Reaction mass of disodium carbonate and disodium sulfate and sodium chloride

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Peer reviewed publication - no raw data presented.

Justification for type of information:

See attached file

Qualifier:

equivalent or similar to guideline

Guideline:

other: Standard methods for the Examination of Water and Waste Water (APHA), Washington DC

GLP compliance:

no

Analytical monitoring:

no

Details on sampling:

no data

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

240 mg/l (without test material)

Test temperature:

11.5 to 14.5 °C - similar to the temperature of the pond from where the Daphnids were collected

pH:

7.2-7.8

Dissolved oxygen:

5.2 to 6.5 mg/l (begining of the study only)

Nominal and measured concentrations:

exposure concentrations not specified

Details on test conditions:

TEST SYSTEM
- Test vessel: 200 ml Beaker containing 100 ml of test solution
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 ml
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): not specified
- No. of vessels per vehicle control (replicates): not specified - no vehicle used.
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tubewell water filtered and aerated
- Total organic carbon: not specified
- Particulate matter: not specified
- Metals: not specified
- Pesticides: not specified
- Chlorine: 7 (5-10) mg/L
- Alkalinity: 400 (390 -415)
- Ca/mg ratio: 152 mg/l
- Conductivity: not specified
- Culture medium different from test medium: Water was taken from the pool where the Daphnia were collected from.
- Intervals of water quality measurement: begining of test. Begininig of test

OTHER TEST CONDITIONS
- Adjustment of pH: 7.2-7.8 not specified
- Photoperiod: not specified
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Lethality at 30 min 1,2,4,8,14, 24, 33, 48 h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: logarithmic
- Justification for using less concentrations than requested by guideline: n.a.
- Range finding study yes
- Test concentrations: not specified
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

no

Duration:

48

Dose descriptor:

EC50

Remarks:

complete immobilisation and no response to gentle agitation

Effect conc.:

874 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Effect concentration reported for Na only as 343.56 mg/L and adjusted to Na Cl by multiplying with (35.5+23)/23

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

874 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Reported statistics and error estimates:

EC50 and 95% cofidence intervals were calculated using the moving average-angle Method.

Conclusions:

While the study is not documented in significant detail, there is no reason to disregard this lowest value reported for acute toxicity to Daphnia magna

Executive summary:

In this study the toxicity of sodium chloride to Daphnia magna was tested together with a series of other metal salts to investigate correlation of the observed toxicity with relevant descriptors for the metals. The 48 hour toxicity of sodium chloride was reported in terms of the EC50 for immobilisation as 874 mg/l (as 343 mg/L Na+). No NOEC was reported and no raw data was presented that would allow conclusion on a NOEC.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Detailed description of testing procedure, no raw data, published in peer reviewed journal.

Justification for type of information:

See attached file

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

no

Analytical monitoring:

yes

Details on sampling:

no data

Test organisms (species):

Daphnia magna

Details on test organisms:

Laboratory clones

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Remarks on exposure duration:

In the same publication exposures of 21 days were performed.

Post exposure observation period:

n.a.

Hardness:

45.3 mg/L

Test temperature:

18 +/- 1 °C

pH:

7.4-8.2

Dissolved oxygen:

measured at saturation

Salinity:

n.a.

Nominal and measured concentrations:

not specified (5-12) test concentrations depending on test material.

Details on test conditions:

TEST SYSTEM
- Test vessel: no data
- Type: open
- Material, size, headspace, fill volume: no data
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):2
- No. of vessels per control (replicates): no data
- No. of vessels per vehicle control (replicates): no vehicle
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
Lake Superior water. Hardness and metal concentrations reported.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hr
- Light intensity: 115 ft-c

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: no data
- Justification for using less concentrations than requested by guideline: 5 or more concentrations used
- Range finding study: no data
- Test concentrations: not specified
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 136 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Reported as 1 640 000 µg/L of Na.

Details on results:

Two tests were performed. With and without feeding during exposure.
LC50 without feed: 4136 mg/L (reported as 1 630 000 µg/L of Na)
LC50 with feeding: 4590 mg/L (reported as 1 820 000 µg/L of Na).

Conclusions:

48 hr LC50 with Daphnia magna= 4136 mg/L

Executive summary:

Acute toxicity of NaCl to Daphnia magna was tested in a set-up similar to OECD guideline 202. The 48 hr LC50 with Daphnia magna is reported as 4136 mg/L. In the same article results from a study on reproduction and metabolism after 21 days of exposure of Daphnia magna are reported.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles. Method developed by Australian government authority. Taken from SIDS on sodium carbonate (2002) where a similar reliability was assigned.

Principles of method if other than guideline:

Method: method developed by NSW Environment Protection Authority (Warne & Julli, 1999)

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Ceriodaphnia sp.

Details on test organisms:

- Strain: Not reported.
- Source/supplier: Not reported.
- Breeding method: Cultures maintained in 2-L glass beakers and transferred to fresh water 3 times weekly.
- Age: Neonates less than 24 hr old.
- Feeding: After water renewal at a concentration of 25,000 cell/ml of each of the unicellular algae Pseudokirchneriellia subcapitata Printz and Ankistrodesmus sp.
- Pretreatment: Not reported.
- Feeding during test: Not fed.
- Control group: Yes.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

no

Details on test conditions:

DILUTION WATER
- Source: Dechlorinated Sydney mains water filtered, aged and adjusted to 500 microS/cm with seawater.
- Aeration: Not reported.
- Alkalinity: Not reported.
- Hardness: Not reported.
- Salinity: Not reported.
- TOC: Not reported.
- Ca/Mg ratio: Not reported.
- Na/K ratio: Not reported.
- TSS: Not reported.
- pH: Measured, not described.
- Oxygen content: Measured, not described.
- Conductance: Measured, not described.
- Holding water: Not reported.

TEST SYSTEM
- Concentrations: The bioassay consisted of five concentrations of sodium carbonate or soda ash in geometric series plus a control.
- Renewal of test solution: No.
- Exposure vessel type: 250 ml glass beakers which held 200 ml of the test solution or control solution.
- Number of replicates, individuals per replicate: For each concentration triplicates of five cladocera per beaker glass were used.
- Test temperature: 22-24°C
- Dissolved oxygen: Measured, not described.
- pH: Measured, not described.
- Adjustment of pH: Not reported.
- Intensity of irradiation: Below 1000 1x at the surface of the solution.
- Photoperiod: 16:8 h light:dark

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

200 - 227 mg/L

Basis for effect:

mobility

RESULTS: EXPOSED
- Nominal/measured concentrations: Values based on nominal
concentrations.
- Concentration / response curve: Not reported.
- Cumulative immobilisation: Not reported.
- Effect concentration vs. test substance solubility: Not
reported. 
- Other effects: Not reported. 
RESULTS CONTROL: Test was considered invalid when more than
10% of the control neonates were immobilized.
RESULTS: TEST WITH REFERENCE SUBSTANCE
- Concentrations: Not reported.
- Results: Not reported.

Conclusions:

Based on the EC50 = 200 - 227 mg/L, sodium carbonate is not considered as harmful to Ceriodaphnia.

Executive summary:

In a Study performed according to the method developed by NSW Environment Protection Authority (Warne &  Julli, 1999), the EC50 (48h) has been determined to be between 200 and 227 mg/L in deriodaphnia. Based on this results sodium carbonate is not harmful to invertebrates.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well conducted with standard guidelines and chemical analysis. No GLP no analytical certificates and no raw data.

Qualifier:

according to guideline

Guideline:

other: other guideline: EPA, 1994, Methods for measuring the toxicity and bioaccumulation of sediment-associated contaminants with freshwater invertebrates. EPA 600/R-94/024

Qualifier:

according to guideline

Guideline:

other: other guideline: EPA, 1993, Methods for measuring the acute toxicity of effluents and receiving waters to freshwater and marine organisms. EPA/600/4-90/027/F

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

No details given

Vehicle:

no

Details on test solutions:

Reformulated deionized water was prepared following the general procedures and ion formulations recommended in US EPA procedures.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: Cantest Ltd. Vancouver, Canada
- Age at study initiation: less than 24h

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

standard hardness: 106 mg CaCO3/l,
Several hardness levels were tested as well, namely 25, 50, 75 and 100 mg CaCO3/l.

Test temperature:

20 °C

pH:

7.5 - 8.1

Dissolved oxygen:

within 80% saturation

Nominal and measured concentrations:

No details given.
It is not known whether nominal or measured concentrations are use for the results. It is written that measured values would be used when the measured concentration would differ more than 10% from the nominal value, but no details are given in the publication whether or not this was the case.

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 250 ml Pyrex beakers with 200 ml test solution


EXPOSURE REGIME
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 3
- Feeding regime: No feeding


TEST MEDIUM / WATER PARAMETERS
- Type of water: Reformulated deionized water
- K+: 2.6 mg/l
- Na+: 32.8 mg/l
- Ca2+: 17.4, 27.2 or 37.0 mg/l
- Mg2+: 15.1, 9.2 or 3.2 mg/l
- SO4 2-: 101.5 mg/l
- Cl-: 2.4 mg/l
- HCO3 -: 87.2 mg/l


OTHER TEST CONDITIONS
- Photoperiod: 16h


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, every 24h

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

1 766 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 25 mg CaCO3/l, Ca:Mg molar ratio is 0.7

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

2 311 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 25 mg CaCO3/l, Ca:Mg molar ratio is 1.8

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

2 935 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 25 mg CaCO3/l, Ca:Mg molar ratio is 7.0

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

2 293 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 50 mg CaCO3/l

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 942 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 75 mg CaCO3/l

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 736 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 100 mg CaCO3/l, Ca:Mg molar ratio is 0.7

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

5 631 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 100 mg CaCO3/l, Ca:Mg molar ratio is 1.8

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

6 499 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Test medium with 100 mg CaCO3/l, Ca:Mg molar ratio is 7.0

Details on results:

Regression analysis indicated a highly significant relationship between water hardness and sulfate concentration. Toxicity decreased with increasing water hardness. The same is valid for calcium concentrations; toxicity decreased with increasing calcium concentration.

Reported statistics and error estimates:

LC50 values were calculated using the trimmed Spearman-Karber method.

The results in the publication are given as mg sulfate ion, these values were converted to mg sodium sulfate.

It is not known whether nominal or measured concentrations are use for the results. It is written that measured values would be used when the measured concentration would differ more than 10% from the nominal value, but no details are given in the publication whether or not this was the case.

Validity criteria fulfilled:

not specified

Conclusions:

Sodium sulfate is not toxic to D. magna, the lowest LC50 found in a water hardness of 25 mg CaCO3/l and Ca:Mg ration of 0.7 is 1766 mg/l. Under standard test conditions sodium sulfate is even less toxic, LC50 found there is 4736 mg/l. .
The test was found to be valid with restrictions because the study was well conducted with standard guidelines and chemical analysis. No GLP no analytical certificates and no raw data were documented. It is not known whether nominal or measured concentrations were used for the results. Sodium sulfate is stable in water over a period of 48h, therefore it is considered not to have an impact on the outcome and the conclusions of the test.

Executive summary:

The test was performed according to standard EPA methods. Daphnia magna was exposed to sodium sulfate for 48h in test medium with several different water hardness levels, namely 25, 50, 75 and 100 mg CaCO3/l.

For a water hardness of 25 and 100 mg CaCO3/l three different Ca:Mg molar ratios of 0.7, 1.8 and 7.0 were tested as well.

Sodium sulfate is not toxic to D. magna, the lowest LC50 found in water with the lowest hardness and a Ca:Mg ratio of 0.7 is 1766 mg/l. Under standard test conditions of 100 mg CaCO3/l and Ca:Mg ratio of 0.7 the LC50 is 4736 mg/l.

Reference 5

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

See Read-across justification attached.
Data on the reaction mass itself are not available. Therefore data on the three components are used. Based on the available studies, the EC50 for the three components are far higher than 100 mg/L. The lowest EC50 is for Sodium Carbonate. Therefore only the EC50 for Sodium Carbonate is reported and retained as a worst case.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

200 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Conclusions:

Not classified according to EU GHS Based on the data on the three components.

Description of key information

No experimental data are available that assess the short-term toxicity of the reaction mass of disodium carbonate and disodium sulphate and sodium chloride to aquatic invertebrates.

Nevertheless, the EC50 of the reaction mass was defined based on a worst case (i.e. the lowest EC50 of the three constituents was selected to reflect the EC50 of the reaction mass). Accordingly, the EC50 for aquatic invertebrates of the reaction mass of disodium carbonate and disodium sulphate and sodium chloride is 200 mg/L (based on the EC50 of sodium carbonate).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

200 mg/L

Additional information

No experimental data are available to assess the short-term toxicity to aquatic invertebrates of the reaction mass of disodium carbonate and disodium sulphate and sodium chloride. Nevertheless, reliable information is available for the Sodium chloride, Sodium Carbonate and sodium sulphate.The acute toxicity towards aquatic invertebrates of each constituents of the reaction mass (i.e. sodium chloride, sodium carbonate and sodium sulphate) is known and the EC50 of the reaction mass can thus be predicted. To this end, the key study assessing the acute toxicity of each compound was selected and was retained in a weight of evidence approach to assess the acute toxicity to aquatic invertebrates of the reaction mass.

Results from testing of acute toxicity to invertebrates of sodium chloride have been identified from a series of published studies. Preference has been given to studies which methodology follows or is similar to internationally accepted guidelines. With the exception of one study, the EC50 values for immobility are all > 3000 mg/L. The EC50 of sodium chloride for aquatic invertebrates was derived as the geometric mean of the two studies where animals were exposed for 48 hr: EC50 (Daphnia magna, 48 hr) = (874*4135)^(1/2) = 1900 mg/L. This value is well supported by other experimental data where animals were exposed for 24 hr.

For Sodium sulphate, several acute toxicity data are available. However, according to the OECD SIDS, only one reference describing a Daphnia magna test in 48 hours (Mount et al., 1997) was assigned validity 2. This test was not performed under GLP, but was performed according to EPA guideline, with determination of test substance (ion-chromatography), and details on test performance and statistics. Under the conditions of this study an 48-hour EC50 of 4.580 mg/L for Daphnia magna was obtained. According to the REACH registration dossier of sodium sulfate an other study (Davies and Hall 2007) is reported as Key study (and not available in the SIDS). This study was performed at several water hardness levels and 3 Ca:Mg ratios. Sodium sulfate is not toxic to Daphnia. magna, the lowest LC50 found in a water hardness of 25 mg CaCO3/l and Ca:Mg ratio of 0.7 is 1766 mg/l. Under standard test conditions sodium sulfate is even less toxic; the LC50 found is 4736 mg/L.

For Sodium carbonate, according to the OECD SIDS and the REACH registration dossier, the selected EC50 values to invertebrates for 48 hr exposure to sodium carbonate were 200 and 227 mg/L. This values was from a toxicity test with laundry detergent components and the freshwater cladoceran Ceriodaphnia cf. dubia published by Warne et al. (1999).

 

As a conclusion, the substance is a solution of inorganic salts in water. The constituents are inorganic substances which are naturally occurring in aquatic ecosystems. Sodium carbonate is the constituent with the highest toxicity for invertebrates and the EC50 for invertebrates was about 0.2 g/L. The EC50 of the reaction mass was defined based on a worst case (i.e. the lowest EC50 of the three constituents was selected to reflect the EC50 of the reaction mass). Accordingly, the EC50 for aquatic invertebrates of the reaction mass of disodium carbonate and disodium sulphate and sodium chloride is 200 mg/L.