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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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: OECD guideline study; GLP compliance; read-across
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
not specified
Remarks:
The study reviewed in this report was stated to be GLP-compliant.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No details on properties are given.
Analytical monitoring:
yes
Details on sampling:
No details given.
Vehicle:
not specified
Details on test solutions:
Dilution water source: OECD M4 medium.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: GSF Institute of Ecological Chemistry, Germany
- Age at study initiation (mean and range, SD): juveniles within 24 hours old
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
Not reported.
Hardness:
247 mg/L as CaCO3
Test temperature:
21 ±0.5°C
pH:
5.92 – 8.41
Dissolved oxygen:
84–99 %
Salinity:
Not applicable.
Nominal and measured concentrations:
Measured concentrations were 3.93, 7.14, 14.0, 24.2, 44.7 and 83.6 mg/L (Nominal concentrations at 3, 6, 12, 23, 45 and 90 mg/L).
Details on test conditions:
TEST SYSTEM
- No. of organisms per vessel: 10
- No. of replicates: 3 replicates per 10 organisms were used

OTHER TEST CONDITIONS
- Adjustment of pH: no (The pH of test solutions remained neutral due to the buffering action of M4 medium.)
- Photoperiod: 16/8 (light/dark)
- Light intensity: 620 – 630 Lux

TEST CONCENTRATIONS
- Test concentrations: 0 (control), 3, 6, 12, 23, 45, 90 mg/L (nominal concentrations)
Reference substance (positive control):
not required
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
19 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: EC50 value with 95 % confidence limit was 15 – 25 mg/L.
Details on results:
No details given.
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
EC50 value and 95 % confidence limit were calculated by Probit method (EPA/600/4-85/13, 1985).

Table 1. The results of cumulative immobilization data for Daphnia magna

Nominal concentrations (mg/L) Measured concentrations (mg/L) Number of organisms tested Cumulative number of organisms immobilized
24 hrs 48 hrs
Control Control 30 0 0
3 3.93 30 0 4
6 7.14 30 0 5
12 14.0 30 0 11
23 24.2 30 0 13
45 44.7 30 12 23
90 83.6 30 30 30

Table 2. pH of test condition

Nominal concentrations (mg/L) Measured Concentrations (mg/L) 0 hr 48 hrs
Control Control 8.41 7.93
3 3.93 7.78 7.98
6 7.14 7.50 7.98
12 14.0 7.09 7.93
23 24.2 6.68 7.79
45 90 44.7 83.6 6.24 5.92 7.30
Validity criteria fulfilled:
yes
Remarks:
no immobilisation in control group; Dissolved oxygen concentration 84–99 %
Conclusions:
EC50 (48 h) = 19 mg FeCl2/L
Executive summary:

The acute toxicity of the read-across substance Iron dichloride (CAS 7758-94-3) towards Daphnia magna was determined according to OECD Guideline 202 in compliance with GLP. The following test concentrations have been used: 0 (control), 3, 6, 12, 23, 45 and 90 mg/L (based on nominal concentrations). Measured concentrations were 3.93, 7.14, 14.0, 24.2, 44.7 and 83.6 mg/L (Method applied: ICP-AES). The test organisms (3 replicates/concentration, 10 daphnids/vessel) were exposed for 48 h to the test substance. The EC50 (48 h) value based on mobility was determined to be 19 mg/L. EC50 (48 h) with 95 % confidence limit was 15 – 25 mg/L. EC50 value and 95 % confidence limit were calculated by Probit method (EPA/600/4-85/13, 1985).

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: study conducted according to OECD guidelines; quality assurance and GLP certificates; read-across
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
not specified
Remarks:
The study reviewed in the report was stated to be GLP-compliant.
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) towards Daphnia magna was 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.

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: study conducted according to OECD guidelines; quality assurance and GLP certificates; read-across
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
not specified
Remarks:
Study was stated to be GLP-compliant in the review
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.

Description of key information

There is no data available for the target substance iron glucoheptonate (CAS 23351 -51 -1) on acute toxicity towards invertebrates. However, there is data available for the read-across substances sodium gluconate (CAS 527 -07 -01) and iron dichloride (CAS 7758-94-3). This data is used within a frame of a weight-of-evidence approach to assess the toxicity of iron glucoheptonate.

The EC50 (48 h) value of 19 mg/L reported in a study with iron dichloride on Daphnia magna (OECD SIDS, 2004) was converted to the target substance FeGHA. The outcome is a EC50 (48 h) of 59.26 mg/L. The EC50 (48 h) value reported for Sodium gluconate was > 1000 mg/L (OECD SIDS, 2004a).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
59.26 mg/L

Additional information

There is no data available for the target substance Iron glucoheptonate (CAS 23351-51-1) on acute toxicity towards invertebrates. However, there is data available for the read-across substances Sodium gluconate (CAS 527-07-01) and Iron dichloride (CAS 7758-94-3).

 

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, 2004a). 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.

AIn addition, a limit test with 1000 mg/L sodium gluconateon D. magna 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 (OECD SIDS 2004b).

 

The acute toxicity of the read-across substance Iron dichloride (CAS 7758-94-3) towards Daphnia magna was determined according to OECD Guideline 202 in compliance with GLP (OECD SIDS, 2004). The following test concentrations have been used: 0 (control), 3, 6, 12, 23, 45 and 90 mg/L (based on nominal concentrations). Measured concentrations were 3.93, 7.14, 14.0, 24.2, 44.7 and 83.6 mg/L (Method applied: ICP-AES). The test organisms (3 replicates/concentration, 10 daphnids/vessel) were exposed for 48 h to the test substance. The EC50 (48 h) value based on mobility was determined to be 19 mg/L. EC50 (48 h) with 95 % confidence limit was 15 – 25 mg/L. EC50 value and 95 % confidence limit were calculated by Probit method (EPA/600/4-85/13, 1985).

 

 

Derivation of (non)-effective/lethal concentrations for Iron glucoheptonate (CAS 23351-51-1)

There are studies available for two different read-across substances (Sodium gluconate; Iron dichloride). Since it is expected that toxicity of the target substance is rather triggered by the iron cation, data on a metal salt are considered for the Chemical Safety Assessment.

 

An EC50 (48 h) value of > 1000 mg/L was determined for the substance Sodium gluconate (OECD SIDS, 2004). By consideration of the molecular weights of the read-across substance Sodium gluconate (MW = 218.14 g/mol) and the target substance Iron glucoheptonate (MW = 354.8 g/mol; trihydrated form), the EC50 value for the read-across substance can be converted in order to account for the target substance.

1000 mg/L x 354.8 g/mol / 218.14 g/mol = 1626.5 mg/L

The calculated EC50 (48 h) value of 1626.5 mg/L for the target substance will be used for the Chemical Safety Assessment.

 

The EC50 (48 h) value for Iron dichloride was determined to be 19 mg/L (OECD SIDS, 2004). Since this value refers to the compound itself and not only to the metal ion, a conversion is necessary. By consideration of the molecular weights of Iron dichloride (126.751 g/mol) and Iron (55.85 g/mol), the LC50 value for Iron is calculated as follows.

19 mg/L x 55.85 g/mol / 126.751 g/mol = 8.36 mg Fe/L

The EC50 of target substance FeGHA was derived with regard to the molecular weight by the following equation

MW Fe in FeGHA = 55.84 g/mol

MW FeGHA = 300.8 g/mol

EC (FeGHA) in target = EC (Fe) in source / 55.84 x 300.8

EC (Fe) in source = 8.36 mg/L

EC (FeGHA) in target = 8.36 / 55.84 x 300.8 = 45.03 mg/L

Purity: 76 %

45.03 / 0.76 = 59.26 mg/L

The calculated LC50 (48 h) value of 59.26 mg/L for the target substance will be used for the Chemical Safety Assessment.