Registration Dossier

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-03-06 - 2007-04-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: US EPA 850.135
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: ASTM E1191-970
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentapotassium bis(peroxymonosulphate) bis(sulphate)
EC Number:
274-778-7
EC Name:
Pentapotassium bis(peroxymonosulphate) bis(sulphate)
Cas Number:
70693-62-8
Molecular formula:
H3K5O18S4
IUPAC Name:
pentapotassium bis(peroxymonosulphate) bis(sulphate)
Details on test material:
- Name of test material: KMPS triple salt
- Analytical purity: KMPS, containing 45% potassium peroxomonosulfate (KHSO5)
- Lot/batch No.: 27841
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
not indicated

Test solutions

Vehicle:
no
Details on test solutions:
not indicated

Test organisms

Test organisms (species):
Americamysis bahia (previous name: Mysidopsis bahia)
Details on test organisms:
TEST ORGANISM
- Common name: Mysids (Americamysis bahia)
- Source: in-house cultures
- Age of parental stock: < 24 h
- Feeding during test: yes
- Food type: newly hatched brine shrimp nauplii (Artemia) and commercial shrimp feed
- Amount: not reported
- Frequency: at least twice daily

BREEDING METHOD
Adults utilised for reproduction of juvenile test organisms were maintained in ABC saltwater with salinity of 18 to 21‰ and at 26°C. In the definitive test at the time of maturation adult mysids from reproduction retention chambers were paired and placed into another set of cylindrical retention chambers, brood chambers, consisting of a glass Petri dish base with a nylon screen collar.

EXAMINATION / SAMPLING
On a daily basis, dead first generation mysids were counted, identified by gender (if mature), and removed at the time of observation. Any missing mysids were also noted, but counted as dead in data analysis. Adult mysids that became impinged on the retention screens above the water line after day 12 were noted and were excluded fro the initial number of mysids in the percent survival data analyses.Where possible, gender was confirmed upon mortality and at test termination.

HANDLING OF OFFSPRING
At least fifteen juvenile mysids were collected from each test chamber and added to mesh retention chambers and placed back into the test chambers. The survival of these animals was observed over 96 hours

Study design

Test type:
flow-through
Water media type:
saltwater
Limit test:
no
Total exposure duration:
24 d
Post exposure observation period:
72 hours

Test conditions

Hardness:
Not reported
Test temperature:
24.5-25.5°C
pH:
7.43 to 7.70
Dissolved oxygen:
5.81 to 7.39 mg/L
Salinity:
20±3‰
Nominal and measured concentrations:
Nominal test concentrations: 33.3, 66.7, 133, 267, 533 µg KMPS/L
Nominal concentration of stock solution: 1.870 mg KHSO5/L

Measured concentrations of stock solution: 1.79 – 2.160 mg/L KHSO5/L, (96-116% of nominal)

Results were based on nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Size: 32 L
- Aeration: no
- Type of flow-through: using a 2-L proportional equal solvent diluter system
- Renewal rate of test solution: 163 L per day, corresponding to five volume additions per 24-h period, or cycle rate of 10 cycles/hour
- No. of organisms per vessel: 30 (15 mysids per retention chamber)
- No. of vessels per concentration (replicates): 3


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: commercial sea salt mix and laboratory fresh water consisting of well water that was demineralised by reverse osmosis
- Total organic carbon: Not reported
- Ca/Mg ratio: not reported
- Conductivity: not reported
- Salinity: 20±3‰
- Culture medium different from test medium: no


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14 h photoperiod daily
- Light intensity: wide spectrum fluorescents bulbs, 407 to 428 lux


EFFECT PARAMETERS MEASURED: Survival, growth, reproduction


VEHICLE CONTROL PERFORMED: no


RANGE-FINDING STUDY
- Test concentrations: 0, 0.111, 0.222, 0.444, 0.889. 1.78, 3.33 mg KMPS/L
- Results used to determine the conditions for the definitive study:
The mean % survival was 90, 93, 90, 0, 0, 0 and 0% in the 0, 0.111, 0.222, 0.444, 0.889. 1.78, 3.33 mg KMPS/L treatments, respectively.
Mean total lengths were 5.1, 5.2 and 4.9 mm in the 0, 0.111, 0.222 KMPS/L treatments, respectively.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: survival
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
533 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: survival
Duration:
28 d
Dose descriptor:
LC50
Effect conc.:
367 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: survival
Remarks on result:
other: 358 to 378
Duration:
28 d
Dose descriptor:
other: MATC (Maximum acceptable toxicant concentration)
Effect conc.:
378 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other:
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: juvenile survival
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: juvenile survival
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: length
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: length
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: young per female
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 267 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: young per female
Details on results:
Details are given under "Remarks on results including tables and figures"
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
SAS software, NOEC Fisher´s exact test, ANOVA, one-tailed Dunnett´s test were used.

Any other information on results incl. tables

Effects on first generation survival (%)

Nominal concentration (µg KMPS triple salt/L)

Day 7

Day 14

Day 21

Day 28

0

100

96

95

93

33.3

100

99

97

95

66.7

100

100

99

98

133

100

100

100

99

267

97

97

94

92

533

0

0

0

0*

*statistically significant reduction compared to control (Fisher´s test, p= 0.05)

Effects on second generation survival

Nominal concentration (µg KMPS triple salt/L)

Day 0

(Initial No. of animals)

Day 4

(No. of live animals)

Mean survival (%)

0

16

14

91

33.3

19

18

95

66.7

20

19

95

133

18

17

94

267

17

16

98

533

-

-

-

Effects on length (mm)

Nominal concentration (µg KMPS triple salt/L)

male

female

Day 14

Day 28

Day 14

Day 28

0

5.23 (0.0643)

6.06 (0.166)

5.46 (0.0)

5.90 (0.121)

33.3

5.05 (0.310)

5.84 (0.111)

5.22 (0.399)

5.87 (0.325)

66.7

5.31 (0.0954)

6.20 (0.284)

5.25 (0.205)

6.12 (0.132)

133

5.36 (0.139)

6.48 (0.227)

5.27 (0.162)

6.34 (0.203)

267

5.12 (0.250)

6.00 (0.236)

5.43 (0.0503)

6.27 (0.0742)

533

-

-

-

-

Values in parenthesis represent standard deviation

Effects on reproduction

Nominal concentration (µg KMPS triple salt/L)

Mysid reproduction

No. young/female

Young/female with at least two broods

0

12.2 (4.39)

14.0 (5.02)

33.3

15.9 (1.80)

17.4 (3.27)

66.7

19.2 (4.37)

21.0 (5.96)

133

18.2 (3.56)

19.0 (3.36)

267

15.0 (4.50)

16.2 (3.36)

533

-

-

      

Values in parenthesis represent standard deviation      

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
(Mortality of parent animals < 20% at test termination)
Conclusions:
The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). No clear dose-response relationship was observed, however, at the highest concentration significant effects occurred. The NOEC was similar for all parameters and was determined to be 267 µg KMPS triple salt/L.
Due to limited analytical method, only the stock solution was analysed for KHSO5. Results are based on nominal concentrations.
Executive summary:

Materials and methods

The potential of KMPS triple salt for acute and chronic effects on saltwater mysids (Americamysis bahia) exposed for 28 days in a life-cycle test was investigated according to the US EPA guideline no. 850.1350 under flow-through conditions. Toxicological endpoints were survival, growth and reproduction.

Results and discussion

After 28 days of exposure mean survival of the first generation mysids were 93, 95, 98, 99, 92 and 0% in the control, 33.3, 66.7, 133, 267 and 533 µgKMPS triple salt/L treatments, respectively, with statistically significant reduction at the highest concentration. The 96-h survival of juvenile mysids was not satistically significant different compared to the control in all treatments. The total young per female was not statistically significant different from the control at any treatment. The second brood was not statistically significant compared to the control.

NOEC = 267 µg KMPS triple salt/L adult and juvenile survival, adult body length, offspring per female

LOEC = 533 µg KMPS triple salt/L adult survival, > 267 µg KMPS triple salt/L juvenile survival, adult body length, offspring per female

EC50 (adult survival) = 367 µg KMPS triple salt/L with a 95% confidence interval of 358 to 378 µg KMPS triple salt/L