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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
This study was designed to assess the toxic effects of the test compound on the ZEBRA FISH(Danio rerio) .Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. The experimental phase of the main study started at 17-01-2017and lasted for a period of 96 hrs.
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material: N,N,N-tributylbutan-1-aminium hydrogen sulfate
- Molecular formula: C16 H36 N.H O4 S
- Molecular weight: 339.537 g/mol
- Smiles notation: C([N+](CCCC)(CCCC)CCCC)CCC.S([O-])(=O)(=O)O
- InChl: 1S/C16H36N.H2O4S/c1-5-9-13-17(14-10-6-2,15-11-7-3)16-12-8-4;1-5(2,3)4/h5-16H2,1-4H3;(H2,1,2,3,4)/q+1;/p-1
- Substance type: Organic
- Physical state: Solid
- Batch No./ Lot no.: L199101607
- Date of expiry: 01-06-21
- Purity: 100.03% (Assay by acidimetry)
- Stability: Stable in recommended storage conditions
- Storage Conditions: Ambient Temp (23 to 27 deg.C) (Keep container tightly closed in a dry & well ventilated place. Store in cool place. Do not expose to air, light & moisture.)
Analytical monitoring:
not specified
Vehicle:
no
Details on test solutions:
The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 100mg/L ,respectively.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name:ZEBRA FISH
- Source:UNIQUE AQUARIUM, NAGPUR
- Length at study initiation (length definition, mean, range and SD):1.53 cm
- Weight at study initiation (mean and range, SD):0.1523 g


ACCLIMATION
- Acclimation period:7 days
- Acclimation conditions (same as test or not):same
- Type and amount of food during acclimation:Standard brand feed
- Feeding frequency during acclimation:once daily
- Health during acclimation (any mortality observed):No mortality

QUARANTINE (wild caught)
- Duration:48 hrs
- Health/mortality:During last 48 hours = 0

FEEDING DURING TEST
- Food type:Standard brand feed
- Frequency:once daily
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
148.5 (mg of CaCO3)
Test temperature:
23 °C
pH:
6.91
Dissolved oxygen:
8.0 mg/l
Salinity:
No data
Conductivity:
No data
Nominal and measured concentrations:
100 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:The test vessels used were all plastic aquaria having the water capacity of 5liters.
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 2 liters
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter):


OTHER TEST CONDITIONS
- Photoperiod:16 hours light and 8 hours dark


TEST CONCENTRATIONS
- Test concentrations: 100 mg/l
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

Observation:

Mortality and symptoms

Nominal

Concentration

(mg/l)

Number of

fish

Mortality (cumulated) after

3 h

6 h

24h

48h

72h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

-

-

-

-

-

-

-

-

-

-

-

-

100

4

4

-

-

-

-

-

-

-

-

-

-

-

-

 

Visible Symptoms

Nominal

Concentration

(mg/l)

Number of

fish

Mortality (cumulated) after

3 h

6 h

24h

48h

72h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

100

4

4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

 

Explanation of symptoms:

A: apathy

N: Narcotic-like state

C: Swimming near water surface

M: Slow movements compared to control

NS: No abnormal symptoms

S: Surfacing behaviour

L: Loss of equilibrium

SM: Shimming movement

H1: Hyperactivity

H2: Hypo activity

B: Bending behavior

F: Fin rot

IS: Invert Swimming

SB: Swimming behaviour

RF: Respiratory Function

P: Pigmentation

Validity criteria fulfilled:
yes
Conclusions:
Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for CAS No.32503-27-8 on ZEBRA FISH(Danio rerio)was found to be >100 mg/L.
Executive summary:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for (test item name) Tetrabutylammonium hydrogen sulphate. The nominal concentration selected for the experiment was 100mg/Land test fish were exposed to this concentration for 96 hours. No mortality was observed at the end of the exposure. The lethal concentrations LC50 was determined to be >100 mg/L

LC0 (96 hours) (highest loading at which no mortality was observed) = 100 mg/L

LC50 (96 hours) Experimental = >100 mg/L

LC100 (96 hours) (lowest loading at which 100% mortality was observed) = No mortality was observed

Description of key information

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for (test item name) Tetrabutylammonium hydrogen sulphate. The nominal concentration selected for the experiment was 100mg/Land test fish were exposed to this concentration for 96 hours. No mortality was observed at the end of the exposure. The lethal concentrations LC50 was determined to be >100 mg/L

As no mortality was observed at highest loading thus LC0 (96 hours) was consider to be 100 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

The test chemical N,N,N-tributylbutan-1-aminium hydrogen sulfate (CAS no. 32503-27-8) and its relevant read across which is 80-90% structurally similar were reviewed to summarise the following information: 

An experiment was conducted by UERL (2017) to determine the toxic effects of the test compound chemical Tetrabutylammonium hydrogen sulphate (Cas no. 32503-27-8) on the ZEBRA FISH (Danio rerio).

According to study, Fish Acute Toxicity test according to OECD Guideline 203 was conducted for Tetrabutylammonium hydrogen sulphate.The nominal concentration selected for the experiment were 100mg/L and test fish were exposed to these concentration for 96 hours. The lethal concentrations LC50 was found to be >100 mg/L.

As no mortality was observed at highest loading thus LC0 (96 hours) was consider to be 100 mg/L.

Whereas the 96 hrs aquatic toxicity effect was predicted to assess toxic effects of the test compound N,N,N-tributylbutan-1-aminium hydrogen sulfate (CAS no. 32503-27-8) (QSAR toolbox ver.3.4, 2017). The study was based on the effects of the test compound on fish Oncorhynchus mykiss (previous name: Salmo gairdneri) in a static fresh water system. The predicted data suggests the lethal concentration (LC50) for the test compound was estimated to be 162.48 mg/l on the basis of mortality effect. Thus, based on this value, it can be concluded that the test chemical N,N,N-tributylbutan-1-aminium hydrogen sulfate can be considered as non toxic to fish and thus not consider for aquatic classification as per the CLP regulation.

Another prediction model ECOSAR v1.1; (2017) from EPI suite for target chemical N,N,N-tributylbutan-1-aminium hydrogen sulfate (CAS no. 32503-27-8) indicates that the lethal concentration (LC50) for the N,N,N-tributylbutan-1-aminium hydrogen sulfate(CAS no 32503-27-8) was estimated to be 2389.214 mg/L. Hence, N,N,N-tributylbutan-1-aminium hydrogen sulfate(CAS no 32503-27-8) was not considered being hazardous to fish and can be considered to be not classified as per the CLP regulation.

In addition, supporting experimental data (UERL laboratory result; 2013) for read across N,N,N-tributylbutan-1-aminium bromide (Cas no. 1643-19-2) indicated that 96 h study for tetrabutylammonium bromide on Poecilia reticulata, at a test concentration of 100 mg/L was conducted. The fishes were found to be lethargic yet swimming near the water surface. No mortalities were observed on 4 day (96 h) in the test concentration 100 mg/l. No mortalities were found in the control aquaria. Hence the LC50 was considered to be > 100 mg/L. Thus considering the CLP Criteria for aquatic classification of the substance, it is concluded that tetrabutylammonium bromide does not exhibit short term toxicity to fish. 

Thus, the study of read across chemical aupports the remaining study results of target. Hence, based on above studies, it can be concluded that the target chemical, N,N-tributylbutan-1-aminium hydrogen sulfate (CAS no. 32503-27-8) can be considered as non toxic to fish and thus not consider for aquatic classification as per the CLP regulation criteria.