(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid

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:

07 June - 16 July 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Test material: Balsalazide acid
- Appearance: Slightly yellow brown powder
- Batch number: 0400
- Expiry date: April 2019
- Purity: >98%
- Storage: Room temperature
- Stability: 12 months

Analytical monitoring:

yes

Details on sampling:

Samples were taken from the treated vessels at the start and end of the test.

Vehicle:

no

Details on test solutions:

The test solution was sonicated for 40 minutes to homogenise the sample.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: Breeder in Eurofins Biolab Test Facility
- Age: 6 - 24 hours
- Feeding during test: None

ACCLIMATION
- Type and amount of food: Green alga Pseudokirchneriella subcapitata and Saccharomices cerevisiae
- Water change: 3 times per week
- Photoperiod: 16 hours of light, 8 hours of darkness

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

Between 140 and 250 mg CaCO3/L

Test temperature:

20°C ± 2°C

pH:

Control: 7.83 - 7.93
Test concentration: 7.10 - 7.67

Dissolved oxygen:

> 3 mg/L

Nominal and measured concentrations:

Range finding test: Ten fold dilutions from 100 mg/L to 0.01 mg/L
Definitive test: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beaker (500 mL)
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Aeration: None

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water containing:
- Bihydrated calcium chloride: 11.76 g/L
- Eptahydrated magnesium sulphate: 4.93 g/L
- Acid sodium bicarbonate: 2.59 g/L
- Potassium chloride: 0.23 g/L
- Deionised water: Up to 1000 mL volume

OTHER TEST CONDITIONS
- Photoperiod: None

RANGE-FINDING STUDY
- Test concentrations: Ten-fold dilutions from 100 mg/L to 0.01 mg/L
- Results used to determine the conditions for the definitive study: Yes

EFFECT PARAMETERS MEASURED: The immobilisation of the test organisms was evaluated at 24 and 48 hours.

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

Details on results:

Stability of the test item: The sample is considered stable because the measured concentrations of the test item at the end of the test have been maintained within ± 20% at the beginning of the test (see Table 1).

Table 1: Stability of the test item

Nominal concentration	Measured concentration (mg/L)		% concentration Variation	Stability
	T=0	T=48 h
Treated (100 mg/L)	95.5	93.4	2.11	Stable

 

Validity criteria fulfilled:

yes

Remarks:

Immobilised Daphnia in the control: 0%

Conclusions:

According to the results of the test, the EC50 (48 hours) for invertebrates is estimated to be >100 mg/L based on nominal concentrations of the test item “Balsalazide acid”.

Description of key information

A GLP study was performed in accordance with OECD Guideline 202 to assess the toxicity of the test material, Balsalazide acid, to Daphnia magna. According to the results of the test, the EC50 (48 h) was > 100 mg/L (nominal).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L