Pyridinium, 3-[(diethylamino)carbonyl]-1-(3-sulfopropyl)-, inner salt

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:

18.11.2014 to 20.11.2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

(2004)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

(2008)

Test guideline 3

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Version / remarks:

(2010)

GLP compliance:

yes (incl. QA statement)

Remarks:

LAUS GmbH, Auf der Schafweide 20, D-67489 Kirrweiler (Germany)

Test material

Test material information

Constituent 1

Reference substance name:

3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium

EC Number:

807-112-6

Cas Number:

1393708-17-2

Molecular formula:

C13H20N2O4S

IUPAC Name:

3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Pyridiniumsulfonate
- Physical state: white powder
- Analytical purity: 99.8% (HPLC)
- Impurities (identity and concentrations):
- Purity test date:
- Lot/batch No.: CHZT000001
- Expiration date of the lot/batch: 2/2016
- Stability under test conditions: stable
- Storage condition of test material: test material stored in closed vessel dark and dry at room temperature (min. -5 - max. +40°C)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

The content of the test item in the test vessels was determined at the beginning and at the end of the test via HPLC/UV

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea (Daphnia magna Straus)
- Strain: Berlin
- Source: Umweltbundesamt Berlin
- Age at study initiation (mean and range, SD): <=24 h
- Method of breeding: Daphnia magna is bred in the LAUS GmbH throughout the year. The animals multiply by parthenogenesis. The husbandry is performed similar to the method described in EN ISO 6341: vessels: preserving glasses (nominal volume: 2 L), medium: M4-Medium, medium renewal: twice a week, food: unicellular green algae (Desmodesmus subspicatus), photo period: 16/8 h using neon tubes, temperature: 20 +/- 2°C
- Feeding during test: no

ACCLIMATION
- Acclimation period: not necessary
- Acclimation conditions (same as test or not): Switching from M4-medium (husbandry) to ISO medium (test) had been shown not to cause any detrimental effects for test Daphnia

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

dilution water: 250 mg CaCO3/L

Test temperature:

19.2-19.8°C

pH:

pH value in the test media and the control at time 0 and after 48 h: 7.8

Dissolved oxygen:

dissolved oxygen in the test media and the control at time 0 and after 48 h: 8.5-8.7 mg/L

Nominal and measured concentrations:

nominal: 100 mg/L
measured
a. t=0 h: 100.84 mg/L (corresponding to 101% of nominal)
b. t=48 h: 105.64 mg/L (corresponding to 105.64% of nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass/50 mL/-/20 mL
- Aeration: aeration of dilution water
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- Renewal rate of test solution (frequency/flow rate): test conducted under static conditions
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): no vehicle used

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: yes, switching from M4-medium (husbandry) to ISO medium (test) had been shown not to cause any detrimental effects for test Daphnia
- Intervals of water quality measurement: pH and dissolved oxygen were measured at the beginning and at the end of the test

OTHER TEST CONDITIONS
- Adjustment of pH: pH of dilution water was adjusted to pH 7.8 +/-0.2
- Photoperiod: diffuse lighting
- Light intensity: not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: not reported

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

Potassium dichromate was used as positive control in a current reference study which was performed in August 2014. The 24 h EC50 was determined as 1.2 mg/L, lying within the demanded range of 0.6-1.7 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In a limit test conducted according to OECD Guideline 202, EU Method C.2, and ISO 6341 15, the 48 h EC50 and NOEC were determined to be >100 mg/L and >=100 mg/L (nominal each), respectively.

Executive summary:

The acute toxicity of pyridiniumsulfonate towards Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test), EU Method C.2 (Acute Toxicity for Daphnia; 2008), and ISO 6341 15 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea) 2010). 20 daphnids (5 daphnids/replicate) were exposed to pyridiniumsulfonate for 48 h at a nominal concentration of 100 mg/L under static conditions. The test material concentration was determined by HPLC/UV measurements. The 48 h EC50 and NOEC were determined to be >100 mg/L and >=100 mg/L (nominal each), respectively.

The study is considered as reliable without restriction and fulfills the requirements of the guideline.

Results Synopsis
Test organism: Daphnia magna Straus (<=24 h old). Concentrations in nominal values, analytically verified.
Test Type: static
48 h EC50: >100 mg/L

48 h NOEC>=100 mg/L

Endpoint(s) Effected: mobility