Reaction products of sodium glucoheptonate with manganese sulfate and sodium hydroxide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

no guideline available

Principles of method if other than guideline:

Not applicable because publication is a review.

GLP compliance:

not specified

Specific details on test material used for the study:

Pure manganese or Cl2-salt is used as test material.

Analytical monitoring:

not specified

Details on sampling:

Not applicable because publication is a review.

Vehicle:

not specified

Details on test solutions:

Not applicable because publication is a review.

Test organisms (species):

other: please see "Details on test organisms"

Details on test organisms:

Oncorhynchus mykiss (Rainbow trout), Salmo trutta (Brown trout), Oncorhynchus kisutch (Coho salmon), Heteropneustes fossilis (Indian catfish), Channa punctatus (Indian freshwater murrel) and Colisa fasciatus (Giant gourami) were used by different researches as test organism.

Test type:

not specified

Water media type:

freshwater

Total exposure duration:

96 h

Hardness:

Not applicable because publication is a review.

Test temperature:

Not applicable because publication is a review.

pH:

7 - 8

Dissolved oxygen:

Not applicable because publication is a review.

Salinity:

Not applicable because publication is a review.

Conductivity:

Not applicable because publication is a review.

Nominal and measured concentrations:

Not applicable because publication is a review.

Details on test conditions:

Not applicable because publication is a review.

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Oncorhynchus mykiss (Rainbow trout)

Effect conc.:

4.8 mg/L

Conc. based on:

element

Duration:

96 h

Dose descriptor:

LC50

Remarks:

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

Effect conc.:

3.8 mg/L

Conc. based on:

element

Duration:

96 h

Dose descriptor:

LC50

Remarks:

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

Effect conc.:

49.9 mg/L

Conc. based on:

element

Duration:

96 h

Dose descriptor:

LC50

Remarks:

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

Effect conc.:

2.4 mg/L

Conc. based on:

element

Duration:

96 h

Dose descriptor:

LC50

Remarks:

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

Effect conc.:

17.4 mg/L

Conc. based on:

element

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Heteropneustes fossilis (Indian catfish)

Effect conc.:

3 350 mg/L

Conc. based on:

element

Remarks:

MnCl2 is used as test material.

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Channa punctatus (Indian freshwater murrel)

Effect conc.:

3 010 mg/L

Conc. based on:

element

Remarks:

MnCl2 is used as test material.

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Colisa fasciatus (Giant gourami)

Effect conc.:

2 850 mg/L

Conc. based on:

element

Remarks:

MnSO4 is used as test material.

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Colisa fasciatus (Giant gourami)

Effect conc.:

3 230 mg/L

Conc. based on:

element

Remarks:

MnSO4 is used as test material.

Details on results:

Not applicable because publication is a review.

Results with reference substance (positive control):

Not applicable because publication is a review.

Reported statistics and error estimates:

Not applicable because publication is a review.

Conclusions:

For fish, 96h LC50s range from 2.4 mg manganese/litre for coho salmon (Oncorhynchus kisutch) to 3350 mg manganese/litre for Indian catfish (Heteropneustes fossilis), with the lowest 96h LC50 values obtained under soft water conditions (25 mg calcium carbonate/litre).
Water hardness significantly affected manganese toxicity in tests with brown trout (Salmo trutta) and Coho salmon (Oncorhynchus kisutch) with toxicity decreasing with increasing hardness (2 - 250 mg CaCO3/L).

Executive summary:

For fish, 96 h LC50s range from 2.4 mg manganese/litre for coho salmon (Oncorhynchus kisutch) to 3350 mg manganese/litre for Indian catfish (Heteropneustes fossilis).

Water hardness significantly affected manganese toxicity in tests with brown trout (Salmo trutta) and Coho salmon (Oncorhynchus kisutch) with toxicity decreasing with increasing hardness (25 - 250 mg CaCO3/L).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Labeo rohita is exposed to various pure chloride compounds of metals (amongs other manganese(II)-chloride) at various concentrations for a period of 96 hours. Both for LC50 and lethal acute toxicity trails, the concentrations tested for fish were started from zero with an increment of 0.05 mg/L and 5 mg/L (as total concentration) for low and high concentrations, respectively. The observations of fish mortality, temperature, pH, total hardness, dissolved oxygen, total ammonia, sodium, potassium and carbondioxide were made at 12-h intervals during 96-h determination of LC50 and lethal concentrations (100% mortality) for the fish.

GLP compliance:

no

Specific details on test material used for the study:

No further details are given.

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

Chemically pure MnCl2 is dissolved in deionized water for the preparation of desired stock solutions.

Test organisms (species):

other: Labeo rohita

Details on test organisms:

TEST ORGANISM
- Common name: Rohu Carp
- Source: Fish Seed Hatchery, Faisalabad
- Age at study initiation: juvenile
- Length at study initiation: not specified
- Weight at study initiation: not specified
- Method of breeding: not specified
- Maintenance of the brood fish: not specified

ACCLIMATION
- Acclimation period: two weeks
- Acclimation conditions: not specified
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not specified
- Health during acclimation: not specified

FEEDING DURING TEST
- Food type: not specified
- Amount: not specified
- Frequency: not specified

Test type:

static

Water media type:

other: dechlorinated tap water

Limit test:

no

Total exposure duration:

96 h

Hardness:

100 mg/L

Test temperature:

30 °C

pH:

7

Nominal and measured concentrations:

Both for LC50 and lethal acute toxicity trails, the concentrations tested for fish were started from zero with an increment of 0.05 mg/L and 5 mg/L (as total concentration) for low and high concentrations, respectively.

Duration:

96 h

Dose descriptor:

LC50

Remarks:

age group: 30-day old fish

Effect conc.:

64.13 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Remarks:

age group: 60-day old fish

Effect conc.:

71.15 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Remarks:

age group: 90-day old fish

Effect conc.:

73.7 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

age group: 30-day old fish

Effect conc.:

99.82 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

age group: 60-day old fish

Effect conc.:

110.54 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

age group: 90-day old fish

Effect conc.:

108.74 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Remarks:

mean value for all age groups

Effect conc.:

70.96 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Remarks:

mean value for all tested age groups

Effect conc.:

106.98 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

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 concentrations (±SE) of iron, zinc, lead, nickel and manganese for Labeo rohita

Metals	Age group of fish	Mean 96 hr LC50 (mg/L)	95% conficence interval (mg/L)		Mean lethal concentration (mg/L)
Iron	30-day	49.75±2.78c	42.96	- 54.69	83.45 ± 5.14 b
	60-day	53.18±2.74b	46.36	- 58.05	85.53 ± 5.37 b
	90-day	58.18±2.74a	51.36	- 63.05	90.53 ± 5.37 a
Zinc	30-day	26.23±1.35c	22.90	- 28.71	41.75±2.92b
	60-day	28.36±1.38b	25.02	- 30.91	43.81 ± 2.84 b
	90-day	31.37±1.70a	26.99	- 34.41	49.36 ± 3.37 a
Lead	30-day	22.11±1.66c	17.91	- 25.11	38.80 ± 3.19 c
	60-day	27.20±1.74b	22.90	- 30.36	45.24±3.26b
	90-day	34.20±1.80a	29.70	- 37.53	52.36 ± 3.56 a
Nickel	30-day	22.01 ±1.69c	18.07	- 25.20	39.14±3.05b
	60-day	26.35 ±2.20b	20.97	- 30.43	50.32±4.59a
	90-day	29.40 ±2.13a	24.15	- 33.24	51.47±3.88a
Manganese	30-day	64.13±3.39b	56.06	- 70.48	99.82±6.63b
	60-day	71.15±3.77a	62.04	- 78.08	110.54±7.04a
	90-day	73.70±3.64a	64.63	- 80.30	108.74±6.44a

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

similar at p< 0.05.

Table 2: Comparison of means

		Mean concentrations (mg/L ± SD) forLabeo rohita
Age groups	30-day		60-day		90-day
LC50 concentrations	37.03±17.99 c		41.54±19.50 b		45.40±18.64 a
Lethal concentrations	60.20±26.97 c		67.51±28.82 b		69.84±26.12 a
Metals	Iron	Zinc	Lead	Nickel	Manganese
LC50 concentrations	54.30±3.37b	28.54±2.13c	27.65±5.34d	25.19±3.18 e	70.95±4.93 a
Lethal concentrations	87.02± 1.41b	44.07±3.53d	46.01±5.79c	45.18±6.48cd	106.98±7.80a

Means with same letters in a single row are statistically similar at p< 0.05.

Validity criteria fulfilled:

not specified

Conclusions:

Among the three age groups, 90-days fish showed significantly higher tolerance than that of 60- and 30 -days fish. The mean 96h LD50 and the 96h LD100 over all three age groups are 70.95 ± 4.93 and 106.98 ± 7.80 respectively.

Executive summary:

LC50 (96 h) value of manganese was recorded as 64.13 ± 3.39 mg L-1 for 30-days fish (Table 1), while for 60- and 90-days fish, it was 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. However, for 30-, 60- and 90 -days age groups, lethal concentrations (LC100 (96h)) 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 fish showed significantly higher tolerance than that of 60- and 30 -days fish. The mean LD50 (96 h) and the LD100 (96 h) over all three age groups are 70.95 ± 4.93 and 106.98 ± 7.80, respectively.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, LC50 (96h) determined according to APHA, AWWA and WPCF US standard methods. The given data indicate that the study was well performed.

Qualifier:

according to guideline

Guideline:

other: US APHA, AWWA, WPCF

Deviations:

not specified

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Colisa fasciatus

Details on test organisms:

TEST ORGANISM
- Common name: gourami
- Strain:
- Source: fish were collected locally (Gorakhpur, India)
- Age at study initiation (mean and range, SD): adult
- Weight at study initiation (mean and range, SD): 5.62 +/- 0.34 g
- Food type: powdered dried shrimp
- Amount: ad libitum

ACCLIMATION
- Acclimation period: 10 d

QUARANTINE (wild caught)
- Duration: unknown
- Health/mortality: unknown

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

90 h

Remarks on exposure duration:

LC50 was determined for 96 h according US APHA, AWWA, WPCF

Post exposure observation period:

none

Hardness:

120 mg/L as CaCO3

Test temperature:

25+/-1°C

pH:

7.3

Dissolved oxygen:

6.4 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquarium
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 6
- No. of vessels per vehicle control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Conductivity: 574 µohm

OTHER TEST CONDITIONS
- Adjustment of pH: 7.3
- Photoperiod: natural photoperiod

EFFECT PARAMETERS MEASURED: mortality

TEST CONCENTRATIONS
- Test concentrations: 2500 mg/L

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2 850 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

LC50 (96h) in Colisa fasciatus was determined according to APHA, AWWA and WPCF US standard method. The reported 96h LD50 value is 2850 mg/L.

Executive summary:

In a 96-h acute toxicity study, gouramis (Colina fasciatus) were exposed to Manganese sulfate at nominal concentrations of 2500 mg/L, additionally to negative control, under static conditions. The 96 h LC50 was 2850 mg/L, determined according US APHA, AWWA and WPCF.

This toxicity study is classified as reliable with restrictions and satisfies the requirements under REACH to fulfill this endpoint.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, LC50 (96h) determined according to APHA US standard method. The given data indicate that the study was well performed.

Qualifier:

according to guideline

Guideline:

other: US APHA

Deviations:

not specified

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

no further data

Test organisms (species):

Colisa fasciatus

Details on test organisms:

TEST ORGANISM
- Common name: gourami
- Source: fish were obtained from the local Ramgarh lake (Gorakhpur, India)
- Age at study initiation (mean and range, SD): adult
- Length at study initiation (length definition, mean, range and SD): 5.93 +/- 0.28 cm
- Weight at study initiation (mean and range, SD): 5.74 +/- 0.28 g
- Feeding during test: none

ACCLIMATION
- Acclimation period: 15 d
- Type and amount of food: dried powdered shrimp
- Feeding frequency: 2-3 times/day
- Health during acclimation (any mortality observed): on healthy animals were used

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

none

Hardness:

165.33 +/- 6.17 mg/L as CaCO3

Test temperature:

24.33 +/- 1.69°C

pH:

7.59 +/- 0.06

Dissolved oxygen:

7.65 +/- 0.08 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Material, size, headspace, fill volume: 30 L fill volume
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): none
- No. of vessels per vehicle control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Conductivity: 258.33 +/- 18.87 µohm/cm

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Test concentrations: 10 different concentrations

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

4 910 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

MnSO4

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 values vary from 4779 - 5043 mg/l

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 540 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

MnSO4

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 values vary from 4345 - 4743 mg/l

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

3 440 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

MnSO4

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 values vary from 3244 - 3647 mg/l

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

3 230 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

MnSO4

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 values vary from 2948 - 3538 mg/l

Results with reference substance (positive control):

no data

Reported statistics and error estimates:

Static bioassays were computed at 24, 48, 72 and 96 h according to the method given by APHA. Ninety-five percent confidence limits of LC50 values were determined according to the method of Litchfield and Wilcoxon.

Validity criteria fulfilled:

not specified

Conclusions:

The given data indicate that the test was well performed and the results can be considered as reliable. The LC50 values are 4910, 4540, 3440 and 3230 mg/L after 24, 48, 72 and 96 h, respectively.

Executive summary:

In a 96-h acute toxicity study, gouramis (Colina fasciatus) were exposed to Manganese sulfate at nominal concentrations of at least 10 different concentrations, additionally to negative control, under static conditions. The LC50 (96 h) was 3230 mg/L.

This toxicity study is classified as reliable with restrictions and satisfies the requirements under REACH to fulfill this endpoint.

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No standard duration (7d), two non-standard species (Tench, brook trout), no raw data listed, translation from German report, results provided as 'average time to death'. However, the given information indicate that the tests were well performed.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Invertebrate species (common carp, tench, rainbow trout, brook trout) are exposed to the test substance at a range of concentrations for a period of 7 days. Death is recorded immediately when occuring or latest at the end of the exposure period. The results are given as "Durchschnittliche Letalitätszeit" (Average time to mortality).

GLP compliance:

no

Specific details on test material used for the study:

No further details are given.

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

The manganese salt was directly added to Munich tap water, concentrations were calculated as mg/l metal. Prior to salt addition, water was softened by neutralisation with the corresponding amount of acid, i.e. 17.4 ml HCl conc. per 40 L water.

Test organisms (species):

other: common carp, tench, rainbow trout, brook trout

Details on test organisms:

TEST ORGANISMS
- Common name: common carp, tench, rainbow trout, brook trout
- Names as cited in report (German): Karpfen, Schleien, Regenbogenforellen, Bachsaiblinge

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

7 d

Remarks on exposure duration:

Test report states "Average time to death" of all used animals, no LC50 values are given. Since OECD Guideline 203 (acute toxicity) requires a 96 h test duration, LC100 values are determined from average time to death greater or equal to 4 days.

Hardness:

14,8°dH

Test temperature:

14-16°C resp. 16-18°C

pH:

neutralized, exact value not given

Dissolved oxygen:

aerated solution, no exact value given

Salinity:

no data

Details on test conditions:

Test vessel holds 40 L, no further data given.

Duration:

96 h

Dose descriptor:

other: LC100, one-summer carp

Effect conc.:

>= 800 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

other: LC100, one-summer tench

Effect conc.:

1 800 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

other: LC100, one-summer rainbow trout

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

other: LC100, one-summer brook trout

Effect conc.:

>= 150 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

other: LC100, two-summer carp

Effect conc.:

2 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

1 wk

Dose descriptor:

other: LC100, two-summer tench

Effect conc.:

2 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

34 h

Dose descriptor:

other: LC100, two-summer rainbow trout

Effect conc.:

600 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Duration:

41 h

Dose descriptor:

other: LC100, two-summer brook trout

Effect conc.:

600 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Mn2+

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Tab. 1: Average time to death, one-summer carp, 5 animals

 

Mn-Conc., mg/L	Average time to death	Surviving animals
2000	24 h	-
1800	25 h	-
1000	2 d, 15 h	-
900	3 d, 6 h	-
800	4 d, 4 h	-
700	5 d, 3 h	-
650	6 d, 15 h	-
600	7 d	5

 

 

Tab. 2: Average time to death, one-summer tench, 5 animals

 

Mn-Conc., mg/L	Average time to death	Surviving animals
5000	25 h	-
2000	2 d	-
1800	4 d	-
1500	6 d, 18 h	-
1300	7 d (4 animals), 6 d, 17 h (1 animal)	4
1200	7 d	5

 

 

Tab. 3: Average time to death, one-summer rainbow trout, 3 animals

 

Mn-Conc., mg/L	Average time to death	Surviving animals
700	10 h	-
600	13 h	-
300	1 d, 20 h	-
150	3 d, 5 h	-
100	5 d	-
75	7 d	3

 

 

Tab. 4: Average time to death, one-summer brook trout, 3 animals

 

Mn-Conc., mg/L	Average time to death	Surviving animals
700	15 h	-
600	23 h	-
300	2 d, 18 h	-
150	4 d, 19 h	-
100	7 d	3

 

 

Tab. 5: Average time to death, comparison between one-summer and two-summer fish

 

Species	Mn-Conc., mg/L	Average time to death, one-summer fish	Average time to death, two-summer fish
Carp	2000	24 h	48 h
Tench	2000	48 h	168 h
Rainbow trout	600	13 h	34 h
Brook trout	600	23 h	41 h

 

 

Validity criteria fulfilled:

not specified

Conclusions:

The given concentrations regard the metal only. The LD100 values for manganese range from > 100 mg/L (one-summer rainbow trout) to 2000 mg/L (two-summer carp and two-summer tench). In general, the toxicity is higher for one-summer fish than for two-summer fish. Additionally, although there are some deficiencies in the test report, the determined endpoints can be considered as reliable.

Executive summary:

The LD100 values for manganese range from > 100 mg/L (one-summer rainbow trout) to 2000 mg/L (two-summer carp and two-summer tench). In general, the toxicity is higher for one-summer fish than for two-summer fish.

The exact LD100 values are as follows:

One-summer carp: > 800 mg/L (after 96h)

One-summer tench: 1800 mg/L (after 96h)

One-summer rainbow trout: > 100 mg/L (after 96h)

One-summer brook trout: > 150 mg/L (after 96h)

Two-summer carp: 2000 mg/L (after 48h)

Two-summer tench: 2000 mg/L (after 1 week)

Two-summer rainbow trout: 600 mg/L (after 34h)

Two-summer brook trout: 600 mg/L (after 41h)

.

Reference 6

Endpoint:

short-term toxicity to fish

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 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

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):

Oryzias latipes

Details on test organisms:

No details given.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No details provided.

Hardness:

No details provided.

Test temperature:

24 +/- 1°C

pH:

min: 7.1 - max : 7.6

Dissolved oxygen:

Dissolved oxygen concentrations were over 60% of the saturation value (8.25 mg/L at 24.0°C)

Salinity:

Not applicable.

Nominal and measured concentrations:

Measured concentrations of the test substance were within +/- 20% of the nominal concentrations.

Details on test conditions:

TEST SYSTEM
- No. of organisms per vessel: 5 (range finding test)
- Biomass loading rate: 10 fish/concentration (definitive test)

OTHER TEST CONDITIONS
- Photoperiod: fluorescent light; 16 hours light/8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): toxicological symptoms and deaths

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

Reference substance (positive control):

not required

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and toxicological symptoms

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and toxicological symptoms

Details on results:

No details provided.

Results with reference substance (positive control):

No data.

Reported statistics and error estimates:

None reported.

Sublethal observations / clinical signs:

Measured concentrations of the test substance were within +/- 20% of the nominal concentrations. Results were based on the nominal concentrations.

No toxicological symptoms nor any death were observed at 100 mg/L (limit test).

Validity criteria fulfilled:

yes

Remarks:

Validity criteria (e.g. mortality in the control, constant conditions, dissolved oxygen concentration, concentration of the test substance) were met.

Conclusions:

NOEC/LC0 (96 h) > 100 mg/L

Executive summary:

The acute toxicity of sodium gluconate (CAS 527-07-1) towards fish was determined according to OECD Guideline 203 in compliance with GLP. A range finding test (5 fish/vessel/concentration) was conducted before the definitive test. Based on the results of the range finding test, only two concentrations were tested in the definitive test: 0 and 100 mg/L (limit test). Oryzias latipes served as test organism.

10 fish/concentration were used for the definitive test. Neither toxicological symptoms nor any death were observed at 100 mg/L. Conclusively, the NOEC/LC0 (96 h) was set to > 100 mg/L based on the nominal concentration.

Description of key information

There is no data available for the target substance manganese glucoheptonate on acute toxicity towards fish. However, there is data available for the source substances sodium gluconate, manganese sulfate and manganese chloride. This data is used within a frame of a weight-of-evidence approach to assess the toxicity of manganese glucoheptonate.

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 this corresponds to a LC50 (96 h) of 37.34 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

37.34 mg/L

Additional information

sodium gluconate

The acute toxicity of the source substance sodium gluconate (CAS 527-07-1) towards fish was determined according to OECD Guideline 203 in compliance with GLP (OECD SIDS, 2004). A range finding test (5 fish/vessel/concentration) was conducted before the definitive test. Based on the results of the range finding test, only two concentrations were tested in the definitive test: 0 and 100 mg/L (limit test). Oryzias latipes served as test organism. 10 fish/concentration were used for the definitive test. Neither toxicological symptoms nor any death were observed at 100 mg/L. Conclusively, the NOEC/LC0 (96h) was set to >100 mg/L based on the nominal concentration.

manganese compounds

The lethal concentrations of manganese was determined for manganese compounds like MnSO4 and MnCl2 for a variety of fish species. The studied species found in literature are comprised of 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 target substance MnGHA.

 

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 LC50 (96 h) for manganese glucoheptonate are 217.78, 241.6 and 250.3 mg/L for 30, 60 and 90-day old fish, respectively. The mean LC50 (96 h) for all groups is 241.3 mg/L. The calculated LC100 (96 h) for manganese glucoheptonate are 339.0, 375.4, 369.3 mg/L for 30, 60 and 90-day old fish, respectively. The mean LC100 (96 h) for all groups is 363.3 mg/L.

This result indicates, that manganese and manganese glucoheptonate is more toxic to younger Labeo rohita fishes.

 

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, additionally to 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 a LC50 of 8065.7 mg/L for manganese glucoheptonate. 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 a LC50 of 9141.2 mg/L for manganese glucoheptonate. Other reported LC50 values are 4910 mg/L after 24h, 4540 mg/L after 48h and 3440 mg/L after 73h. Those reported values correspond to 13895.7, 12848.6, 9735.5 mg/L, respectively, for manganese glucoheptonate. 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 LD50 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 LD50 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) with toxicity decreasing with increasing hardness (25 - 250 mg CaCO3/L). All calculated LC50 values for manganese glucoheptonate are summarized within Table 1. In general, the reported LC50 (96 h) for manganese glucoheptonate range from 18.7 mg/L (coho salmon) to 26057.5 mg/L (indian catfish).

 

Schweiger (1956) determined LC100s of manganese for four different species: carp, tench, rainbow trout and brook trout, Also, the author tested one-summer and two-summer fish. However, the study time was not consistent for all species and for one and two summer fishes. The determined LC100 values for manganese range from > 100 mg/L (one-summer rainbow trout) to 2000 mg/L (two-summer carp and two-summer tench). In general, the toxicity is higher for one-summer fish than for two-summer fish. The corresponding LC100 values for manganese glucoheptonate range from >777.8 mg/L (one-summer rainbow trout) to 15556.7 mg/L (two-summer carp and two-summer tench). All LC100 value are summarized in Table 1.

 

Conclusion

None of the used test organisms except Oncorhynchus mykiss are standard test organisms for the endpoint 'short term toxicity to fish'. The regarded studies indicate that almost all of the LC50 values of MnGHA on various fish species are clearly above the cut-off value for classification of 1 mg/L. 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. Schweiger (1956) who tested carp, tench, rainbow trout and brook trout can to the same conclusion as Abdullah et al (2007): manganese is less toxic to two-summer fishes than one-summer fishes.

  

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 this corresponds to a LC50 (96 h) of 37.34 mg/L.

Table 1: Lethal concentrations (LC) derived from studies performed with various manganese compounds and converted to manganese glucoheptonate (MnGHA).

Species	Duration of exposure	Dose descriptor	Mn GHA (70%) mg/L	Impact	Reference
Colisa fasciatus	24 h	LC50	13895.72		Nath, 1987
Colisa fasciatus	48 h	LC50	12848.59		Nath, 1987
Colisa fasciatus	72 h	LC50	9735.49		Nath, 1987
Colisa fasciatus	96 h	LC50	9141.18		Nath, 1987
Colisa fasciatus	96 h	LC50	8065.74		Agrawal, 1980
Labeo rohita, 30-day old fish	96 h	LC50	217.78		Abdullah et al, 2007
Labeo rohita, 60-day old fish	96 h	LC50	241.62		Abdullah et al, 2007
Labeo rohita, 90-day old fish	96 h	LC50	250.28		Abdullah et al, 2007
Labeo rohita	96 h	mean LD50 for all age groups	240.97		Abdullah et al, 2007
Oncorhynchus mykiss	96 h	LC50	37.34		WHO, 2004
Salmo trutta	96 h	LC50	29.56	soft water (25 mg CaCO3/L)	WHO, 2004
Salmo trutta	96 h	LC50	388.14	hard water (250 mg CaCO3/L)	WHO, 2004
Oncorhynchus kisutch	96 h	LC50	18.67	soft water (25 mg CaCO3/L)	WHO, 2004
Oncorhynchus kisutch	96 h	LC50	135.34	hard water (250 mg CaCO3/L)	WHO, 2004
Heteropneustes fossilis	96 h	LC50	26057.49		WHO, 2004
Channa punctatus	96 h	LC50	23412.85		WHO, 2004
Colisa fasciatus	96 h	LC50	22168.31		WHO, 2004
Colisa fasciatus	96 h	LC50	25124.09		WHO, 2004
Labeo rohita, 30-day old fish	96 h	LC100	338.98		Abdullah et al, 2007
Labeo rohita, 60-day old fish	96 h	LC100	375.39		Abdullah et al, 2007
Labeo rohita, 90-day old fish	96 h	LC100	369.27		Abdullah et al, 2007
Labeo rohita	96 h	mean LD100 for all age groups	363.3		Abdullah et al, 2007
Carp (one summer)	96 h	LC100	6222.68		Schweiger, 1956
Tench (one summer)	96 h	LC100	14001.04		Schweiger, 1956
Rainbow trout (one summer)	96 h	LC100	777.84		Schweiger, 1956
Brook trout (one summer)	96 h	LC100	1166.75		Schweiger, 1956
Carp (two summer)	45 h	LC100	15556.71		Schweiger, 1956
Tench (two summer)	1 week	LC100	15556.71		Schweiger, 1956
Rainbow trout (two summer)	34 h	LC100	4667.01		Schweiger, 1956
Brook trout (two summer)	41 h	LC100	4667.01		Schweiger, 1956