Ammonium 2-(acryloylamino)-2-methylpropane-1-sulfonate

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

Study period:

April, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

yes

Remarks:

Test item concentration of 200.0 mg/L corresponds to 80.2 mg/L as active ingredient instead of 100.0 mg a.i./L as reported in the Study Plan. This deviation was acceptable and without influence on test results.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

ammonium (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidate

EC Number:

611-646-3

Cas Number:

58374-69-9

Molecular formula:

C7H12NO4S.H4N

IUPAC Name:

ammonium (1Z)-N-(2-methyl-1-sulfopropan-2-yl)prop-2-enimidate

Test material form:

liquid

Specific details on test material used for the study:

A sample of 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt, contained in a HDPE bottle, was received by the Test Facility on March 08, 2016 (internal sample code: 2926880-001).
Test item identification : 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
Batch number : DP/MFR2134
Internal number : 2926880-001
Manufacturing date : January 10, 2016
Expiry date : July 11, 2017
Chemical name : 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt
C.A.S. number : 58374-69-9
ECC number : 421-680-9
Molecular weight : 224.28 g/mol
Empirical formula : C7H13NO4S.NH4
Purity : 50% (with water)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples of test item solution were collected from freshly prepared solution at time 0 and at the end of the test period (48 hours).
Negative control samples were sampled and analysed to verify the absence of active ingredient contamination.
Samples were labelled and analysed immediately after sampling.
Duplicate samples of the test water and the negative control were taken from the test solution; one sample was analysed, while the respective duplicates were stored as retain samples to be analysed only if necessary.

Test solutions

Vehicle:

no

Details on test solutions:

The test concentration was chosen in accordance with the results of a no GLP pre-test (range-finding test), whose relevant Raw Data were archived under the code of the present study.
The main test included only one test item concentration equal to 200.0 mg test item/L, corresponding to 80.2 mg/L as a.i. (calculated considering test item purity, 40.1% w/w, as reported in Certificate of Analysis supplied by the Sponsor).
The test medium was prepared as follows:
Prior to the test start, 504 mL of a 200.0 mg test item/L stock solution was prepared by direct weighing into reconstituted water (0.1008 g of test item into 504 mL of reconstituted water).
The obtained solution was clear and transparent with the test item completely solubilized.
A negative control with only reconstituted water was also tested.
After pH and oxygen concentration check, the test started.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The study was performed on the freshwater crustacean Daphnia magna Straus. A strain of this species was supplied by MicroBioTests Inc., Belgium in December 2011 (batch number: DM290911).
Since that time, the clone has been bred in the laboratories of the Test Facility under conditions identical to those of the test, with regard to temperature, light and water quality (see below), so that no acclimation was needed prior to testing.
It was daily fed with a fixed amount of the laboratory cultured green algae Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum) and with a suspension of the yeast Saccharomyces cerevisiae.
At the test start the organisms used in the test were less than 24 hours old and were not first brood progeny.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

As per guideline.

Post exposure observation period:

None

Test conditions

Hardness:

140 - 250 mg/L as CaCO3

Test temperature:

19.9 – 20.3 °C

pH:

Test start: 7.59 – 7.50
Test end: 7.39 – 7.55

Dissolved oxygen:

Test start: 6.42 – 6.85 mg/L
Test end: 6.57 – 6.91 mg/L

Salinity:

Not relevant.

Conductivity:

Not relevant.

Nominal and measured concentrations:

200 mg/L test material (The actual test concentration of active ingredient was analytically measured in the test item solution at time 0 and at time 48 hours of exposure.
Analytical recoveries:
110.9 % of the nominal value in the test item fresh solution
111.6 % of the nominal value in spent solution after 48 hours of exposure.

Details on test conditions:

The test was performed in glass beakers filled with 40 mL of test medium. The test vessels were covered with glass plates to reduce the loss of water and to avoid dust entry into test solutions.
The test vessels were labelled with the internal study number and all necessary additional information to ensure unmistakable identification.
For the test concentration and for the negative control, group of 20 daphnids were used divided into four replicates of five daphnids each.
The daphnids were randomly distributed to the test vessels at test initiation.
The daphnids loading rate was about 8 mL per one daphnid (5 daphnids for 40 mL, according to guideline OECD 202, 2004).

Reference substance (positive control):

yes

Remarks:

Results of most recent test performed with a reference item are reported & compared with published data to demonstrate daphnia clone used has adequate sensitivity to that substance. In current case results refer to a test of 02/16 with KCrO2 as reference.

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

200 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The NOEC of the test item 2-Acrylamido-2-methylpropanesulfonic acid, ammonium salt on Daphnia magna in an acute toxicity test under static conditions was 200 mg/L