Pentapotassium bis(peroxymonosulphate) bis(sulphate)

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:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Not reported

Vehicle:

no

Details on test solutions:

Not reported

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM:
- Species/strain: Rainbow trout (Oncorhynchus mykiss)
- Source: RGW, Lincoln, UK
- Length at study initiation: 4.6 cm
- Weight at study initiation: 1.4 g
- Feeding during test: no

ACCLIMATION:
- Acclimation period: 14 days
- Type and amount of food: commercial fry crumb
- Feeding frequency: daily, until 24 h before test start

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not indicated

Hardness:

131 – 168 mg CaCO3/L

Test temperature:

15°C

pH:

6.9 – 7.1

Dissolved oxygen:

8.7 – 9.5 mg/L

Salinity:

Not indicated

Nominal and measured concentrations:

- Nominal concentrations: 0, 6.25, 12.5, 25, 50, 100 mg/L
- Mean measured concentrations: n.d., 6.51, 12.5, 27, 52, 101 mg/L
More details are given in "Any other information on materials and methods incl. attachements"

Details on test conditions:

TEST SYSTEM
- Test type: semi-static
- Renewal of test solution: daily
- Test vessel:
- Type: open
- Size: 20 L
- Aeration: yes, through narrow bore glass tube
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels/concentration: 1
- Volume/animal: 0.49 g fish/L water

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: laboratory tap water filt
- Alkalinity: 90 mg CaCO3/L
- Hardness: 131 – 168 mg CaCO3/L
- Conductivity: 370 µS/cm
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h photoperiod daily
- Light intensity: not reported

EFFECT PARAMETERS MEASURED :
Sublethal effects and mortality

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

27 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

27 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

53 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 43-68 mg/L

Duration:

96 h

Dose descriptor:

EC100

Effect conc.:

101 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Other biological observations: Reactions to exposure other than deaths were slight to severe loss of equilibrium and swimming at the surface at 52 mg/L and slight loss of equilibrium at 101 mg/L
- Mortality of control: 0%

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

EC50 values were calculated using logistic model (Ashton, 1972), 95% confidence limits estimated by likelihood ratio method (Williams, 1986).

Sublethal observations / clinical signs:

Mortality data

Test-Substance Concentration (nominal) [mg/L]	Mortality
	Number				Percentage
	24 h	48 h	72 h	96 h	24 h	48 h	72 h	96 h
0	0	0	0	0	0	0	0	0
6.25	0	0	0	0	0	0	0	0
12.5	0	0	0	0	0	0	0	0
25	0	0	0	0	0	0	0	0
50	0	0	2	3	0	0	28.6	42.9
100	0	7	7	7	0	100	100	100
Temperature [°C]	15	15	15	15
pH	6.9	7.1	7.1	6.9
Oxygen [mg/L]	9.5	9.4	8.7	9.3

 

 

Effect data

-	48 h [mg/l]1	95 % c.l.	96 h [mg/L]^1	95 % c.l.
LC0	52	n.a.	27	n.a.
LC50	72	57-93	53	43-68
LC100	101	n.a.	101	n.a.

¹effect data are based on measured concentrations

Validity criteria fulfilled:

yes

Conclusions:

The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). The LC50 for fish was determined to be 53 mg/L.

Executive summary:

Materials and methods:

An acute toxicity test in rainbow trout was performed according to OECD 203 without deviations. Fish were exposed for 96 h to 5 different concentrations in order to derive a LC50.

 

Results (96 hours):

NOEC:   27 mg/L     

LC0:      27 mg/L

LC50:     53 mg/L with a confidental interval of 43 - 68 mg/L

LC100:   101 mg/L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

yes

Remarks:

Please refer to 'Principles of method if other than guideline'

Principles of method if other than guideline:

Deviations to the guideline: The lowest three concentrations were not analysed for stability, homogeneity or accuracy of concentration due to the limitation of the analytical method. The procedures used to prepare the dosing preparations were ensured by accurate weighing of test substance and analysis of stock solutions.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 222, 444, 889, 1780, 3560 µg KMPS triple salt/L, corresponding to
100, 200, 400, 800, 1600 µg KHSO5/L

Vehicle:

no

Details on test solutions:

not indicated

Test organisms (species):

Cyprinodon variegatus

Details on test organisms:

TEST ORGANISM
- Common name: Sheephead minnow (Cyprinodon variegates)
- Source: in-house culture
- Length at study initiation (length definition, mean, range and SD): 20 – 30 mm,
- Weight at study initiation (mean and range, SD): 0.283 – 0.932 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: 3 days
- Type and amount of food: commercial fish food until 24 h before test start, the amount of food is not reported
- Feeding frequency: daily
- Acclimation conditions: in laboratory salt water (20 ‰)

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not indicated

Hardness:

not indicated

Test temperature:

22±2°C

pH:

7.7 – 8.2

Dissolved oxygen:

4.5 – 7.4 mg/L

Salinity:

20 ± 3 ‰

Nominal and measured concentrations:

Nominal concentrations: 222, 444, 889, 1780, 3560 µg KMPS triple salt/L, corresponding to
100, 200, 400, 800, 1600 µg KHSO5/L

Measured concentrations of test substance: the two highest solutions were analysed
0 h (Replicate A and B): 624 and 685, 1350 and1340 µg KHSO5/L ,
78 – 86% of nominal
Concentrations of stock solution ranged from 93 to 108% of nominal
96 h: below LOQ (LOQ = 700 µg/L)
More details are given in Table 1, which is presented under "Any other information on materials and methods incl. tables"

Details on test conditions:

TEST SYSTEM
- Test vessel: 21 L vessels containing 18 L test solution
- Type: open / closed: vessels were covered with plastic petri dish
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- Volume/animal: 0.314 g fish / L water

TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light
- Light intensity: 819 lux
- Aeration of dilution water: no

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

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

444 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1 090 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 978-1240 µg/L

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1 780 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Other effects:
After 6 h of exposure sublethal effects occurred at the two highest concentrations:
* 1780 µg KHSO5/L:
8 fish laying on the bottom with loss of equilibrium
3 fish breaking the surface of test solution
4 fish laying on the bottom
* 3600 µg KHSO5/L:
1 fish moving in erratic swimming pattern with loss of equilibrium

Reported statistics and error estimates:

Statistics performed with SAS software, LC50 calculated using PRobit method and Trimmed Spearman-Karber method. NOEC determined using Fisher´s exact test.

Sublethal observations / clinical signs:

Table 2:    Mortality data

Test-Substance Concentration (nominal) [µg KMPS/L]	Mortality (No. dead fish)
	Number   24 h         48 h      72 h        96 h				Percentage     24 h         48 h          72 h           96 h
0	0	0	0	0	0	0	0	0
222	0	0	0	0	0	0	0	0
444	0	0	0	0	0	0	0	0
889	4	4	4	4	20	20	20	20
1780	20*	20*	20*	20*	100	100	100	100
3560	20*	20*	20*	20*	100	100	100	100
Temperature [°C]	22.1	22.4	22.0	22.1	-
pH	7.9	7.9	7.8	7.8	-
Oxygen [mg/l]	5.8-7.1	5.2-5.6	5.3-5.9	4.5-5.3	-

 

20 fish per concentration were introduced

*  statistically significant increase in mortality as compared to control (Fisher´s exact test, p=0.05)

Validity criteria fulfilled:

yes

Remarks:

(Mortality of control animals <10%, Concentration of dissolved oxygen in all test vessels > 60% saturation)

Conclusions:

The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). The LC50 for fish was determined to be 1090 µgKMPS/L.

Executive summary:

Materials and methods

The acute toxicity of KMPS triple salt to Sheepshead minnows was determined in a static dose-response 96-h test according to the US EPA guideline 850.1075.

 

Results and discussion

The analytical verification of test concentrations resulted in recoveries ranging from 78 and 86% of nominal at test start and decreased below the LOQ (700 µg KHSO5/L) at test end. Mortality of test fish was 0, 0, 20, 100 and 100% at 222, 444, 889, 1780, 3560 µg KMPS triple salt/L, respectively. The 96-h LC50 was determined to be 1090 µg KMPS/L, based on nominal concentrations.

LC0:          444 µg KMPS triple salt/L

LC50:       1090 µg KMPS triple salt/L

LC100.       1780 µg KMPS triple salt/L

The studies performed on marine species were done using the US EPS 850.1075 guideline and therefore, the applicant feels that this data point has been properly addressed. The desgin of the test system for all aquatic organisms was done based on the properties of the chemical and after 4 pre-

test studies to determine the best desgin on the mysid shrimp.

In regards to the analytical method used, the stock solution was analysed and was determined to be 96-108% of nominal and the two highest solutions of KMPS triple salt were analysed and recoveries were from 78-86% of nominal. Given that the stock solution and two highest doses of the test solutions were within 78-108% of nominal concentrations, the applicant believes the results demonstrate that the test systems were dosed correctly and therefore, this data point is fulfilled.

Description of key information

The toxicity of KMPS triple salt to aquatic organisms was tested in three short term toxicity test to fish. Two key studies and one supporting study. To Rainbow Trout in a semi static test according to OECD Guideline 203, to the marine species Sheepshead minnows according to the US EPA guideline 850.1075. and to the Zebra fish in a semi static test also according to the OECD Guideline 203.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

42.3 mg/L

Marine water fish

Marine water fish

Effect concentration:

1.09 mg/L

Additional information

The acute toxicity test in rainbow trout was performed according to OECD guideline 203 without deviations. Fish were exposed for 96 h to 5 different concentrations. The LC 50 was calculated to be 53 mg/L. The acute toxicity of KMPS triple salt to Sheepshead minnows was determined in a static dose-response 96-h test according to the US EPA guideline 850.1075. with an LC 50 of 1.09 mg/L. An acute toxicity test in Brachydanio rerio was performed according to OECD Guideline 203 under semi-static conditions. Fish were exposed for 96 h to 6 different concentrations in order to derive a LC50. The test medium was daily renewed. The 48- and 96h LC50 were both found to be 42.3 mg/L.