Addition reaction products of conjugated sunflower-oil fatty acids and tall-oil fatty acids with maleic anhydride

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given; test procedure according to national standards (DIN); conducted under Quality Assurance Programme; minor restrictions in design (study conducted for 48 h instead of 96 h), but otherwise adequate for assessment

Qualifier:

according to guideline

Guideline:

other: DIN guideline 38412, part 15

Deviations:

no

GLP compliance:

yes

Remarks:

Quality Assurance Programme/GLP standards not specified

Analytical monitoring:

yes

Details on sampling:

Initial exposure levels were measured in the control and in the test solution.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fraction (WAF)
A saturated solution (initial weight: 150 mg/l) was prepared in reconstituted water and was stirred overnight. After a filtration step over a folded paper filter (595 1/2; diameter 320 mm, Schleier & Schuell, D-37582 Dassel) the filtrate was used without further treatment.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden Orfe
- Source: fish farm Eggers, Hohenwestedt, Germany
- Length at study initiation: 5-8 cm
- Corpulence factor: 0.8-1.1 g/cm3
- Feeding: Tetra Menü Spezialfutter
- Feeding during test: fish were not fed during the test

ACCLIMATION
- Acclimation period: at least 7 days
- Acclimation conditions: 20 - 21 °C
- Diluent water: tap water of Karlsruhe with the following quality:
acid capacity KS(4.3): 4.75 - 4.77 mmol/L
water hardness: 2.83 - 3.14 mmol/L
calcium Ca2+: 2.41 - 2.60 mmol/L
magnesium Mg2+: 0.42 - 0.54 mmol/L
sodium Na+: 0.28 - 0.33 mmol/L
potassium K+: 0.05 - 0.06 mmol/L
pH-value: 7.39 - 7.49
aeration: at least 80% of the air saturation value
- Type of food: Tetra Menü Spezialfutter
- Health during acclimation: fish were in good health

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

2.7 mmol CaCO3/L

Test temperature:

20.3-20.4 °C

pH:

7.96 (control)
7.15 (saturated test solution)

Dissolved oxygen:

At least 80% of the air saturation value

Nominal and measured concentrations:

nominal loading rate: 150 mg/L
TOC-values at test start:
test solution (WAF): 14.4 mg/L
control: 0.054 mg/L

Details on test conditions:

TEST SYSTEM
- Volume: 10 L
- Aeration: permanent during the test duration
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 – 5.6 g/L (corpulence factor K = 0.8-1.1 g/cm³, length = 5-8 cm)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Total organic carbon: 0.054 mg/L
- Acid capacity, KS(4.3): 0.7-0.9 mmol/L
- Inorganic salts: CaCl2: 2.2 mmol/L, MgSO4: 0.5 mmol/L, NaHCO3: 0.64 mmol/L
- Ca/mg ratio: 4:1
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality recorded after 48 h

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

48 h

Dose descriptor:

LL100

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

In a saturated solution of the test material in dilution water no mortality of fish after 48 hours was observed. Sub-lethal effects were not reported.

Validity criteria fulfilled:

yes

Description of key information

48-h LC50 (based on loading rates)  >150 mg/L for Leuciscus idus (DIN guideline 38412, part 15)

Additional information

LC50 for freshwater fish: > 150 mg/L

The results indicate that the test material is not toxic to fish up to the limits of its water solubility and a NOEC and thus a PNEC cannot be determined.