Fatty acids, tall-oil, polymers with glycidyl neodecanoate

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

Study period:

From October 10, 2016 to March 20, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Temperature lower than stated in study plans. Fish fed with flake food and moskito larvae. The deviations did not affect the outcome of the study.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

The substance was tested in the form of a water-accommodated fraction (WAF) prepared by pipetting 105 μL/L, corresponding to the nominal load 100 mg/L (based on a specific density of 0.95 g/mL) on the surface of tap water and stirring for 24 h. The lower phase of the resulting solution was used as test solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Sexually immature young fish, length 2 +/- 1 cm
The animals were obtained from a commercial supplier. Before being used for the test, the fish were kept for at least 12 days under test conditions. During this period, mortality did not surpass 5%.
Supplier: Dehner Garten Center, 67433 Neustadt
Date of arrival: 19. Oct 2016

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

20.5 - 21.8°C

pH:

7.8 - 8.0

Dissolved oxygen:

8.6 - 9.3 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L (WAF)
Mean measured concentration (geometric mean): 4.9 mg/L

Details on test conditions:

Vessels polyethylene aquaria
Medium chlorine-free tap water
Feeding three times a day with warm-water fish food,and daphnia
totalling about 1-2% of body weight per day
Photo period 12/12 hours, using neon tubes
Temperature 23 +/- 2 °C

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 4.9 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to a nominal concentration of > 100 mg/L

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 4.9 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to a nominal concentration of >= 100 mg/L

Details on results:

In the control and in the treatment, only one fish died which can be stated as not significant. No abnormal behaviour of the surviving fish was observed.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h EC50 was > 4.9 mg/L (geometric mean), i.e. > 100 mg/L (nominal). The 96 h NOEC was ≥ 4.9 mg/L(geometric mean), i.e. ≥ 100 mg/L (nominal).

Executive summary:

A study was conducted to determine the toxicity of the test substance to Zebra fish (Danio rerio) under static conditions according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Groups of 7 fish were exposed to a water accommodated fraction of the test substance prepared by pipetting 105 μL/L, corresponding to the nominal load 100 mg/L (based on a specific density of 0.95 g/mL), on the surface of tap water and stirring for 24 h. The lower phase of the resulting solution was used as test solution. At the start and at the end of the test, test substance content was determined using dissolved organic carbon (DOC) determination. In the control and treated groups, only one fish died which was regarded as not significant. Because of the poor solubility of the test substance, significant differences between nominal and measured concentration were observed. The results are therefore expressed as geometric mean of the measured concentrations. Under the study conditions, the 96 h EC50 was > 4.9 mg/L (geometric mean), i.e. > 100 mg/L (nominal). The 96 h NOEC was ≥ 4.9 mg/L(geometric mean), i.e. ≥ 100 mg/L (nominal) (Muckle, 2017).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

4.9 mg/L

Additional information

A study was conducted to determine the toxicity of the test substance to Zebra fish (Danio rerio) under static conditions according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Groups of 7 fish were exposed to a water accommodated fraction of the test substance prepared by pipetting 105 μL/L, corresponding to the nominal load 100 mg/L (based on a specific density of 0.95 g/mL), on the surface of tap water and stirring for 24 h. The lower phase of the resulting solution was used as test solution. At the start and at the end of the test, test substance content was determined using dissolved organic carbon (DOC) determination. In the control and treated groups, only one fish died which was regarded as not significant. Because of the poor solubility of the test substance, significant differences between nominal and measured concentration were observed. The results are therefore expressed as geometric mean of the measured concentrations. Under the study conditions, the 96 h EC50 was > 4.9 mg/L (geometric mean), i.e. > 100 mg/L (nominal). The 96 h NOEC was ≥ 4.9 mg/L(geometric mean), i.e.≥ 100 mg/L (nominal) (Muckle, 2017).