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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
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: study conducted according to OECD guidelines; quality assurance and GLP certificates; read-across.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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:
not specified
Details on test solutions:
No details given.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: National Institute for Environmental Studies, Japan
- Age and gender: female juvenile (less than 24 hours)
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
No details given.
Hardness:
No details given.
Test temperature:
20 +/- 1°C
pH:
No details given.
Dissolved oxygen:
≥ 60% of the saturation
Salinity:
Not applicable.
Nominal and measured concentrations:
Measured concentrations of the test substance in the test solution were within +/- 20% of the nominal concentration in all concentrations.
Details on test conditions:
TEST SYSTEM
- No. of vessels/concentration: 2 (range-finding test)
- Biomass loading rate: 10 daphnids/concentration (range-finding test)

OTHER TEST CONDITIONS
- Photoperiod: fluorescent light, 16 hours light (below 800 lux)/8 hours dark

TEST CONCENTRATIONS
- Range finding study
- Results used to determine the conditions for the definitive study: yes

TEST MEDIUM
- Dilution water (Elendt M4) recommended by OECD guidelines for testing of chemicals No. 211 was used.
Reference substance (positive control):
not required
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
not specified
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:
immobilised daphnids in the control not reported
Conclusions:
EC50/NOEC (48 h) > 1000 mg/L (based on nominal concentration)
Executive summary:

The acute toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards Daphnia magna has been determined according to OECD Guideline 202 in compliance with GLP. After the range-finding study (2 vessels/concentration, 10 daphnids/concentration), the definitive test was conducted with test concentrations of 0 (control) and 1000 mg/L (limit test). The measured concentrations of the test substance in the test solution were within +/- 20% of the nominal concentration in all concentrations (HPLC technique has been used).

The EC50/NOEC (48 h) value amounts to > 1000 mg/L based on the nominal test concentration.

Endpoint:
short-term toxicity to aquatic invertebrates
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:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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:
not specified
Details on test solutions:
A limit test with 1000 mg/L was conducted: a solution of 100.5 mg in 100 mL or 1005 mg/L was prepared and distributed to 4 beakers.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain and source: Daphnia magna Straus origin from a clone breeding of the German Federal Environmental Agency, department V 3.2. 
- Age at study initiation: 2-23 h; Before using, the new young Daphnia were held at 20°C for 2 hours to ensure that none of them was younger than 2 h.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
No details given.
Hardness:
No details given.
Test temperature:
Temperature in the incubator was stable at 20°C during the test period.
pH:
pH difference between beginning and end of test = 0.2 units.
Dissolved oxygen:
Oxygen concentration was 95% of the start concentration. 
Salinity:
Not applicable.
Nominal and measured concentrations:
The stability of the investigated concentration of sodium D-gluconate during testing was also examined via enzymatic analysis.  The test concentration did not decrease during the test period.
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- No. of organisms per vessel: 5

OTHER TEST CONDITIONS
- Light intensity: complete darkness for 48 hours

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- After 24 and 48 h, the swimming capability of the daphnia was observed.  An animal not swimming within 15 seconds after gently moving the beaker was considered immobile. After 48 h, the oxygen concentration and the pH was measured.

TEST CONCENTRATIONS
- Test concentrations: 0 (control) and 1000 mg/L
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
> 1 000 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
> 1 000 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No details given.
Results with reference substance (positive control):
Quality Assurance takes place in regular intervals using a concentration range of Potassium dichromate.  Last quality check was January 2001 and EC50 was between 1.16and 2.32 mg/L (required: 0.6-2.4 mg/L).
Reported statistics and error estimates:
No details given.

At 1000 mg/L, all daphnia kept their swimming capability.

Validity criteria fulfilled:
not specified
Remarks:
immobilised daphnids in the control not reported
Conclusions:
EC0 (48 h) > 1000 mg/L
Executive summary:

The acute toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towardsDaphnia magnawas determined according to OECD Guideline 202 in compliance with GLP. A limit test with 1000 mg/L was conducted. The test organisms (5 daphnids/vessel) were exposed for 48 h to the test substance. The EC50 (48 h) value based on mobility was determined to be > 1000 mg/L. Toxic effects were not observed.

Description of key information

OECD SIDS, 2004_OECD 202_Daphnia magna: EC50 (48 h) > 1000 mg/L [Sodium gluconate]

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
1 000 mg/L

Additional information

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

 

As key information, the acute toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards Daphnia magna has been determined according to OECD Guideline 202 in compliance with GLP (OECD SIDS, 2004). After the range-finding study (2 vessels/concentration, 10 daphnids/concentration), the definitive test was conducted with test concentrations of 0 (control) and 1000 mg/L (limit test). The measured concentrations of the test substance in the test solution were within +/- 20% of the nominal concentration in all concentrations (HPLC technique has been used). The EC50/NOEC (48 h) value amounts to > 1000 mg/L based on the nominal test concentration.

As supporting information, the acute toxicity of the read-across substance Sodium gluconate (CAS 527-07-1) towards Daphnia magna was determined according to OECD Guideline 202 in compliance with GLP (OECD SIDS, 2004). A limit test with 1000 mg/L was conducted. The test organisms (5 daphnids/vessel) were exposed for 48 h to the test substance. The EC50 (48 h) value based on mobility was determined to be > 1000 mg/L. Toxic effects were not observed.

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

An EC50 (48 h) value of > 1000 mg/L was determined for the substance Sodium gluconate (OECD SIDS, 2004). 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/NOEC (96h) value of > 1000 mg/L is established for Calcium glucoheptonate.