation Method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates) |
|||||
Frameshift type |
Base-pair substitution type |
||||||
TA98 |
TA1537 |
TA1538 |
TA100 |
TA1535 |
WP2 uvrA |
||
– |
Solvent control (potassium phosphate buffer) |
15* |
5* |
11* |
77* |
15* |
33* |
0.3 |
- |
- |
- |
77 |
14 |
- |
|
3.3 |
- |
- |
- |
76 |
17 |
- |
|
33.3 |
21 |
5 |
14 |
78** |
14 |
35 |
|
100 |
20 |
4 |
9 |
70 |
11 |
36 |
|
333.3 |
16 |
5 |
18 |
77 |
14 |
41 |
|
1000 |
21 |
5 |
11 |
70 |
11 |
34 |
|
3333.3 |
17 |
3 |
15 |
82 |
16 |
36 |
|
10000 |
15 |
5 |
17 |
67 |
12 |
39 |
|
Positive controls (µg/plate) |
2-NF (5) |
9AA (50) |
2-NF (5) |
SA (0.5) |
SA (0.5) |
AF2 (0.1) |
|
Mean No. of colonies/plate |
359** |
154** |
591** |
417 |
300 |
1581 |
|
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate |
18** |
3** |
19** |
89** |
7** |
nt |
|
+ |
Solvent control (potassium phosphate buffer) |
27* |
7* |
21* |
85* |
5* |
40* |
0.3 |
- |
- |
- |
65 |
9 |
- |
|
3.3 |
- |
- |
- |
84 |
7 |
- |
|
33.3 |
44 |
9 |
26 |
75 |
7 |
44 |
|
100 |
36 |
9 |
25 |
66 |
6 |
58 |
|
333.3 |
27 |
8 |
25 |
84 |
6 |
43 |
|
1000 |
28 |
8 |
24 |
71 |
5 |
52 |
|
3333.3 |
29 |
5 |
25 |
72 |
6 |
49 |
|
10000 |
27 |
6 |
21 |
65 |
7 |
57 |
|
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate |
104** |
41** |
89** |
882** |
76** |
nt |
2AA = 2-aminoanthracene
2-NF = 2-nitrofluorene
9AA = 9-aminoacridine
AF-2 = 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
SA = sodium azide
* = 4 results
** = 1 result
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic toxicity
Justification for read-across
There are no data for genetic toxicity in bacteria are available for diammonium tartrate (CAS 3164 -29 -2). To fulfil the standard data requirements defined in Regulation (EC) No. 1907/2006, Annex VII, 8.4, read-across from an appropriate substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI.
According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.
For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).
As no reliable measured/experimental data are available on genetic toxicity in bacteria with diammonium tartrate (CAS 3164 -29 -2), read-across to reliable data on the analogue substance potassium sodium tartrate (CAS 304 -59 -6) was conducted.
A bacterial gene mutation assay with the test substance was performed, similar to OECD Guideline 471 (Simmon and Eckford, 1979). In this study the substance was not mutagenic in any of the six strains (TA 1535, TA 1537, TA 1538, TA 98, TA 100 and WP2 uvrA) tested with and without metabolic activation.
Justification for classification or non-classification
Based on the analogue read-across approach and on the available data, there is no indication that the substance induces genetic toxicity in bacteria. Nevertheless, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on chromosomal aberration and mutagenicity in mammalian cells/in vivo is available.
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