[No public or meaningful name is available]

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid

Molecular formula:

(C14H19Na2NO14S)n

IUPAC Name:

2S,3S,4S,5R,6R)-6-[(2R,3R,4R,5R,6R)-3-acetamido-2,5-dihydroxy-6-sulfooxyoxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid

Sampling and analysis

Analytical monitoring:

yes

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Source: Szent István University, Department of Aquaculture 2100 Gödöllő, Páter Károly u. 1. – Hungary

Test conditions

Hardness:

The reconstituted water (ISO medium) had a total hardness of 246 mg/L (as CaCO3).

Test temperature:

The water temperature was measured at the start of the test and 24-hour intervals thereafter in each test vessel. The test temperature was in the range of 20.4 – 20.9°C measured in the test vessels.
The additionally measured temperature in the climate chamber was between 19.9 and 21.1°C.

pH:

The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test. The pH was measured at the start and at the end of each renewal period in each test vessel and was in the range of 7.46 – 7.86.

Dissolved oxygen:

The dissolved oxygen concentration was measured in each test vessel at the start and at the end of each renewal period and was in the range of 7.6– 8.8 mg/L

Nominal and measured concentrations:

Nominal concentrations
[mg/L nominal loading rates WAFs]
0.1 1 10 100

Details on test conditions:

Light: The test was carried out in 16-hour light and 8-hour dark cycle.

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

LOELR

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

other: ELR50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Under the conditions of this Daphnia magna acute immobilisation study the calculated and observed endpoints for the effect of Test Item were the followings:

The 24h, 48h, ELR50 value: > 100 mg/L nominal loading rate WAF
The 48h ELR100 value: > 100 mg/L nominal loading rate WAF
The 48h NOELR : 100 mg/L nominal loading rate WAF
The 48h LOELR : > 100 mg/L nominal loading rate WAF

Based on the results of this study, the Test Item had no toxic effect at saturation on Daphnia; the ELR50 results and the LOELR are higher than the solubility level of the Test Item in the test medium.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

Acute toxicity of Test Item was assessed with Acute Immobilisation Test on Daphnia magna, over an exposure period of 48 hours in a semi-static system.

Because no toxic effect was observed at the solubility level of the Test Item in the preliminary test, only this test concentration 100 mg/L Test Item nominal loading rate (WAF) at the solubility level of the Test Item in the test medium and one control group were tested in a limit test in the definitive study.

Based on the agreement with the Sponsor and due to the fact that the Test Item is an UVCB the analytical measurement was performed by TOC analysis. Only the sum of the carbon content of the Test Item could be measured this way.

Twenty animals, divided into 4 groups (glass beaker) of 5 animals each were used at the test and for the control group. All validity criteria were met during this study.

 

Under the conditions of this Daphnia magna acute immobilisation study the calculated and observed endpoints for the effect of Test Item were the followings:

 

The 24h, 48h, ELR₅₀value:                          >100 mg/L nominal loading rate WAF

The 48h ELR₁₀₀[1]value:                                 >100 mg/L nominal loading rate WAF

The 48h NOELR[2]:                                          100 mg/L nominal loading rate WAF

The 48h LOELR[3]:                                        >100 mg/L nominal loading rate WAF

 

Based on the results of this study, the Test Item had no toxic effect at saturation on Daphnia; the ELR₅₀results and the LOELR are higher than the solubility level of the Test Item in the test medium.

 

[1] Effective Loading rate.

[2] No-Observed Effect Loading rate.

[3] Lowest Observed Effect Loading rate.