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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
The model uses primarily fragment descriptors, specific to a group of structurally related chemicals from the training set, therefore estimations of the number of used descriptors may be difficult. In general, we estimate that the model uses an order of magnitude less descriptors than there are observations. It should be noted that due to MultiCASE's complex decision making scheme, overfitting is rare, compared to simpler linear models. The model validation showed an appropriate q2, concordance and applicability domail.
Guideline:
other: REACH Guidence on QSARs R.6., May/July 2008
Principles of method if other than guideline:
A fragment based statistical system is used.
Specific details on test material used for the study:
Data reported for the anhydrous salt.
SMILES: [Na]OC(=O)C(O)C(O)C(=O)OK
Test organisms (species):
Pimephales promelas
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 1 000 mg/L
Details on results:
Validity of model: 1. Defined endpoint: acute toxicity to fish (lethality).
2. Unambigous algorithm: Fragment based statistical system. Descriptors: (1) Fragment descriptors, [2]Distance descriptors, [3]Physicochemical descriptors, [4]Electronic descriptors, [5]Quantum mechanics
descriptors. Result: LC50=1000 mg/L.
3. Applicability domain: Applicability domain of MultiCASE models is expressed in terms of absence of fragments unknown to the system and stat stical significance of the known biophores and biophobes.
Descriptors may also be taken into account. Failure to comply with the model domain is not absolute but may be graded, depending on the number and nature of the involved fragments.
4. Statistical characteristics: N=569, Coefficient determination (q2) = 0.76
5. The potassium sodium tartrate falls within the applicability domain described above and, therefore, the predicted value can be considered reliable taking into account that the standard deviation error of
prediction is 0.51. The predicted value is not below or close to the classification limit of toxicity to aquatic environment.

CL50 value estimated using MultiCASE platform 2005.

Training set=569

Validation: LGO(10%) gave q2=0.76, concordance=98 -100%, applicability domain = 0.47

Conclusions:
The Lc50 estimated value (1000 mg/L) for Fathead Minnow using the MultiCASE model included in the DK EPA database shows the low accute toxicity of the potassium sodium tartrate. This estimation is
considered appropriate in a weight of evidence approach.
Executive summary:

The model uses primarily fragment descriptors, specific to a group of structurally related chemicals from the training set, therefore estimations of the number of used descriptors may be difficult. In general,

we estimate that the model uses an order of magnitude less descriptors than there are observations. It should be noted that due to MultiCASE's complex decision making scheme, overfitting is rare,

compared to simpler linear models. The model validation showed an appropriate q2, concordance and applicability domail. The estimated value LC50=1000 mg/L indicates a low toxicity of the potassium

sodium tartrate.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2001
Justification for type of information:
Endpoint-specific justification for readacross
Reason / purpose:
read-across source
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 95.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
calculated as anhydrous
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
ca. 47 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
calculated as anhydrous
Basis for effect:
other:
Remarks:
toxicological symptoms, abnomalities
Results with reference substance (positive control):
LC50(96 hr) for a reference substance (copper sulfate pentahydrate) was 0.707 mg/L.
Reported statistics and error estimates:
Statistical Method:
a) Data Analysis: During test period the test organisms were lived more than 50% in all concentrations, therefore the LC50 is more than the highest
concentration.
b) Method of Calculating Mean Measured Concentrations (i.e. arithmetic mean, geometric mean, etc.): Arithmetic mean
Validity criteria fulfilled:
yes
Conclusions:
The toxicity of disodium tartrate towards the fish Oryzias latipes is low, with no significant mortality or effect detected at the test concentrations (up to 100 mg/L expressed as anhydrate). An LC50 96h of >
95.4 mg/L can be established for the substance. Given that potassium sodium tartrate is a structurally very similar C4 dicarboxyllic acid salt this result is considered as relevant towards read-across.
Executive summary:

A flow-through test was performed with fish species Oryzias latipes according to OECD TG 203. The test was run with 5 test

concentrations between 6.25 and 100 mg/L (nomimal, expressed asanhydrous disodium succinate) and one control, at one replicate per

concentration and 10 organisms / replicate. Water temperature was kept at 24 ± 1 °C, with no aeration and a photoperiod of 16:8. Fish

were not fed throughout the exposure period. Analytical controls of the test substance and water quality parameter were performed at the

beginning and end of the test, all being considred acceptable. A positive control performed with copper sulphate pentahydrate yielded a

96h LC50 of 0.707 mg/L and was considered acceptable.

The test resulted in a 96 h LC0 of 47.0 mg/L, 96 h LC50 > 95.4 mg/L and 96 h LC100 > 95.4 mg/L. In this test, only one individual out of

twenty died at the highest concentration of 95.4 mg/L. Results expressed in terms of measured concentrations of anhydrous disodium

succinate. Given that potassium sodium tartrate is a structurally very similar C4 dicarboxyllic acid salt this result is considered as relevant

towards read-across.

Endpoint:
short-term toxicity to fish
Type of information:
other: The Official Bulletin of the Ministry of Environment, Japan
Adequacy of study:
weight of evidence
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Disodium succinate hexahydrate (CAS No.: 6106-21-4, Nacalai Tesque, Inc. (Japan). Mol. formula: C4H4Na2O4.6H2O. Mol wt: 270.14 g/mol
Lot. No.: MOT9476, Purity = 100.2%
Disodium succinate is stable as a hexahydrate and has been produced as disodium succinate
hexahydrate (CAS No.: 6106-21-4) in Japan.
The toxicity studie was conducted using disodium succinate hexahydrate as the test substance, because there should be no difference between
disodium suucinate and disodium succinate hexahydrate in terms of environmental behavior, aquatic toxicity, and mammalian toxicity.

DETAILS ON PROPERTIES OF TES SURROGATE OR ANALOGUE MATERIAL
Disodium succinate (anhydrous) has the following physical properties: boil.p and melt.p.: > 400 °C; so lubility in water:> 100 g/L; vapour preseere: < 0,00015 at 100 °C; log Kow: < 0.59 (estimated); pKas: (1)
4,21; (2) 5,64 (for succinic acid).
Analytical monitoring:
yes
Details on test solutions:
Test chemical was refrigerated. The stability of the chemical was confirmed by IR spectrum. The IR spectrum at the end of the test was same at the start of test.
Test organisms (species):
Oryzias latipes
Details on test organisms:
Test Organisms:
a) Supplier: Test organisms were obtained from Nakajima Yougyo-jo (Private Fish Farm, Japan), before one month and a half of a test.
b) Size (length and weight): 2.3 cm (2.2 - 2.4 cm) in length; 0.16 g (0.13 - 0.23 g) in weight
c) Age: Not described
d) Any pretreatment: Test organisms were acclimated for 28 days before testing. During acclimation, test fishes were fed with TETRAMINE
equivalent to 3% of weight per day. These test organisms were not fed for 24 hours before the test started.
The mortality of the test organisms for 7 days before testing was less than 5%.
LC50(96 hr) for a reference substance (copper sulfate pentahydrate) was 0.707 mg/L.
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
Total hardness (as CaCO3): = 61.0 mg/L
Test temperature:
Water Temperature: 24+/-1ºC
pH:
pH: = 7.4
Dissolved oxygen:
DO: 7.5 - 8.3 mg/L
Nominal and measured concentrations:
Nominal Concentrations: control, 6.25, 12.5, 25.0, 50.0 and 100 mg/L
Mean measured concentration: 0, 5.64, 11.6, 23.6, 47.0, 95.4 mg/L
Details on test conditions:
-Test Conditions:
a) Dilution Water Source: Dilution water was prepared from tap water (Kurume city, Japan). The tap water was dechlorinated and treated by
activated carbon. After that Residual Chlorine was removed from the water. Before using the dilution water, aeration was fully carried out.
b) Dilution Water Chemistry: pH: = 7.4
Total hardness (as CaCO3): = 61.0 mg/L
c) Exposure Vessel Type: 1.8 L test solution in a 3 L glass beaker
d) Nominal Concentrations: control, 6.25, 12.5, 25.0, 50.0 and 100 mg/L
e) Vehicle/Solvent and Concentrations: Any solvent was not used.
f) Stock Solutions Preparations and Stability: Test chemical was refrigerated. The stability of the chemical was confirmed by IR spectrum.
The IR spectrum at the end of the test was same at the start of test.
g) Number of Replicates: 1
h) Fish per Replicates: 10
i) Flow-Through Rate of Test Water: The flow through rate of test medium was 30mL/min.
j) Water Temperature: 24+/-1ºC
k) Light Condition: 16:8 hours, light-darkness cycle
l) Feeding: None
m) Aeration : Test solution was not aerated during the test period.
Water chemistry (pH and DO) and temperature in test: Water chemistry and temperature were measured for old and renewal solution with control
and each concentration at the start of test and every 24 hours.
pH: 7.6 - 7.8
DO: 7.5 - 8.3 mg/L
Water Temperature: 24.1 - 24.9ºC
Reference substance (positive control):
yes
Remarks:
(LC50(96 hr) for a reference substance (copper sulfate pentahydrate) was 0.707 mg/L.)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 95.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
calculated as anhydrous
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
ca. 47 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
calculated as anhydrous
Basis for effect:
other:
Remarks:
toxicological symptoms, abnomalities
Results with reference substance (positive control):
LC50(96 hr) for a reference substance (copper sulfate pentahydrate) was 0.707 mg/L.
Reported statistics and error estimates:
Statistical Method:
a) Data Analysis: During test period the test organisms were lived more than 50% in all concentrations, therefore the LC50 is more than the highest
concentration.
b) Method of Calculating Mean Measured Concentrations (i.e. arithmetic mean, geometric mean, etc.): Arithmetic mean
Validity criteria fulfilled:
yes
Conclusions:
The toxicity of disodium tartrate towards the fish Oryzias latipes is low, with no significant mortality or effect detected at the test concentrations (up to 100 mg/L expressed as anhydrate). An LC50 96h of >
95.4 mg/L can be established for the substance. Given that potassium sodium tartrate is a structurally very similar C4 dicarboxyllic acid salt this result is considered as relevant towards read-across.
Executive summary:

A flow-through test was performed with fish species Oryzias latipes according to OECD TG 203. The test was run with 5 test

concentrations between 6.25 and 100 mg/L (nomimal, expressed asanhydrous disodium succinate) and one control, at one replicate per

concentration and 10 organisms / replicate. Water temperature was kept at 24 ± 1 °C, with no aeration and a photoperiod of 16:8. Fish

were not fed throughout the exposure period. Analytical controls of the test substance and water quality parameter were performed at the

beginning and end of the test, all being considred acceptable. A positive control performed with copper sulphate pentahydrate yielded a

96h LC50 of 0.707 mg/L and was considered acceptable.

The test resulted in a 96 h LC0 of 47.0 mg/L, 96 h LC50 > 95.4 mg/L and 96 h LC100 > 95.4 mg/L. In this test, only one individual out of

twenty died at the highest concentration of 95.4 mg/L. Results expressed in terms of measured concentrations of anhydrous disodium

succinate. Given that potassium sodium tartrate is a structurally very similar C4 dicarboxyllic acid salt this result is considered as relevant

towards read-across.

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Included and assigned Klimish 2 in peer-reviewed U.S. High Production Volume (HPV) Chemical Challenge Program Robust Summaries for Carboxylic Food Acids and Salts Category report.
Qualifier:
according to
Guideline:
other: DIN 38412 part 15
Principles of method if other than guideline:
Similar to OECD TG 203
GLP compliance:
no
Analytical monitoring:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
245 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Remarks:
But assigned Klimish 2 in USEPA HPV Food acids SIDS report
Conclusions:
The reported LC50 48h for fumaric acid is of 245 mg/L. Fumaric acid is an insaturated dibasic carboxyllic acid struturaly very similar to tartaric acid. It is considered to be a relevant study to support the low aquatic toxicity of potassium sodium tartrate.
Executive summary:

The reported LC50 48h for fumaric acid is of 245 mg/L. Fumaric acid is an insaturated dibasic carboxyllic acid struturaly very similar to tartaric acid. It is considered to be a relevant study to support the low aquatic toxicity of potassium sodium tartrate.There is limited information regarding the study as it is extracted from IUCLID4 and from USEPA HPV SIDS report for fumaric acid.

Description of key information

The key study refers to a test that resulted in a 96 h LC0 of 47.0 mg/L, 96 h LC50 > 95.4 mg/L and 96 h LC100 > 95.4 mg/L. In this test, only one individual out of twenty died at the highest concentration of

95.4 mg/L. Results expressed in terms of measured concentrations of anhydrous disodium succinate. Supporting information from another study on the toxicity of fumaric acid on Brachydanio rerio (Zebra

fish) indicates an LC50 48h of 245 mg/L. The estimated Fathead minnow (96h) LC50 for potassium sodium tartrate (1000 mg/L) using the MultiCASE QSAR model supports the low acute toxicity.

Key value for chemical safety assessment

LC50 for freshwater fish:
1 000 mg/L

Additional information

A flow-through test was performed with fish species Oryzias latipes according to OECD TG 203. The test was run with 5 test concentrations between 6.25 and 100 mg/L (nomimal, expressed asanhydrous

disodium succinate) and one control, at one replicate per concentration and 10 organisms / replicate. Water temperature was kept at 24 ± 1 °C, with no ae ration and a photoperiod of 16:8. Fish were not fed

throughout the exposure period. Analytical controls of the test substance and water quality parameter were performed at the beginning and end of the test, all being considred acceptable. A positive control

performed with copper sulphate pentahydrate yielded a 96h LC50 of 0.707 mg/L and was considered acceptable.

The test resulted in a 96 h LC0 of 47.0 mg/L, 96 h LC50 > 95.4 mg/L and 96 h LC100 > 95.4 mg/L. In this test, only one individual out of twenty died at the highest concentration of 95.4 mg/L. Results

expressed in terms of measured concentrations of anhydrous disodium succinate. Given that potassium sodium tartrate is a structurally very similar C4 dicarboxyllic acid salt this result is considered as

relevant towards read-across.

Fumaric acid is an insaturated dibasic carboxyllic acid struturaly very similar to tartaric acid. The supporting LC50 48h result of 245 mg/L (Brachydanio rerio (Zebra fish)). It is considered to be a relevant

study to support the low aquatic toxicity of potassium sodium tartrate.There is limited information regarding the study as it is extracted from IUCLID4 and from USEPA HPV SIDS report for fumaric acid.

A validated QSAR model was used to predict the LC50 96h of the substance Potassium Sodium Tartrate upon fish, specifically, Fat Head Minnow, employing MultiCASE. The model uses primarily fragment

descriptors, specific to a group of structurally related chemicals from the training set, therefore estimations of the number of used descriptors may be difficult. In general, we estimate that the model uses an

order of magnitude less descriptors than there are observations. It should be noted that due to MultiCASE's complex decision making scheme, overfitting is rare, compared to simpler linear models. The

model validation showed an appropriate q2, concordance and applicability domail. The estimated value LC50=1000 mg/L indicates a low toxicity of the potassium sodium tartrate.