[No public or meaningful name is available]

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04. June - 02. October 2019

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6-08697-43
- Expiration date of the lot/batch: 27. Sep. 2022

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a closed vessel at room temperature (18.2 – 23.7 °C)
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: assumed stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: assumed unreactive

Analytical monitoring:

yes

Details on sampling:

The 176 mg/L test item solution in tap water (or blank solution) was 20fold diluted before
measurement: 2.5 mL of the test solution was given into a 50 mL measuring flask, diluted
with 37 mL of tap water, 1 mL ascorbic acid and 2 mL acidic molybdate solutions were given
under stirring conditions and the flask was filled up to 50 mL with Tap water. The solution
was measured after 10 min at 880 nm via photometer.
The reagent blank solution was prepared in the same way, directly with 40 mL tap water
(without dilution).

Vehicle:

no

Details on test solutions:

On the day of the start of the study, the test solution (real concentration: 176.1 mg/L) in
drinking water was directly prepared.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Danio rerio
- Strain: HAMILTON-BUCHANAN
- Source: The animals were obtained from a commercial supplier. Dehner Garten Center, 67433 Neustadt
- Age at study initiation (mean and range, SD): not stated
- Length at study initiation (length definition, mean, range and SD): sexually immature young fish, length 2  1 cm
- Weight at study initiation (mean and range, SD): not stated

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: warmwater fishfood
- Feeding frequency during acclimation: twice a day
- Health during acclimation (any mortality observed): During 7 days, no mortality occurred.

FEEDING DURING TEST
same as during acclimation

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

0.88 mmol/L

Test temperature:

23.1 – 25.0 °C

pH:

7.6 - 8.0

Dissolved oxygen:

7.1 - 8-1 mg/L

Salinity:

not applicable (freshwater

Conductivity:

250 µS/cm

Nominal and measured concentrations:

nominal: 176 mg/L Test item, 100 mg/L total solids
measured: 151.1 mg/L Test item, 86.1 mg/L total solids, geometric mean

Details on test conditions:

24 hours before the start of the test, the test fish were no longer fed.
Date: 15. – 19. July 2019
Treatment 176 mg/L (= 100 mg/L active ingredient (nominal) due to
43.1% water content of test item)
Test Design static
Medium renewal none
Duration 96 hours
Loading 1 fish/L
Vessels: glass aquaria, maximal volume 12 L
Aeration: accomplished with glass tubes
Feeding: none
Photo period: 12/12 hours using neon tubes
Temperature: 23.1 – 25.0 °C
pH adjustment: none
Replicate (Treatments): 1 vessel, each containing 7 L test solution and 7 fish
Replicate (Blank Control): 1 vessel, containing 7 L tap water and 7 fish
Observations were made every 24 hours, measuring pH and O2-concentration of the test
solution in each vessel and documenting mortalities.
The content phosphorus (total P and P from orthophosphate) of the test item in the test solutions was measured at the beginning and at the end of the study.
A fish was considered dead, if no visible movement could be observed, and if touching of
the caudal peduncle produced no reaction.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 176 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 176 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 176 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

The following results for the test item Reaction mass of potassium sodium phosphotartrate
and potassium sodium tartrate and potassium sodium orthophosphate (aqueous solution)
(EC-947-073-3) could be determined:
96h-NOEC ≥ 176 mg/L test item

96h-EC50 > 176 mg/L test item

Executive summary:

One experiment was performed.
The toxicity againstDanio reriowas tested using a static test design. The control and the
tested concentration showed no mortality.
The study was performed as a limit test at the concentration 176.1 mg/L (= 102 mg/L solid
components due to 43.1% water content and on solids content of 56.9 % of the test item).
The test item consists of 3 constituents. The content of the test item in the test solutions was
determined once by the concentration of constituent 1 and once by the concentration of
constituent 3.
At the beginning and at the end of the test the content of total P (constituent 1 and 3) and P
from orthophosphate (constituent 3 only) in the test solutions was measured via ICP-OES
and via photometer.
The measured test item concentration based on measurement of orthophosphate (constituent 3) was 102 % of the nominal concentration at the beginning and 92 % of the nominal
concentration at the end of the test.
The measured test item concentration based on measurement of total P (constituent 1 and
3) was 94 % of the nominal concentration at the beginning and 78 % of the nominal concentration at the end of the test. The mean exposure concentration based on the geometric
mean of the 2 measured concentrations however was 86 % of the nominal concentration.
Therefore, the biological results were based on the nominal concentration (see OECD 203
§ 6). The results were presented, based on the test item concentration and on the concentration of the active ingredient based on solids content of 56.9 % of the test item.
No observations were made which might cause doubts concerning the validity of the study
outcome. All validity criteria were met.
The result of the test is considered valid.

Description of key information

The following results for the test item Reaction mass of potassium sodium phosphotartrate

and potassium sodium tartrate and potassium sodium orthophosphate (aqueous solution)

(EC-947-073-3) could be determined:

96h-NOEC ≥ 176 mg/L test item

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

176 mg/L