Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo)-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfonyl)benzenesulfonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 22, 2006 to September 12, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sampling schedule for chemical analysis: At 0 and 48 h
- Sample storage conditions before analysis: Routinely, the samples were analysed immediately. Otherwise, they were stored overnight deeply frozen and protected from light.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus
- Sex: Parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Age at study initiation: Neonates
- Food type: Green algae (Desmodesmus subspicatus)
- Frequency: Ad libitum

ACCLIMATION
A population of parthenogenetic females of synchronized age structure which had been maintained for more than 15 years in the test facility under constant temperature conditions (20±1°C) at a 16:8 h light-dark photoperiod (illumination: <1000 lux) were used in the study. The culture water (so-called 'M4 medium') was partly renewed once a week.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

295 mg CaCO3/L

Test temperature:

20.4-20.5°C

pH:

7.9

Dissolved oxygen:

8.5-8.6 mg/L

Nominal and measured concentrations:

- Nominal concentration: 100 mg/L
- Measured concentration: Quantification was carried out by HPLC
0 h = 103.5 mg/L
48 h = 103.2 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL glass beakers holding 10 neonates in 20 mL of test medium
- Aeration: None
- Type of system: Static
- No. of organisms per vessel: 10 neonates per vessel
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Feeding: No feeding during exposure period

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water ('M4 medium'), originally described in 'Water Research 24 (9): 1157-1167', prepared according to the recommendations of Bundesgesundheitsamt Berlin

OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark
- Test solution preparation: 105.3 mg of the test substance was added to 1 L of dilution water
- Test concentrations: 100 mg/L (nominal)

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Immobilization in control: 0
- Immobilization in test: 0

Table 1: EC50 of the test substance Time [h] EC 50 [mg/L] (nominal concentration) 24 >100 48 >100

Analytical measurement of test substance concentration was carried out by HPLC. The measured concentrations were 103.51 mg/L at 0 h, and 103.19 mg/L at 48 h.

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 48 h EC50 and NOEC of the test substance were >100 mg/L and ≥100 mg/L (nominal concentration) respectively.

Executive summary:

A limit test was conducted to determine the acute toxicity of the test substance to Daphnia magna according to EU Method C.2 (equivalent or similar to OECD Guideline 202), in compliance with GLP.

In this test, 2 replicates of 10 Daphnia magna neonates were exposed to the test substance at a nominal concentration of 100 mg/L under static conditions for 48 h. Immobility was recorded at 24 and 48 h. The analytical concentration of the test substance was measured by HPLC method and was found to be 103.5 mg/L at 0 and 103.2 mg/L at 48 h.

Under the test conditions, the 48 h EC50 and NOEC of the test substance were >100 mg/L and ≥100 mg/L (nominal concentrations), respectively.

Description of key information

The 48 h EC50 and NOEC of the test substance were >100 mg/L and ≥100 mg/L (nominal concentrations), respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

A limit test was conducted to determine the acute toxicity of the test substance to Daphnia magna according to EU Method C.2 (equivalent or similar to OECD Guideline 202), in compliance with GLP. In this test, 2 replicates of 10 Daphnia magna neonates were exposed to the test substance at a nominal concentration of 100 mg/L under static conditions for 48 h. Immobility was recorded at 24 and 48 h.The analytical concentration of the test substance was measured by HPLC method and was found to be 103.5 mg/L at 0 and 103.2 mg/L at 48 h. Under the test conditions, the 48 h EC50 and NOEC of the test substance were >100 mg/L and ≥100 mg/L (nominal concentrations), respectively (Weyers, 2006c).