Disodium sebacate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

- The test substance was added directly into the study beaker.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: Yara Tropical Fish s.r.l., Ivrea
- Length at study initiation: ~ 3 cm
- Weight at study initiation: ~ 0.47 g

ACCLIMATION
- Type and amount of food during acclimation: Sera sikus food
- Feeding frequency during acclimation: daily

FEEDING DURING TEST
No

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

about 228 mg of CaCO3

Test temperature:

20 - 22 °C

pH:

7.1 - 7.9

Dissolved oxygen:

7.0 - 8.9 mg/L

Nominal and measured concentrations:

- Nominal test concentration 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers (5 L)
- Material: glass
- Renewal rate of test solution (frequency): 24 h
- No. of organisms per vessel: 7
- Biomass loading rate: maximum loading < 1.0 g fish/L (ca. 0.46 g/L)

TEST MEDIUM / WATER PARAMETERS
- Ca/mg ratio: reconstituted water with Ca:Mg rate of 4:1 and a Na:K rate of 10:1


OTHER TEST CONDITIONS
- Photoperiod: artificial lighting, light period 16 h/day

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

not determinable

Details on results:

- Behavioural abnormalities: No animals of the treated group showed visible signs of abnormalities.
- Mortality of control: No animals in the control died.
- Abnormal responses: No animals of the control showed visible signs of abnormalities.

Sublethal observations / clinical signs:

- The values of dissolved oxygen, pH and temperature always remained within the acceptance limits.

Validity criteria fulfilled:

yes

Reference 2

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:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Paris Commission Guideline (PRACOM 2006): Protocols on Methods for the Testing of Chemicals Used in the Offshore Oil Industry. Part B: Protocol for a Fish Acute Toxicity Test.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was added directly into the aquaria, without using carrier or solvent. The test solutions were stirred for 1 minute. The test substance was stated to be insoluble in water, the amount of test substance added to the water in this way is referred to as nominal concentration, and should not be confused with the actual, but unknown, concentration in the water phase. The solutions were prepared by the same procedure for renewal of the test solutions afte 48 hours.

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST ORGANISM
- Common name: turbot
- Source: Animals were hatched 28.07.09 in Denmark, and were transported by car and airplane to Eurofins on 13.11.09
- Length at study initiation (range): 54 - 59 mm
- Weight at study initiation (mean): 3.6 g


ACCLIMATION
- Acclimation conditions: At Eurofins, they were held at a temperature of 16.0°C

Test type:

semi-static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

14.9-15.4 °C

pH:

Initial 8.2

Dissolved oxygen:

97 - 99 % saturation

Salinity:

34.4 per mill

Nominal and measured concentrations:

Nominal test concentration: 18 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Fill volume: 10 L
- Aeration: Yes
- Renewal rate of test solution (frequency): 48 h
- No. of organisms per vessel: 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural seawater from an unpolluted site at about 80 m depths in Byfjord was collected from a tap. The seawater was oxygenated and temperature adjusted, before use as dilution water, control and for acclimation of the fish.

OTHER TEST CONDITIONS
- Photoperiod: 12 h light / 12 h dark

EFFECT PARAMETERS MEASURED
- Lethality (number of dead organisms) was registered daily by visual observation.
- Measurements of oxygen was done daily, temperature was measured at start, while pH and salinity were measured at start, day two and day four.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Limit test

Reference substance (positive control):

yes

Remarks:

3,5-Dichlorophenol

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No mortality was observed and no behavioural abnormalities.
- Mortality of control: < 10 %

Results with reference substance (positive control):

The percentage mortality in the blank was < 10%, and the 96 hours test result with the 3,5 dichlorphenol turned out to be as expected.

Description of key information

No acute toxic effects on fresh or marine water fish were observed (Ausimont, 1999; BASF SE, 2009).

Additional information

No data on aquatic toxicity with the salt disodium sebacate are available. Only data on the acid are available:

In a 96-h acute toxicity study (BASF SE, 2009), turbot, Scophthalmus maximus were exposed to sebacic acid at nominal limit concentrations of 0 (control) and 18 mg/L under static conditions according to the Paris Commission Guideline [(PRACOM 2006): Protocols on Methods for the Testing of Chemicals Used in the Offshore Oil Industry. Part B: Protocol for a Fish Acute Toxicity Test]. The 96-h LC50 was > 18 mg/L. No sub lethal effects were observed in the groups exposed to 18 mg/L sebacic acid.

In a 96-h acute toxicity study (Ausimont, 1999), zebra fish, Danio rerio were exposed to sebacic acid at a nominal limit concentration of 100 mg/L under semi-static conditions according to OECD Guideline 203. The 96-h LC50 was > 100 mg/L. No sub lethal effects were observed in the groups exposed to 100 mg/L of sebacic acid.

However, according to ECHA guidance R7b effects can be extrapolated from the anion or cation, whichever has the most toxic effect, if no data are available on a salt.

If the effect is related to only one of the ions, the classification of the salt should use the effect concentration multiplied by the salt/ion molecular weight ratio.

The molecular weight ratio between salt and ion is 246 : 202 (1.22)

Based on this correction the LC 50 for disodium sebacate was determined to be 22 mg/L in the test with marine fish and >122mg/L in the test with freshwater fish.