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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 April 2020 to 29 June 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
18 June 2019
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 30.85 mg/L
- Sampling method: The samples were filled into glass vials and were stored in the freezer (≤ -18 °C). After 0 h, 48 hand 96 h exposure, two replicates of 6 ml each were sampled from NC and A.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution was prepared by adding 216.1 mg test item to 7 L test medium to obtain a test item concentration of 30.85 mg/L.
- Controls: negative control
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: in-house breeding at Hydrotox GmbH
- Age at study initiation: ca 2 months
- Length at study initiation: total length, Mean: 20.8 mm, Range: 18.5-24.5 mm
- Weight at study initiation (mean and range, SD): Mean: 406 mg, Range: 99 - 810 mg
- Maintenance of the brood fish: The zebrafish are cultured at 26 ± 2 °C with 14 h light : 10 h dark and aeration with air pumps. They are kept in glass tanks, equipped with external filters, at ≤ 1 fish/L. On workdays, they are fed with commercial fish food (TetraMin flake food, Tetra GmbH, Melle, Germany) and two times per week with freshly hatched Artemia salina larvae. At least every two weeks, ≥ ⅓ of the tank volume is replaced with fresh charcoal filtered tap water.

ACCLIMATION
- Acclimation period: 7 daya before the start of the test.
- Acclimation conditions: same as test
- Type and amount of food during acclimation: 5x/week with commercial fish food (TetraMin) until 24h before test start when feeding was stopped
- Feeding frequency during acclimation: daily, 5x/week
- Health during acclimation: no mortality observed
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
23.4 - 24.3 °C
pH:
7.8-7.9
Dissolved oxygen:
8.2-8.5 mg/L
Conductivity:
707 - 709 µS/cm
Nominal and measured concentrations:
Nominal: 30.85 mg/L. Measured concentrations were 100.5 - 102.4 % of the nominal concentration.
Details on test conditions:
TEST SYSTEM
- Test vessel: 7L glass tanks
- No. of organisms per vessel: 7
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: < 0.8 g wet weight fish/L

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14h light : 10h dark
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 30.85 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 30.85 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: 0
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
As no effects were observed no statistical data evaluation was performed.
Validity criteria fulfilled:
yes
Conclusions:
This acute fish limit test was performed using theThreshold Approach by applying a nominal test item concentration of 30.85 mg/L test item. The absence of any mortality as well as no observable effects of appearance and behavior in the present study indicates that, according to the Threshold Approach for Acute Fish Toxicity, fish is not the most sensitive group of test organisms after short-term exposure and no further testing in fish is required.
Executive summary:

In a 96-h acute toxicity study, zebrafish (Danio rerio) were exposed to N1,N3 -diallylpropane-1,3 -diamine dihydrochloride at the nominal concentration of 30.85 mg/L (and control) under static conditions.  No effects on mortality, behaviour or appearance were observed. The LOEC and NOEC values, based on mortality and sublethal effects, were >30.85 and >= 30.85 mg/L, respectively. 

 

This toxicity study is classified as acceptable and satisfies the guideline requirement for Short-term toxicity in fish (Danio rerio) toxicity study.

 

Results Synopsis

 

Test organism size/age: Total length (mean): 20.8 mm, ca. 2 months old juveniles

Test Type: static

                      

NOEC:  ≥ 30.85 mg/L                            

Endpoint(s) Effected: mortality, behaviour, appearance

Description of key information

In a 96h acute toxicity limit test (i.e. Threshold Approach) under static conditions according to OECD guideline 203 no effects of N1,N3 -diallylpropane-1,3 diamine dihydrochloride on zebrafish (Danio rerio) were observed at 30.85 mg/L.The NOEC is 30.85 mg/L. Fish are therefore not the most sensitive aquatic species.

Key value for chemical safety assessment

Additional information

No effects regarding mortality, behaviour and appearance were observed at the single test concentration of 30.85 mg/L.