Choline chloride

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:

1988-05-02 - 1988-05-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The experiment was conducted equivalent to the national guideline (DIN 38412), meeting scientific principles. No information about GLP compliance is reported. Not all details are described in test report; however, available data indicate that the study was well-performed.

Qualifier:

equivalent or similar to guideline

Guideline:

other: DIN 38412

GLP compliance:

not specified

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material: No surrogate or analogue material was used.

Analytical monitoring:

no

Details on sampling:

Samples were taken after 1, 4, 24, 48, 72 and 96 h.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test substance was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, Hohenwestedt, Germany
- Length at study initiation: 7.8 cm (range: 6.6 - 9.1)
- Weight at study initiation: 4.7 g (range: 3.1 - 6.7)
- Corpulence factor of the batch: 1.0 (determined 1988-03-28)

HOUSING AND ADAPTION
- The fish were kept in a flow-through tank in tap water cleaned by active carbon and aerated with oil-free air.
- Photoperiod: 16 h light and 8 h dark
- Total hardness: about 2.5 mmol/L
- Acid capacity: about 5.5 mmol/L
- Oxygen content > 60 % of maximum saturation
- pH: about 8.0
- Duration: about 6 months
- Adaption to test water and test temperature: 3 days
- Water temperature: 11 - 20 °C
- Mortality during the last 2 weeks of housing: about 0.6 %
- Mortality during the adaption period: 0 %
- Medical treatment: Thrice with 0.05 mg/L malachite green chloride and once with 10 mg/L tetracycline hydrochloride
- Diet: Growing feed F/B 50, SSNIFF Spezialdiaeten GmbH, Soest, Germany
- Withdrawal of food: 1 day before and during exposure

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

No post exposure observation period described.

Hardness:

2.5 mmol/L

Test temperature:

21 °C

pH:

Control: 7.3 - 7.9
5000 mg/L: 7.6 - 7.7
10000 mg/L: 7.8 - 7.9

Dissolved oxygen:

Control: 7.4 - 8.0 mgO2/L
5000 mg/L: 7.5 - 7.8 mgO2/L
10000 mg/L: 8.0 - 8.4 mgO2/L

Salinity:

Not applicable.

Nominal and measured concentrations:

5000 and 10000 mg/L
The concentration exceeded the normal upper limit for acute studies in fish because it was the aim to test higher concentrations for classification of hazards to water (German WGK - Wassergefährdungsklassen).

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquarium
- Material, size, fill volume: glass, 30 x 22 x 24 cm, 10 L
- Aeration: slight, continuous with oil-free air
- No. of organisms per vessel: 10
- Biomass loading rate: 4.7 g/L

TEST MEDIUM / WATER PARAMETERS
- Preparation: Reconstituted freshwater according to DIN 38412, Part 11, October 1982.
- Resalting: Addition of 294 mg/L CaCl2 x 2 H2O, 123.3 mg/L MgSO4 x 7 H2O, 63 mg/L NaHCO3, 5.5 mg/L KCl
- Conductivity: max. 10 µMHO
- Acid capacity: 0.8 mmol/L
- Ratio Ca/Mg ions: 4:1
- Ratio Na/K ions: 10:1
- pH: about 8

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

RANGE FINDING STUDY
- Results used to determine the conditions for the definitive study: LC50(96h) > 10000 mg/L

Reference substance (positive control):

yes

Remarks:

Chloroacetamide

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 1 % Significance level

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Neither any symptoms nor any mortality occurred during the exposure duration.

Results with reference substance (positive control):

LC50(48h): ~ 32 mg/L (Determined: 1988-04-18)

Reported statistics and error estimates:

Determination / calculation of the median lethal concentration (LC50) and, if possible, the LC5 and LC95 was performed by Probit Analysis after 1, 4, 24, 48, 72 and 96 hours.
Reference: Finney, D.J., Probit Analysis, Cambr. Univ. Press, 3rd Ed., 1971. Certain aspects of this method have been modified (Details: Internal SOP).

Validity criteria fulfilled:

yes

Remarks:

Scientific criteria for acute toxicity testing to fish seemed to be fulfilled.

Conclusions:

The study report describes a valid study, conducted equivalent to a national guideline (DIN 38412). No information about GLP compliance available. Available data confirm that the experiment was well-performed. The test substance was not toxic to fish up to a concentration of 10000 mg/L during an exposure duration of 96 h.

Executive summary:

Choline chloride (with an active ingredient content of 78 %) was tested for its toxicity towards the freshwater fish Leuciscus idus (Golden orfe) with an exposure time of 96 hours (BASF AG, 1988). The experiment was conducted equivalent to the German guideline DIN 38412. After a range-finding study (LC50(96h) > 10000 mg/L), two concentration were fixed as followed: 5000 mg/L and 10000 mg/L. The concentrations exceeded the normal upper limit for acute studies because it was the aim to test higher concentrations for classification of hazards to water. The test substance was added to the test water without any pretreatment, based on its easily solubility. Chloroacetamide served as positive control, resulting in a LC50(48h) of about 32 mg/L. This lethal concentration corresponds to the normal sensitivity. The test temperature was set at 21 °C and the pH was around 8. 10 animals per concentration were used, a control was also included. Thus, the biomass loading rate was 4.7 g/L. Probit analysis was used as statistical method. Neither any abnormalities nor mortality was recorded during the experiment. The LC50(96h) can be considered to be > 10000 mg/L and the NOEC(96h): 10000 mg/L.

Description of key information

No toxicity observed even at highest concentration level tested.
Leuciscus idus_DIN 38412: LC50(96h) > 10000 mg/L, NOEC(96h): 10000 mg/L (applies for 78 % and 50 % Choline Chloride)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

10 000 mg/L

Additional information

Choline chloride (with an active ingredient content of 78 %) was tested for its toxicity towards the freshwater fish Leuciscus idus (Golden orfe) with an exposure time of 96 hours (BASF AG, 1988). The experiment was conducted equivalent to the national guideline DIN 38412. After a range-finding study (LC50(96h) > 10000 mg/L), two concentrations were fixed as followed: 5000 mg/L and 10000 mg/L. The concentrations exceeded the normal upper limit for acute studies because it was the aim to test higher concentrations for classification of hazards to water. The test substance was added to the test water without any pretreatment, based on its easily solubility. Chloroacetamide served as positive control, resulting in a LC50(48h) of about 32 mg/L. This lethal concentration corresponds to the normal sensitivity. The test temperature was set at 21 °C and the pH was around 8. 10 animals per concentration were used, a control was also included. Thus, the biomass loading rate was 4.7 g/L. Probit analysis was used as statistical method. Neither any abnormalities nor mortality was recorded during the experiment. The LC50(96h) can be considered to be > 10000 mg/L and the NOEC(96h): 10000 mg/L.

The same results are reported in an experiment conducted under identical conditions with 50 % Choline chloride (BASF AG, 1988).