Zinc EDDHA

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to Read Across Statement attached in Section 13

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: for Rainbow trout, Carp, Catfish and Bluegill

Details on results:

Symptoms for each particular species:
Rainbow trout: slight discolorations, hypersensitivity, retarded movements and hyperventilation (all test concentrations)
Carp: slight hypersensitivity (within 48 h), slight diminished sensitivity (after 72 h), slight retarded movements and hyperventilation (all test concentrations)
Catfish: slight hypersensitivity at a test concentration of 49 ppm (within 48 h), slight diminished sensitivity (at 100 ppm and after 72 h for 49ppm), slight retarded movements
Bluegill: slight hypersensitivity at a test concentration of 100 ppm, slight diminished sensitivity, retarded movements and decreased respiration rate (at all test concentrations)

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

No statistics and error estimates.

Validity criteria fulfilled:

not specified

Remarks:

Basic scientific principles were met.

Conclusions:

In this acute toxicity test with Rainbow trout, Carp, Catfish and Bluegill the 96 h LC50 was greater than 100 mg/L. These results are based on nominal concentrations. The test material is practically devoid of acute toxicity to Trout, Carp, Catfish and Bluegill when tested and evaluated according to the procedure of Bathe et al. The same result is expected for the organic constituents of target substance since it has the same composition as the source substance.

Executive summary:

The acute toxic effects of Fe(Na)EDDHA to Rainbow trout, Carp, Catfish and Bluegill were determined (Sachssee and Barthe, 1977). The fish were tested in glass tanks of 12 and 15 litre capacity. Testing was performed in reconstituted water prepared of deionised water. Various concentrations of Fe(Na)EDDHA were prepared by adding the test material dissolved in aqua dest. (stock solution). (solubility of active ingr. in water: well miscible) at the appropriate amount ensuring that the total volume in each vessel remained the same.

In this acute toxicity test with Rainbow trout, Carp, Catfish and Bluegill the 96 h LC50 was greater than 100 mg/L. These results are based on nominal concentrations. Fe(Na)EDDHA is practically devoid of acute toxicity to trout, carp, catfish and bluegill when tested and evaluated according to the procedure of Bathe et al.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to Read Across Statement attached in Section 13

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No toxic signs were observed during the entire exposure time.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

Since the study is designed as a limit test, no statistical analysis was performed.

Sublethal observations / clinical signs:

Cumulative mortality (number of dead animals):

Nominal concentration [mg/L]	Number of fish	1 hour	6 hours	24 hours	48 hours	72 hours	96 hours
0	7	0	0	0	0	0	0
120	7	0	0	0	0	0	0

Toxic signs:

Nominal concentration [mg/L]	Number of fish	1 hour	6 hours	24 hours	48 hours	72 hours	96 hours
0	10	n	n	n	n	n	n
120	10	n	n	n	n	n	n

Explanation of abbreviations

n = no toxic signs observed                   

The following effect concentrations (mg/L) were obtained based on nominal concentrations:

	Observation time (hours after start of exposure)
	1 hour	6 hours	24 hours	48 hours	72 hours	96 hours
LC0	>120	>120	>120	>120	>120	>120
LC50 (95% confidence limits)	> 120 -	> 120 -	> 120 -	> 120 -	> 120 -	> 120 -
LC100	> 120	> 120	> 120	> 120	> 120	> 120
NOEC	>120	>120	>120	>120	>120	>120

- insufficient data for calculation

Validity criteria fulfilled:

yes

Remarks:

All study results are consistent with all validity criteria of the applied guideline.

Conclusions:

The study is regarded as a valid guideline study with certificated GLP compliance. According to the reported LC50 value (> 120 mg/L) the test substance is not classified as toxic to fish. The same result is expected for the organic constituents of target substance since it has the same composition as the source substance.

Executive summary:

The acute toxicity effects of the test substance to zebrafish (Danio rerio) over a 96 hour static exposure period were determined according to the principles of OECD-Guideline 203 and EU Method C.1. The experiment was conducted as limit test with an analytically confirmed test concentration of 120 mg/L. Therefore, no statistical analysis was performed. Since neither mortality nor toxic signs were observed, the LC50(96h) value is greater than tested concentration of 120 mg/L based on nominal concentrations. Based on the mean of analytically determined concentration, a value of greater or equal to 122 mg/L is reported. Since the analytically determined concentrations of the test substance in the test solutions were within +/- 20% of the nominal concentrations, the effect concentration is expressed relative to the nominal concentration. The corresponding NOEC was therefore determined to be greater than or equal to 120 mg/L.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to Read Across Statement attached in Section 13

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

5.85 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

2.29 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

5.05 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to target substance

Basis for effect:

mortality (fish)

Details on results:

The estimated 96 h LC50 was 439 µg Zn/L. All sculpin exposed to dissolved 778 µg Zn/L (the highest concentration) died by the ninth day. Mortality at 379 µg Zn/L increased from 46% at 96 h to 85% at 13 d. No mortality was observed at an exposure of 50 mg Zn/L or in the controls. No additional mortality occurred after 13 d through the end of the 30-d test. The LC50 values declined with time to an ILL50 (median incipient lethal level concentrations - the LC50 values derived at the time mortality ceased) of 266 µg Zn/L at 13 d. Mortality at the no-observed-effect concentration of 172 µg Zn/L was statistically similar to the controls. The statistically significant no-observed-effect concentration and lowest-observed- effect concentration were 172 and 379 µg Zn/L, respectively.

Sublethal observations / clinical signs:

The target substance contains 7.5 % Zn ions at the highest. Therefore, the hazard value for Zn ion is converted to the target substance considering a Zn content of 7.5 % as worst-case value.

LC50 (Zn ion) = 0.439 mg/L

LC50 (target substance) = 0.439 mg/L / 0.075 = 5.85 mg/L

NOEC (Zn ion) = 0.172 mg/L

NOEC (target substance) = 0.172 mg/L / 0.075 = 2.29 mg/L

LOEC (Zn ion) = 0.379 mg/L

LOEC (target substance) = 0.379 mg/L / 0.075 = 5.05 mg/L

Conclusions:

The median 96 h lethal zinc concentration (LC50) was 439 µg Zn/L (hardness of 154 mg/L as CaCO3) for feral mottled sculpin (Cottus bairdi), decreasing to a median incipient lethal level of 266 µg Zn/L after 13 d. The statistically significant no observed effect concentration and lowest observed effect concentration were 172 and 379 µg Zn/L, respectively.
This result is also relevant for the target substance, which contains 7.5 % zinc ions. Accounting to the Zn content of 7.5 %, this corresponds to LC50 value of 5.85 mg/L for the target substance. The corresponding NOEC and LOEC values for the target substance (assuming a Zn content of 7.5 %) is calculated to be 2.29 mg/L and 5.05 mg/L, respectively.

Executive summary:

The toxicity of zinc to the mottled sculpin (Cottus bairdi), the second most sensitive fish species for which toxicity data are available, was tested. The median 96 h lethal zinc concentration (LC50) was 439 µg Zn/L (hardness of 154 mg/L as CaCO3) for feral mottled sculpin (Cottus bairdi), decreasing to a median incipient lethal level of 266 µg Zn/L after 13 d. The statistically significant no-observed effect concentration and lowest observed effect concentration were 172 and 379 µg Zn/L, respectively.

This result is also relevant for the target substance, which contains 7.5 % zinc ions. Accounting to the Zn content of 7.5 %, this corresponds to LC50 value of 5.85 mg/L for the target substance. The corresponding NOEC and LOEC values for the target substance (assuming a Zn content of 7.5 %) is calculated to be 2.29 mg/L and 5.05 mg/L, respectively.

Description of key information

Acute toxicity in fish was experimentally determined for Fe(Na)EDDHA in Danio rerio (OECD TG 203, GLP). An LC50 (96h) value of > 120 mg/L (BASF 2010e) was determined. Furthermore, an LC50 (96h) of > 100 mg/L using Rainbow trout, Carp, Catfish and Bluegill was reported for Fe(Na)EDDHA (Sachsee & Barthe 1977).

To address the toxicity of the zinc ion in the target substance the key value for chemical safety assessment for freshwater fish was obtained in a study with Cottus bairdi (Brinkmann 2005). The LC50 (96 h) was converted to the target substance taking into account the Zn content of 7.5 % leading to an LC50 (96 h) value of 5.85 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

5.85 mg/L

Additional information

Read-across - Zn ion

Brinkman et al., 2005

The fish species (Cottus bairdi) was exposed to five different zinc concentrations (measured: 778, 379, 172, 94, 50, and < 5 µg dissolved Zn/L) for 30 days. Thereby, the median 96 h lethal zinc concentration (LC50) was 439 µg Zn/L (hardness of 154 mg/L as CaCO3) for feral mottled sculpin (Cottus bairdi), decreasing to a median incipient lethal level of 266 µg Zn/L after 13 d. The statistically significant no-observed-effect concentration and lowest-observed- effect concentration were 172 and 379 µg Zn/L, respectively.

 

This result is also relevant for the target substance, which contains 7.5 % zinc ions. Accounting to the Zn content of 7.5 %, this corresponds to LC50 value of 5.85 mg/L for the target substance. The corresponding NOEC and LOEC values for the target substance (assuming a Zn content of 7.5 %) is calculated to be 2.29 mg/L and 5.05 mg/L, respectively.