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Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2018-11-07 to 2019-02-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Version / remarks:
2013
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
Dimethylformamide (DMF)
Details on test solutions:
Limit concentration: One limit concentration of 1 µg/L was tested since the water solubility of the test item is < 1 µg/L. The test concentration was prepared by adding the dissolved test item to dilution water in solvent (DMF) as described above. Dilution water control and a solvent control were tested in parallel.

Solvent: With regard to the low solubility of the test item in water, Dimethylformamide (DMF) was used as solvent. The solvent concentration was the same in the limit concentration and the solvent control (0.05 mL/L). DMF from the supplier ROTH (purity ≥ 99.9%) was used.

Stock solution: The stock solution was prepared every 3 to 4 days. Syringes were filled with the freshly prepared stock solutions every 3 to 4 days.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
All fish used in the test were gained at Noack Laboratorien GmbH from a single brood stock (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin, Germany)
A breeding stock of unexposed, mature zebrafish with an age of 8 months was used for the egg production. Fish were free of macroscopically discernable symptoms of infection and disease. Spawners were maintained in aquaria with a loading capacity of a minimum of 1 L water per fish.
- Temperature: 25 ± 2 °C
- Dissolved oxygen concentration > 60 % of air saturation value
- pH value: 6 – 8.5
- Photoperiod: 16 h light / 8 h dark cycle (2 transition periods, 30 minutes each)
- Diffuse light (7 – 750 lux on water surface)
- Food: Artemia salina nauplii, 48 hours old, ad libitum; Daphnia magna, juvenile and adult daphnids, ad libitum; dry food sera vipan SERA, ad libitum.
- No disease treatments were administered.

Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
36 d
Remarks on exposure duration:
30 days post-hatch
Hardness:
57 - 62 mg/L CaCO3
Test temperature:
25.2 - 26.8 °C
pH:
6.25 - 7.91
Nominal and measured concentrations:
1µg/L
Reference substance (positive control):
no
Duration:
30 d
Dose descriptor:
NOEC
Effect conc.:
1 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
number hatched
Duration:
30 d
Dose descriptor:
LOEC
Effect conc.:
> 1 µg/L
Conc. based on:
test mat.
Basis for effect:
number hatched
Details on results:
Egg Fertilization Rate:
The egg fertilization rate, determined on study day 0 (start of the exposure) was 75 %.
Eggs were fully covered with the respective test solutions during fertilization check.
121 eggs were introduced in the control media and 31 of these eggs were discarded.
121 eggs were introduced in the solvent control media and 29 of these eggs were discarded.
125 eggs were introduced in the limit concentration and 32 of these eggs were discarded.
In total 92 eggs of 367 introduced eggs were discarded, resulting in a fertilization rate of 75%.
Hatch and Definition of Post Hatch Day 0:
Hatch began on study day 3 in the controls, solvent control and the test item concentration and continued until study day 6. Study day 6 was determined to be post hatch day 0 (PHD 0) with a hatching rate of 90 % in the control, 91 % in the solvent control and 95 % in the test concentration. No further hatch was observed after day 6. The two remaining eggs in the solvent control replicate 1 which did not hatch were removed as dead on study day 8.
Swim-up:
Swim-up was observed for a 4-day period from study days 4 to 7 (see Table 7). Newly hatched fry began to swim up on study day 4 (PHD -2). On study day 7 (PHD 1), all surviving larvae had swum up.
Fry Survival (Post-Hatch Survival):
The post-hatch survival in the control replicates met the validity criteria of the guideline (required: ≥ 75 %). The fry survival (post-hatch survival) at the end of the study was 93 % in the control and 96 % in the solvent control. The post-hatch survival in the limit concentration was 88 %.
Cumulative Survival (Mortality):
The cumulative survival at the end of the exposure, related to the number of eggs introduced on day 0 was 84 % in the control group and 88 % in the solvent control group. The overall survival in the limit concentration of 1 µg/L (nominal loading) was 84 %.
Fry Growth:
Fry growth, expressed as length and wet weight, was measured on study day 36 (PHD 30) from all survivors. Pooled wet weights based on replicate means.The coefficients of variations (length: between and within replicates, weight: between replicates) well met the 90th percentiles coefficients of variations as stated in the guideline.


Reported statistics and error estimates:
No statistically significant difference was detected between the dilution water control and the solvent control and between the test item group and the combined data of both controls. In conclusion under the conditions of this test the test item did not affect early life stages of the zebrafish at a concentration at or above the limit of water solubility.

NOEC, LOEC, ECxValues of Hatchability and Fry Growth

                  Based on the nominal loading of the test item [µg/L]

 

Parameter

Hatchability

Fry Growth
expressed as:

Length

Weight

NOEC

[µg/L]

1

1

1

LOEC

[µg/L]

> 1

> 1

> 1

LC0

1

1

1

 

 

NOEC, LOEC, LCxvalues of Post Hatch Survival and Overall Survival

                  Based on the nominal loading of the test item [µg/L]

 

Parameter

Post hatch survival

Overall survival (Mortality)

NOEC

[µg/L]

1

1

LOEC

[µg/L]

> 1

> 1

LC0

1

1

 

Validity criteria fulfilled:
yes
Conclusions:
Laurylacrylat 12 caused no significant effects on Zebrafish in an early life stage test, 30 days post hatch when tested with a loading of 1 µg/L in flow-through test resulting in a time-weighted arithmetic mean measured test item concentration of 0.104 µg/L.
For the parameter hatchability the NOEC was 1 µg/L. Therefore the LOEC for hatchability was determined to be > 1 µg/L. For the parameters post hatch and overall survival (mortality) the NOEC was 1 µg/L. Therefore, the LOEC for these parameters was determined to be > 1 µg/L. For the parameter fry growth (expressed as length and fresh weight) the NOEC was 1 µg/L. Therefore, the LOEC for these parameters was determined to be > 1 µg/L.
All effect values are given based on the based on the nominal loading of the test item Laurylacrylat 12, which was above the limit of solubility in water, since a stable concentration of the test item above the LOQ could not be established.

Description of key information

Laurylacrylate 12 was tested in an early life stage test, the NOEC (hatchability) was 1µg/L, the LOEC was determined to be > 1µg/L (the mean measured test item concentration was 0.104 µg/L).

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
1 µg/L

Additional information

Laurylacrylat 12 caused no significant effects on Zebrafish in an early life stage test, 30 days post hatch when tested with a loading of 1 µg/L in flow-through test resulting in a time-weighted arithmetic mean measured test item concentration of 0.104 µg/L.

For the parameter hatchability the NOEC was 1 µg/L. Therefore the LOEC for hatchability was determined to be > 1 µg/L. For the parameters post hatch and overall survival (mortality) the NOEC was  1 µg/L. Therefore, the LOEC for these parameters was determined to be > 1 µg/L. For the parameter fry growth (expressed as length and fresh weight) the NOEC was 1 µg/L. Therefore, the LOEC for these parameters was determined to be > 1 µg/L.

All effect values are given based on the based on the nominal loading of the test item Laurylacrylat 12, which was above the limit of solubility in water, since a stable concentration of the test item above the LOQ could not be established.