OligoActiv EDDHA-Mn

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

Duration:

96 h

Dose descriptor:

LC50

Remarks:

age group: 30-day old fish

Effect conc.:

373.16 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Remarks:

age group: 60-day old fish

Effect conc.:

414 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Remarks:

age group: 90-day old fish

Effect conc.:

428.84 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

age group: 30-day old fish

Effect conc.:

580.83 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

age group: 60-day old fish

Effect conc.:

643.21 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

age group: 90-day old fish

Effect conc.:

632.73 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Remarks:

mean value for all age groups

Effect conc.:

412.9 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

mean value for all tested age groups

Effect conc.:

622.49 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: no mortality among control fish

Sublethal observations / clinical signs:

Table 1. Calculated 96 h LC50 and lethal concentration (±SE) of manganese forLabeo rohita

Metal	Age group of fish	Mean 96 hr LC50 (mg/L)	95% conficence interval (mg/L)		Mean lethal concentration (mg/L)
Manganese	30-day	64.13±3.39	56.06	- 70.48	99.82±6.63
	60-day	71.15±3.77	62.04	- 78.08	110.54±7.04
	90-day	73.70±3.64	64.63	- 80.30	108.74±6.44
	mean	70.95 ± 4.93			106.98 ± 7.80

Means with same letters in a single column/age group are statistically

similar at p< 0.05.

Validity criteria fulfilled:

not specified

Conclusions:

The calculated 96h LC50 (Labeo rohita) for the manganese moiety in the target substance are 373, 414 and 429 mg/L for 30, 60 and 90-day old fish, respectively. The mean 96h LD50 for all groups is 413 mg/L.
The calculated 96h LC100 (Labeo rohita) for the manganese moiety in the target substance are 580, 643, 633 mg/L for 30, 60 and 90-day old fish, respectively. The mean 96h LD100 for all groups is 622 mg/L

Executive summary:

The data on manganese chloride allows estimating a corresponding LC50 and LC100 values for the manganese moiety in the target substance. 

 

The calculated 96h LC50 (Labeo rohita) for the manganese moiety in the target substance are 373, 414 and 429 mg/L for 30, 60 and 90-day old fish, respectively. The mean 96h LD50 for all groups is 413 mg/L.

The calculated 96h LC100 (Labeo rohita) for the manganese moiety in the target substance are 580, 643, 633 mg/L for 30, 60 and 90-day old fish, respectively. The mean 96h LD100 for all groups is 622 mg/L.

Reference 4

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

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

13 815.89 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Calculation of the LC50 value for target substance:

MW of source substance MnSO4 = 151

MW of Mn = 54.9

concentration of Mn in target substance: 7.89 %

 

LC50 for manganese sulfate = 2850 mg/L

LC50 for manganese = 2850 mg/L * (54.9/151) = 2850 mg/L * 0.36 = 1036 mg/L

LC50 of target substance = 1036 mg/L/0.075 = 13815.89 mg/L.

 

Conclusions:

Based on calculated LC50 (96 h) of 13815.89 mg/L, no short-term toxicity can be attributed to manganese in the target substance.

Executive summary:

The data on manganese sulfate allows estimating a corresponding LC50 for the ecotoxicity of manganese in the target substance.

The 96h LC50 (Colisa fasciatus) for manganese sulfate is reported to be 2850 mg/L which corresponds to a LC50 of 13815.89 mg/L for the manganese moiety in the target substance.

 

Reference 5

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

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

15 658 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

converted to the target substance

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Calculation of the LC50 value for target substance:

MW of source substance MnSO4 = 151

MW of Mn = 54.9

concentration of Mn in target substance: 7.5 %

 

LC50 for manganese sulfate = 3230 mg/L

LC50 for manganese = 3230 mg/L * (54.9/151) = 3230 mg/L * 0.36 = 1174.35 mg/L

LC50 of target substance = 1174.35 mg/L/0.075 = 15658 mg/L.

 

Conclusions:

Based on calculated LD50 (96 h) of 15658 mg/L, no short-term toxicity can be attributed to the manganese moiety in the target substance.

Executive summary:

The data on manganese sulfate allows estimating a corresponding LC50 for the manganese moiety in the target substance. The LC50 (Colisa fasciatus) for manganese sulfate is reported to be 3230 mg/L after 96h. This corresponds to 15658 mg/L, for the manganese moiety of the target substance.

 

Reference 6

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

Remarks:

Oncorhynchus mykiss (Rainbow trout)

Effect conc.:

64 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Salmo trutta (Brown trout), 25 mg CaCO3/L

Effect conc.:

50.67 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Salmo trutta (Brown trout), 250 mg CaCO3/L

Effect conc.:

665.33 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Oncorhynchus kisutch (Coho salmon), 25 mg CaCO3/L

Effect conc.:

32 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Oncorhynchus kisutch (Coho salmon), 250 mg CaCO3/L

Effect conc.:

232 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Heteropneustes fossilis (Indian catfish)

Effect conc.:

44 666.67 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Channa punctatus (Indian freshwater murrel)

Effect conc.:

40 133.33 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Colisa fasciatus (Giant gourami)

Effect conc.:

38 000 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Colisa fasciatus (Giant gourami)

Effect conc.:

43 066.67 mg/L

Conc. based on:

element

Remarks:

converted to target substance

Sublethal observations / clinical signs:

Calculation of the LC50 value for target substance:

concentration of Mn in target substance: 7.5 %

 

LC50 for manganese = 4.8 mg/L

LC50 of target substance = 4.8 mg/L/0.075 = 64.0 mg/L

LC50 for manganese = 3.8 mg/L

LC50 of target substance = 3.8 mg/L/0.075 = 50.67 mg/L

LC50 for manganese = 49.9 mg/L

LC50 of target substance = 49.9 mg/L/0.075 = 665.33 mg/L

LC50 for manganese = 2.4 mg/L

LC50 of target substance = 2.4 mg/L/0.075 = 32.0 mg/L

LC50 for manganese = 17.4 mg/L

LC50 of target substance = 17.4 mg/L/0.075= 232.0 mg/L

LC50 for manganese = 3350 mg/L

LC50 of target substance = 3350 mg/L/0.075 = 44666.67 mg/L

LC50 for manganese = 3010 mg/L

LC50 of target substance = 3010 mg/L/0.075 = 40133.33 mg/L

LC50 for manganese = 2850 mg/L

LC50 of target substance = 2850 mg/L/0.075 = 38000.0 mg/L

LC50 for manganese = 3230 mg/L

LC50 of target substance = 3230 mg/L/0.075 = 43066.67 mg/L

 

Conclusions:

The LC50 (96h) for manganese calculated for the manganese moiety in the target substance range from 32 mg/L (coho salmon) to 44667 mg/L (indian catfish). The key value is set to the lowest LC50 tested in a recommended species (Oncorhynchus mykiss). Converted to the target substance it is 64 mg/L.

Executive summary:

The data on manganese allows estimating a corresponding LC 50 (96 h) for the manganese moiety in the target substance. The LC50 (96h) for manganese calculated for the manganese moiety in the target substance range from 32 mg/L (coho salmon) to 44667 mg/L (indian catfish). The key value is set to the lowest LC50 tested in a recommended species (Oncorhynchus mykiss). Converted to the target substance it is 64 mg/L.

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 manganese ion in the target substance the key value for chemical safety assessment for freshwater fish was set to the lowest LC50 obtained in a test with a recommended species. The selected LC50 (96 h) value is 4.8 mg Mn/L. It was determined in Oncorhynchus mykiss (WHO 2007). Converted to the manganese moiety in the target substance taking into account the amount of manganese in the target substance, this corresponds to an LC50 (96 h) of 64 mg/L for the target substance. For the whole evaluation of the availbale data on manganese compounds please refer to 'Additional information'.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

64 mg/L

Additional information

Manganese compounds

The lethal concentrations of manganese was determined for manganese compounds including MnSO₄ and MnCl₂ for a variety of fish species. The studied species found in literature comprise Channa punctatus, Colisa fascinatus, Heteropneustes fossilis, Labeo rohita, Oncorhynchus kisutch, Oncorhynchus mykiss and Salmo trutto. The LC50 and LC100 found in literature were converted to the manganese moiety in the target substance.

 

Abdullah et al. (2007) recorded a LC50 (96 h) of 64.13 ± 3.39 mg/L for manganese on 30-days old fish (Labeo rohita), while the LC50 (96 h) for 60- and 90-day old fish, were 71.15 ± 3.77 and 73.70 ± 3.64 mg/L, respectively. Both 60- and 90-days age groups were statistically at par for their LC50 (96 h) and lethal manganese concentrations. For 30-, 60- and 90-days age groups, lethal concentrations (LC100 (96 h)) were recorded as 99.82 ± 6.63, 110.54 ± 7.04 and 108.74 ± 6.44 mg/L, respectively. Among the three age groups, 90-days Labeo rohita showed significantly higher tolerance than 60- and 30-days fish. The mean LC50 (96 h) and the LC100 (96 h) over all three age groups are 70.95 ± 4.93 and 106.98 ± 7.80 mg/L, respectively.

The calculated 96h LC50 (Labeo rohita) related to the manganese moiety in the target substance are 373, 414 and 429 mg/L for 30, 60 and 90-day old fish, respectively. The mean 96h LD50 for all groups is 413 mg/L.

The calculated 96h LC100 (Labeo rohita) related to the manganese moiety in the target substance are 580, 643, 633 mg/L for 30, 60 and 90-day old fish, respectively. The mean 96h LD100 for all groups is 622 mg/L.

 

Both, Agrawal (1980) and Nath (1987) tested the toxicity of manganese sulfate to gouramis (Colina fasciatus) in 96 hours toxicity studies. Agrawal (1980) used a nominal concentration of 2500 mg/L MnSO₄, in addition to a negative control, under static conditions. The LC50 (96 h) was 2850 mg/L, determined according US APHA, AWWA and WPCF. This reported LC50 for manganese sulfate corresponds to an LC50 of 13816 mg/L related to the manganese moiety of the target substance. Nath (1987) tested MnSO₄ at 10 different concentrations under static conditions and used negative controls, too. The derived LC50 (96 h) was 3230 mg/L, which corresponds to an LC50 of 15658 mg/L for the manganese moiety of the target substance. Since Agrawal (1980) and Nath (1987) tested under similar conditions and used the same test species, the results can be compared. It can be concluded, that both LC50 values which were determined after 96 hours are quite similar and in the same range of magnitude.

 

Within a report of the WHO, published in 2004, various LC50 values for different fish species are reported for elemental manganese. The LC50 (96 h) range from 2.4 mg manganese/L for coho salmon (Oncorhynchus kisutch) to 3350 mg manganese/L for indian catfish (Heteropneustes fossilis). Water hardness significantly affected manganese toxicity in tests with brown trout (Salmo trutta) and coho salmon (Oncorhynchus kisutch) where toxicity decreases with increasing hardness (25 - 250 mg CaCO₃/L).The LC50 (96h) for manganese calculated for the manganese moiety in the target substance range from 32 mg/L (coho salmon) to 44667 mg/L (indian catfish).

 

Conclusion

The available studies indicate that almost all of the LC50 values calculated for the manganese moiety of the target substance on various fish species are clearly above the cut-off value for classification. It is shown, that water hardness influences the toxicity of manganese to Salmo trutta and Oncorhynchus kisutch. In hard water (250 mg CaCO₃/L) the toxicity of manganese was significantly lower than in soft water (25 mg CaCO₃/L) (WHO, 2004).

Additionally, the toxic effect of manganese is depending on the age of fish. Abdullah et al. (2007) showed, that the LC50 and LC100 for Labeo rohita are lower for younger fish.

  

The key value for chemical safety assessment for freshwater fish was set to the lowest LC50 tested in a recommended species (according to OECD TG 203). The selected LC50 (96 h) value is 4.8 mg MnCl₂/L. It was determined in Oncorhynchus mykiss (WHO, 2004). Converted to the registered substance's Mn content this corresponds to an LC50 (96 h) of 64 mg/L.

Table 1: Lethal concentrations (LC) derived from studies performed with various manganese compounds and converted to the manganese moiety in the target substance.

Species	Duration of exposure	Dose descriptor	target substance (mg/L)	Impact	Reference
Colisa fasciatus	96 h	LC50	15658.89		Nath, 1987
Colisa fasciatus	96 h	LC50	13815.01		Agrawal, 1980
Labeo rohita, 30-day old fish	96 h	LC50	373.16		Abdullah et al, 2007
Labeo rohita, 60-day old fish	96 h	LC50	414		Abdullah et al, 2007
Labeo rohita, 90-day old fish	96 h	LC50	428.84		Abdullah et al, 2007
Labeo rohita	96 h	mean LC50 for all age groups	412.90		Abdullah et al, 2007
Oncorhynchus mykiss	96 h	LC50	64		WHO, 2004
Salmo trutta	96 h	LC50	50.67	soft water (25 mg CaCO3/L)	WHO, 2004
Salmo trutta	96 h	LC50	665.33	hard water (250 mg CaCO3/L)	WHO, 2004
Oncorhynchus kisutch	96 h	LC50	32	soft water (25 mg CaCO3/L)	WHO, 2004
Oncorhynchus kisutch	96 h	LC50	232	hard water (250 mg CaCO3/L)	WHO, 2004
Heteropneustes fossilis	96 h	LC50	44666.67		WHO, 2004
Channa punctatus	96 h	LC50	40133.33		WHO, 2004
Colisa fasciatus	96 h	LC50	38000.0		WHO, 2004
Colisa fasciatus	96 h	LC50	43066.67		WHO, 2004