Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27.03.2006 - 19.05.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the appropriate guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
Test substance concentrations measured in the test solution decreased by more than 20% during the test. The results of the study were therefore based on the mean measured concentrations. This minor deviation did not affect the outcome of the study.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Test substance concentrations measured in the test solution decreased by more than 20% during the test. The results of the study were therefore based on the mean measured concentrations. This minor deviation did not affect the outcome of the study.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Appearance of Potassium permanganate - Dark violet, purple crystalling powder with bronze lustre.
Batch number - 69
Impurities - Manganese dioxide - cc 0.1%
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Potassium permanganate is being used as a surrogate for sodium permanganate. Read-across from potassium permanganate to sodium permanganate is appropriate from the ecotoxicological point of view as the most toxicologically relevant part of the substances is the same (permanganate). The contribution of the sodium/potassium ions to the toxicity of the respective substances is likely to be minimal. The toxicity of both substances is therefore likely to be very similar and will be dominated by local (site of contact) irritant/corrosive effects and systemic toxicity due to the absorption of manganese ions.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Concentrations were verified analytically at the start and end of each 24 hour exposure period. Samples were stored at room temperature prior to analysis.

Test solutions

Vehicle:
no
Details on test solutions:
The test material was soluble in water in the range of concentration tested.

Test organisms

Test organisms (species):
Poecilia reticulata
Details on test organisms:
Fish were delivered from BioTest s.r.o., Konarovice (Czech Republic). Length of fish 2.0-3.0 cm, 3-4 months old. Fish were acclimatised for 7 days in dilution water; they were not fed during 72 hours prior to the start of the test. 10 fish per concentration level.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not applicable

Test conditions

Hardness:
The dilution water should have a sum value of Ca + Mg ions of 2.5 mmol/L. Measured values were 2.63, 2.61, 2,51 and 2.53 mmol/L at 0, 24, 48 and 72 hours.
Test temperature:
Measured range was 21.6 to 22.0 °C
pH:
Measured range was 7.7 - 7.9.
Dissolved oxygen:
Measured range was 7.0 - 8.6
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentration range - 0 (control), 0.3, 0.4, 0.5, 0.7, 1.0, 1.4 & 1.9 mg/l. Mean measured concentrations were 0.22, 0.29, 0.35, 0.47, 0.69, 1.09 and 1.67 mg/L.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
1.51 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 1.22-1.79 mg/L
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
0.7 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 0.62-0.78 mg/L
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
0.56 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 0.38-0.74 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.47 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 0.36-0.58 mg/L
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.35 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Results with reference substance (positive control):
The sensitivity of the test species is periodically verified by testing the reference substance, potassium dichromate. The results of the verification testcarried out in April 2006 gave a 96h LC50 of 142 mg/L (95% CI limits of 108-177 mg/L). This result is within the range for potassium dichromate provided by the Centre for Assessment of Laboratories of T.G. Masaryk Water Research Institute Prague in 2004 of between 90.2-185.6 mg/L.
Reported statistics and error estimates:
The NOEC and LC100 values were identified by direct observation. The LC50 values were calculated by means of software 'Toxicity' (product of Water Research Institute, Ostrava, Czech Republic. For the calculation of LC50 and NOEC values time-weighted mean concentrations were used.

Any other information on results incl. tables

Fish cumulative mortality results

Mean measured concentration (mg/L)

Cumulative % mortality

2 hours

24 hours

48 hours

72 hours

96 hours

Control

0

0

0

0

0

0.22

0

0

0

0

0

0.29

0

0

0

0

0

0.35

0

0

0

0

0

0.47

0

10

10

20

50

0.69

0

0

50

100

100

1.09

0

0

100

100

100

1.67

0

90

100

100

100

Mean measured (geometric) concentrations of the test substance during the semi-static test

Nominal Conc.

(mg/L)

Measured concentration (mg/L)

Geometric mean measured

[mg/L]

0 hours (fresh)

24 hours (old)

24 hours (new)

48 hours (old)

48 hours (new)

72 hours (old)

72 hours (new)

96 hours (old)

0.3

0.2406

0.1818

0.3430

0.2070

0.3736

0.0819

0.2547

0.1508

0.22

0.4

0.3141

0.2559

0.4388

0.2956

0.4564

0.1232

0.3499

0.1712

0.29

0.5

0.4146

0.3395

0.4272

0.3686

0.4878

0.1958

0.3955

0.2658

0.35

0.7

0.6387

0.3429

0.6076

0.4989

0.6853

0.3075

0.6014

0.2492

0.47

1.0

0.8669

0.6957

0.9612

0.5739

0.9554

0.1523

0.8601

0.7325

0.69

1.4

1.235

1.026

1.309

0.5514

1.324

1.021

1.229

1.145

1.09

1.9

1.877

1.427

1.760

1.562

1.842

1.557

1.766

1.603

1.67

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
A 96 hour acute semi-static toxicity study with the guppy (Poecilia reticulata) was performed to assess the toxicity of potassium permanganate. The study was performed according to GLP and the OECD 203 Test Guideline. The 96 hour LC50 was calculated to be 0.47 mg/L, with 95% confidence limits of 0.36 to 0.58 mg/L (based mean measured concentrations), the corresponding NOEC was 0.35 mg/L.
Executive summary:

A 96 hour acute semi-static toxicity study with the guppy (Poecilia reticulata) was performed to assess the toxicity of potassium permanganate. The study was performed according to GLP and the OECD 203 Test Guideline. The 96 hour LC50 was calculated to be 0.47 mg/L, with 95% confidence limits of 0.36 to 0.58 mg/L (based mean measured concentrations), the corresponding NOEC was 0.35 mg/L.