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Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Type of information:
other: Study Re-scheduled due to an invalid first run
Adequacy of study:
key study
Study period:
August - September, 2022 (in-life phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to OECD and according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
CAS number: 56519-71-2
Vapour pressure: 0.0791 mPa (20°C)
Density: 0.93 g/cm³ (20°C)
Log Kow: 7.6
Analytical monitoring:
yes
Vehicle:
yes
Remarks:
Acetone was used as test vehicle
Details on test solutions:
The test was performed as a limit test with one loading rate of 10 mg/L test item.
The water control consisted of dilution water only. Since the test item was applied using a solvent, an additional solvent control containing the same concentration of solvent as all test concentrations (0.01 % v/v, corresponding to 0.1 mL/L) was prepared.
Test solutions were exchanged three times per week.
For preparation of test solutions, an appropriate amount of the individual acetonic application solution was added to e.g. 1000 mL of test medium.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
35 d
Nominal and measured concentrations:
The test was performed at one loading rate of 10 mg/L test item and with water and solvent controls
Details on test conditions:
The early life stages of zebrafish (Danio rerio) were exposed to one concentration of the test item, a control and a solvent control under semi-static conditions for a period of 35 d (according to Annex 2 of OECD guideline 210) with the aim to derive a NOEC (no observed effect concentration).
Due to the low solubility of the test item, it was decided to perform the test as a limit test with one loading rate only. Thus, it should be verified that no effect on fish will occur up to the highest concentration of the test item, which can be dissolved in the test media. To obtain the maximum concentration of dissolved test item highly, saturated test solutions will be prepared. Hence, a semi-static test design with a frequent media renewal two times per week was chosen.
The test will be initiated by placing fertilized eggs into test chambers. Hatching rate, mortality, growth, and behavioral abnormalities will be recorded. The test will be in accordance with the OECD guideline 210.
Key result
Duration:
35 d
Dose descriptor:
EC50
Effect conc.:
other: not determined
Remarks on result:
not determinable because of methodological limitations
Remarks:
Validity criteria were not fulfilled. The test sudy was re-sheduled

The survival rate at d35 is given in the table below

Survival rate at day 35 in%
  Nominal concentration [mg/L]
replicate control solvent control 10,0
A 85,0 95,0 60,0
B 85,0 75,0 50,0
C 95,0 75,0 30,0
D 75,0 50,0 35,0
Mean 85,0 73,8 43,8
SD 8,2 18,4 13,8
RSD 9,6 25,0 31,5

 

The validity criteria according to the OECD 210 guideline is given in the table below:

Parameter Criteria, accord. to OECD 210 Value measured   Compliance
             
Oxygen must be at least 60 % of the air saturation value throughout the test mean values: 88 - 99% fresh test solutions Yes
mean values: 86 - 92% aged test solutions
Water temperature should not differ by more than ± 1.5°C between successive days at any time during the test and should be within 26 ± 1.5°C  mean values: 26.2 - 26.4 °C   Yes
 
Hatching success must be greater than or equal to 70 % in controls dilution water control: 100% Yes
solvent control: 100%  Yes
Post hatch survival  must be greater than or equal to 75 % in controls dilution water control: 85.0% Yes
solvent control: 73.7% No

 

Validity criteria fulfilled:
no
Remarks:
Validity criteria were not fulfilled. Based on solvent control mortality, which resulted in a post-hatch survival rate of < 75 % (73.8 %), the test was invalid based on the criteria set in the OECD TG 210.
Conclusions:
The test will be start again
Executive summary:

The performance of a Fish early life stage test with Danio rerio, according to the OECD TG 210 with the
Test item: Propanediol Dicaprylate, CAS No.: 56519-71-9, was performed from Feb 25, 2022 to Apr 01, 2022. Based on solvent control mortality, which resulted in a post-hatch survival rate of < 75 % (73.8 %), the test was invalid based on the criteria set in the OECD TG 210. Thus, it was agreed to restart the study with a similar test design.
The repetition of the study is scheduled for August - September, 2022 (in-life phase).

Description of key information

The test was consiedered as not valid.


The repetition of the study is scheduled for August - September, 2022 (in-life phase).


 

Key value for chemical safety assessment

Additional information