[D-gluco-heptonato-κO1,κO2,κO3,κO6,κO7]calcium(II) nitrate

Toxicity to aquatic algae and cyanobacteria

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The substance has only been tested at 100 and 1000 mg/L because this test has been made on the basis of an older test according to a German norm; The inhibition level was thus expectable and the test concentrations limited to 100 and 1000 mg/L; read-across.

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

yes

Remarks:

The substance has only been tested at 100 and 1000 mg/L.

GLP compliance:

not specified

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No details given.

Analytical monitoring:

yes

Details on sampling:

No details provided.

Vehicle:

not specified

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Sample preparation: stock solution in redistilled water.

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Details on test organisms:

TEST ORGANISM
- Strain: CHODAT (strain No 86.81 SAG)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

No details reported.

Hardness:

No details reported.

Test temperature:

Test 1: 22.7-24.8°C 
Test 2: 23.4-27.9°C

pH:

pH maximal difference between 0 and 72 hours: 0.3

Dissolved oxygen:

No details reported.

Salinity:

Not applicable.

Nominal and measured concentrations:

No details reported.

Details on test conditions:

TEST SYSTEM
- Test vessel: flasks
- Type (delete if not applicable): For test 2, the procedure has been modified by covering the test vessels with glass petri dishes to prevent contamination by micro-organisms.
- Initial cells density: 10 x 10E4 algae/mL
- No. of vessels per concentration (replicates):Test 1: 3 flasks with test item and 6 flasks without test item were prepared. Test 2: 3 flasks with 100 mg/L, 3 flasks with 1000 mg/L and 6 flasks without test item.
- No. of vessels per control (replicates): 6

OTHER TEST CONDITIONS
- Photoperiod: illuminated with 4 parallel set universal white fluorescent tubes of approximately 65 cm above the level of the tested media
- Light intensity and quality: 8900-9300 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: counting chamber

TEST CONCENTRATIONS
- Test concentrations: Test 1: 1000 mg/L (invalid); Test 2: 100 and 1000 mg/L

Reference substance (positive control):

not required

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

No details reported.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

No details reported.

Test 1 : 1000 mg/L
not valid -  a decrease of the test item concentration was observed and therefore the test could not meet the stability requirements.

Cell growth inhibition : 85%
Average specific growth rate inhibition: 55%
---------------------

Test 2 : 100 mg/L and 1000 mg/L
Cell growth inhibition : no inhibition at 100 mg/L; 70% inhibition at 1000 mg/L

Average specific growth rate inhibition: no inhibition at 100 mg/L

42% inhibition at 1000 mg/L
----------------------------------------

Cell concentration increase in controls: factor 65.9 after 72 h

Validity criteria fulfilled:

not specified

Remarks:

Details such as coefficient of variation (average specific growth rates) are not reported.

Conclusions:

As final results and based on growth rate, an EC50 (72 h) of > 100 mg/L and a NOEC (72 h) of 100 mg/L were derived.

Executive summary:

The toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards algae has been determined according to OECD Guideline 201 in compliance with GLP. Two tests have been performed. In the first test, 1000 mg/L of the test item have been tested. However, a decrease of the test item concentration was observed and therefore the test could not meet the stability requirements. Conclusively, a second test with 100 and 1000 mg/L test concentration was performed. Desmodesmus subspicatus CHODAT (strain No 86.81 SAG) was used as test organism. An initial cell density of 10 x 10E4 algae/mL was applied. For the second test, 3 flasks with 100 mg/L, 3 flasks with 1000 mg/L and 6 flasks without test item were used. The common OECD procedure has been modified by covering the test vessels with glass petri dishes to prevent contamination by micro-organisms. After 24, 48 and 72 hours, cell concentration was determined using a microscope with a counter chamber (8 fields counted). No cell growth inhibition at 100 mg/L was determined. At 1000 mg/L, 70% cell growth inhibition was observed. For the average specific growth rate, no inhibition at 100 mg/L but 42% inhibition at 1000 mg/L was determined. The cell concentrations in controls increased by a factor of 65.9 after 72 h. As final results and based on growth rate, an EC50 (72 h) of > 100 mg/L and a NOEC (72 h) of 100 mg/L were derived.

Reference 2

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientific standard method applied; read-across.

Qualifier:

according to guideline

Guideline:

other: Finnish standard SFS 5072 (1986, Toxicity test with pure culture of algae)

Deviations:

not specified

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No details given.

Analytical monitoring:

not specified

Details on sampling:

No details given.

Vehicle:

no

Details on test solutions:

Stock solutions (0.05 M) of Gluconic acid were prepared by dissolving it with water-HCl solution (19.8 mL water + 200 µl 37% HCl) to a final
volume of 20.0 mL. After complete dissolution of the chelating agent pH was adjusted to 7.2 with 5 M and 1 M NaOH.

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

No details given.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

No details given.

Hardness:

No details given.

Test temperature:

22 ± 1°C

pH:

No details given.

Dissolved oxygen:

No details given.

Salinity:

Not applicable.

Nominal and measured concentrations:

No details given.

Details on test conditions:

TEST SYSTEM
- Test vessel: Flasks

OTHER TEST CONDITIONS
- Light intensity and quality: 5000 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Determination of cell concentrations: The growth was estimated with in vivo fluorescence of chlorophyll (Labsystems, Fluoroskan Ascent).

TEST CONCENTRATIONS
- Test concentrations: 1000 mg/L was the highest concentration tested.

Reference substance (positive control):

no

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

76 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

No details given.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

No details given.

Validity criteria fulfilled:

not specified

Remarks:

Exact description of applied bioassay is lacking.

Conclusions:

EC50 (72 h) = 76 mg/L (based on growth rate)

Executive summary:

Acute toxicity of four relatively new chelating agents and their equimolar manganese and cadmium complexes was studied. The chelating agents studied were gluconic acid (GA), β-alaninediacetic acid (ADA), diethylenetriaminepentakismethylenephosphonic acid (DTPMP), and nitrilotriacetic acid (NTA).

The bioassay with R. subcapitata using gluconic acid (CAS 526-95-4) was performed according to a Finnish standard SFS 5072 (1986, Toxicity test with pure culture of algae). At the time of an inoculation, the alga was in its exponential growth phase. During the test, the flasks were shaken in every 24 h. The volume in all tests was 10 mL and illumination intensity was set to 5000 lx. Temperature was maintained at 22 ± 1°C throughout the 72-h

test. Two simultaneous experiments were performed for each test concentration and the highest concentration of chelating agents was

1000 mg/L. The growth was estimated with in vivo fluorescence of chlorophyll (Labsystems, Fluoroskan Ascent) and the results obtained

from the bioassay are expressed as 72-h EC50 values with 95% confidence interval. The EC50 (72 h) value for gluconic acid is reported as 76 mg/L.

R. subcapitata proved the most sensitive to these compounds compared to Daphnia magna and Photobacterium phosphoreum.

Reference 3

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study conducted according to OECD guidelines; quality assurance and GLP certificates; read-across.

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

no

GLP compliance:

not specified

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No details given.

Analytical monitoring:

yes

Details on sampling:

No details given.

Vehicle:

no

Details on test solutions:

No details given.

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

No details given.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

No details reported.

Hardness:

No details reported.

Test temperature:

23+/- 2°C

pH:

No details reported.

Dissolved oxygen:

No details reported.

Salinity:

not applicable

Nominal and measured concentrations:

Measured concentrations of the test substance in the test solutions at the beginning of exposure were +/-20 % of the nominal concentrations.

Details on test conditions:

TEST SYSTEM
- Biomass loading: 1 x 10 E04 cells/mL

OTHER TEST CONDITIONS
- Photoperiod: continuous (+/- 20% at the surface of the test solutions)
- Light intensity and quality: 4000 lux

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 0 (control), 100, 180, 320, 560, 1000 mg/L (nominal concentrations)
- Results used to determine the conditions for the definitive study: A range-finding test was conducted before the definitive test to enable the above-mentioned concentration range in the definitive test.

Reference substance (positive control):

not required

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

560 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

No details reported.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

No details reported.

Cell growth inhibition at 1000 mg/L = 25.4 %

Growth rate inhibition (24-48 h) at 1000 mg/L = 7.6%

Growth rate inhibition (24-72 h) at 1000 mg/L = 9.0 %

50% growth inhibition concentration by comparison of areas
under the growth curves:

EbC50 (O-72 h): > 1000 mg/L
NOECb (0-72 h): 560 mg/L
----------------------------------------------------
50% growth inhibition concentration by comparison of growth
rates:

ErC50 (24 -48 h): > 1000 mg/L 
ErC50 (24-72 h): > 1000 mg/L
NOECr (24-72h) : 560 mg/L
NOECr (24-48h) : 560 mg/L

Color of the test solutions were observed with naked eye and the cell shapes of algae were observed through the microscope.  The test solutions were green at 24 hours after the start of exposure. Afterwards, the color of the test solutions showed a tendency to get more greenish with the passage of time.

No unusual cell shapes of algae and no agglutination were observed at the end of exposure and the algae looked normal compared to the control.

Validity criteria fulfilled:

not specified

Remarks:

Increase of biomass in control unknown.

Conclusions:

EC50 (72 h) > 1000 mg/L (based on growth rate; nominal concentration)
NOEC (72 h) = 560 mg/L (based on growth rate; nominal concentration)

Executive summary:

The acute toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards algae was determined according to OECD Guideline 201 in compliance with GLP.

A range-finding test was conducted prior to the definitive test to enable the following concentrations in the definitive test: 0 (control), 100, 180, 320, 560, 1000 mg/L (nominal concentrations). Measured concentrations of the test substance in the test solutions at the beginning of exposure were +/-20 % of the nominal concentrations. As test organism, Pseudokirchnerella subcapitata has been used (Biomass loading: 1 x 10 E04 cells/mL).

As final results, the EC50 (72 h) was determined to be > 1000 mg/L while the NOEC (72 h) was set to 560 mg/L based on the growth rate (nominal concentration).

Description of key information

OECD SIDS, 2004_OECD 201_Desmodesmus subspicatus: ErC (72 h) > 100 mg/L and NOErC (72 h) = 100 mg/L [Sodium gluconate]

Key value for chemical safety assessment

EC50 for freshwater algae:

100 mg/L

EC10 or NOEC for freshwater algae:

100 mg/L

Additional information

There is no data available for the target substance Calcium glucoheptonate (CAS 1821694-25-0) on acute toxicity towards fish. However, there is data available for the read-across substances Sodium gluconate (CAS 527-07-01) and Gluconic acid (CAS 526-95-4).

 

Referring to the key study, the toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards algae has been determined according to OECD Guideline 201 in compliance with GLP (OECD SIDS, 2004). Two tests have been performed. In the first test, 1000 mg/L of the test item have been tested. However, a decrease of the test item concentration was observed and therefore the test could not meet the stability requirements. Conclusively, a second test with 100 and 1000 mg/L test concentration was performed. Desmodesmus subspicatus CHODAT (strain No 86.81 SAG) was used as test organism. An initial cell density of 10 x 10E4 algae/mL was applied. For the second test, 3 flasks with 100 mg/L, 3 flasks with 1000 mg/L and 6 flasks without test item were used. The common OECD procedure has been modified by covering the test vessels with glass petri dishes to prevent contamination by micro-organisms. After 24, 48 and 72 hours, cell concentration was determined using a microscope with a counter chamber (8 fields counted). No cell growth inhibition at 100 mg/L was determined. At 1000 mg/L, 70% cell growth inhibition was observed. For the average specific growth rate, no inhibition at 100 mg/L but 42% inhibition at 1000 mg/L was determined. The cell concentrations in controls increased by a factor of 65.9 after 72 h. As final results and based on growth rate, an EC50 (72 h) of > 100 mg/L and a NOEC (72 h) of 100 mg/L were derived.

As supporting information, the acute toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards algae was determined according to OECD Guideline 201 in compliance with GLP (OECD SIDS, 2004). A range-finding test was conducted prior to the definitive test to enable the following concentrations in the definitive test: 0 (control), 100, 180, 320, 560, 1000 mg/L (nominal concentrations). Measured concentrations of the test substance in the test solutions at the beginning of exposure were +/-20 % of the nominal concentrations. As test organism, Pseudokirchnerella subcapitata has been used (Biomass loading: 1 x 10 E04 cells/mL).As final results, the EC50 (72 h) was determined to be > 1000 mg/L while the NOEC (72 h) was set to 560 mg/L based on the growth rate (nominal concentration).

With regard to the second supporting study, acute toxicity of four relatively new chelating agents and their equimolar manganese and cadmium complexes was studied (Silanpää et al., 2003). The chelating agents studied were gluconic acid (GA),β-alaninediacetic acid (ADA), diethylenetriaminepentakismethylenephosphonic acid (DTPMP), and nitrilotriacetic acid (NTA).The bioassay with R. subcapitata using gluconic acid was performed according to a Finnish standard SFS 5072 (1986, Toxicity test with pure culture of algae). At the time of an inoculation, the alga was in its exponential growth phase. During the test, the flasks were shaken in every 24 h. The volume in all tests was 10 mL and illumination intensity was set to 5000 lx. Temperature was maintained at 22 ± 1°C throughout the 72-h test. Two simultaneous experiments were performed for each test concentration and the highest concentration of chelating agents was 1000 mg/L. The growth was estimated with in vivo fluorescence of chlorophyll (Labsystems, Fluoroskan Ascent) and the results obtained from the bioassay are expressed as 72-h EC50 values with 95% confidence interval. The EC50 (72 h) value for gluconic acid is reported as 76 mg/L. R. subcapitata proved the most sensitive to these compounds compared to Daphnia magna and Photobacterium phosphoreum.

Derivation of effective concentrations for Calcium glucoheptonate (CAS 1821694-25-0)

In the key study, an EC50 (72 h) of > 100 mg/L and a NOEC (72 h) of 100 were determined for the read-across substance Sodium gluconate.

Since Ca2+ is known as an essential nutrient for plants/algae and is also contained in natural surface waters, a very low toxicity potential is assumed.Effect concentrations for acute and chronic aquatic toxicity on calcium inorganic salts (chloride and sulfate) are much greater than 100 mg/L for the relevant trophic levels. Consecutively, additional data on the calcium ion are not included. Assuming that considerable amounts of Calcium glucoheptonate (> 100 mg/L) reach the aquatic compartment, the amount of calcium would be far below the acute and chronic hazard values established for calcium inorganic salts.Thus, no harmful effects are expected related to calcium ions originated from Calcium glucoheptonate at 100 mg/L. Since it is assumed that toxicity of the glucoheptonate ion is similar to the toxicity of gluconate ion, revisions of the NOEC (quantitative read-across) are not necessary for the target substance. Therefore, EC50 (72 h) of > 100 mg/L and NOEC (72 h) value of 100 mg/L are established for Calcium glucoheptonate.