[Name confidential or not 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:

other: Guideline study and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

, see "prinicples of method if other than guideline"

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

yes

Remarks:

, see "prinicples of method if other than guideline"

Principles of method if other than guideline:

The concentration of methanol in the solvent control was higher than demanded in
the guideline. As no significant immobilisation occurred during the test, this deviation
was stated as uncritical.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

8 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks on result:

other: (limit of water solubility)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

8 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks on result:

other: (limit of water solubility)

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 8 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks on result:

other: (limit of water solubility)

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 8 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks on result:

other: (limit of water solubility)

Any other information on results incl. tables

Purpose of the Study

This study was per-formed in order to evaluate the toxic potential of Sa 163 / SAT-No.

080003 towards freshwater shrimp, using the species Daphnia magna. Daphnia magna

SIRAUS, which belongs to the family of crustacea, was chosen in the guideline as a typical

paft of zoo-plancton. sponsor's intent: notification according to REACH.

Phases of the Study

Study Director of the whole study was Dipl. Ing. Manfred Muckle, Head of Deparlment

Ecotoxicology of LAUS GmbH. The person responsible for the quality assurance of the

study was Jutta Paulus, Head of Quality Assurance Unit of LAUS GmbH.

The study was divided in the following phases:

Phase 1: (Performance of the Ecotoxicity Study)

Phase 1 of the study was peformed at the test facility LAUS GmbH.

Phase 1 means the per-formance of the toxicity study against Daphnia magna, sample

preparation and shipment of the samples for phase 2. Principal Investigator for phase 1

was Mr. Muckle. For the quality assurance of this phase, Ms. Paulus was responsible.

Phase 2: Analysis of the Test Solutions

Phase 2 of the study was peformed at the test site Henkel AG & co. KGaA.

Phase 2 means the analytical determination of the test item in the test solutions. principal

Investigator for phase 2 was Dr. Matthias Frischmann. For the quality assurance of this

phase, Dr. Barbara Wiecken was responsible.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria were met. For the estimation of the EC50 of the positive control, the fit
showed sufficient statistical correspondence of the data with the dose-response-equation.
The 24h-EC50i of potassium dichromate was determined as 1.6 mg/L, lying within the demanded
range of 0.6 - 1.7 mg/L.
No significant toxicity was observed in control, solvent control and treatment.
The analytical determinations showed strong scattering single values and the measured
concentrations were above the calibrated working range. Therefore, the three retained replicates
of each sample were analysed, too, using a different, freshly calibrated working
range. The measurement of the retained samples showed also scattering single values
and most values were lower than the calibrated working range. Therefore, the limit of water
solubility was used as effective concentration for determination of the results.
As the theoretical concentration in the aquaria was about twice as high as the limit of water
solubility, un-dissolved test item was accumulated at the surface of the aqueous solution.
Therefore, the measured values were much higher than expected. As there was no toxicity
observed and the concentration exceeded the limit of water solubility during the test, this
was stated as uncritical and the result of the test is considered valid.