4-morpholinopropanesulphonic acid

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:

2003-09-03 to 2003-12-04

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:

adopted July 17th 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

adopted July 31st 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Sampling was carried out at the start and end of study (0 and 96 h).

Vehicle:

no

Details on test solutions:

Good quality drinking water is used. The composition is analyzed yearly by the supplier.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Danio rerio
- Strain: Hamilton-Buchanan
- Source: weiler's pet's best, Neustadt, Germany
- Age at study initiation: sexually immature young fish
- Length at study initiation: 2 ± 1 cm

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as during the main study
- Amount of food during acclimation: 1 – 2 % body weight per day
- Feeding frequency during acclimation: 3 times/day

FEEDING DURING TEST
- Food type: No food was provided during the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

no specified

Test temperature:

23 ± 1 °C

pH:

6.7 - 8.6 (no adjustment)

Dissolved oxygen:

7.9 - 9.2 mg/L

Salinity:

not applicable

Conductivity:

not specified

Nominal and measured concentrations:

Nominal concentration: 1000 mg/L
Measured concentration: 106.26 % of the nominal concentration

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria, maximal volume 10 L
- Aeration: yes (with glass tubes; 1 bubble/sec)
- No. of organisms per vessel: 7 (main test); 3 (pre-test)
- No. of vessels per concentration: 1
- No. of vessels per control: 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12 hours using neon tubes

EFFECT PARAMETERS MEASURED: mortality and abnormal behaviour

TEST CONCENTRATIONS
- Range finding study: A range finding study (pre-test) was conducted.
- Test concentrations: 1000 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No test item related effects observed.
- Observations on body length and weight: none was observed
- Other biological observations: none was observed
- Mortality of control: No mortality was detected in the control.
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no

Sublethal observations / clinical signs:

VALIDITY

- The mortality in the control may not exceed 10 % at the end of the test. No mortalities occurred in the control.

 - The concentration of dissolved oxygen must be at least 60 % throughout the test. The concentration of dissolved oxygen stayed above 7.9 mg/L or 92 % throughout the test (100 % at 101300 Pa equals 8.57 mg/L, following DIN 38408 part 22).

ANALYTICAL DETERMINATIONS

The analytical determinations of the test item in the test solution showed good recovery after 96 hours. The recovery of more than 100 % was probably caused by evaporation effects. Therefore the test item can be considered as stable under the test conditions.

RESULTS

Parameter	Value	95 % confidence-interval
24 - 96 h LC0	1000 mg/L	n.a.
24 - 96 h LC50	> 1000 mg/L	n.a.
24 - 96 h LC100	>> 1000 mg/L	n.a.

Validity criteria fulfilled:

yes

Conclusions:

The 96 h LC50 was determined to be > 1000 mg/L and 96 h LC0 was determined to be 1000 mg/L.

Executive summary:

The objective of the study was to evaluate the acute toxicity of the test item on Zebrafish (Danio rerio) according to OECD TG 203 under GLP conditions. For this purpose, young fish were exposed to aqueous test media containing the test item for 96 h. Based on results obtained in a preliminary experiment fish were exposed to a single nominal concentration of 1000 mg/L (limit test). The test medium served as the negative control. A static test was performed as the test item was previously shown to be stable in the test medium over the test period. The analytical determinations of the test item in the test solution showed good recovery after 96 hours. The recovery of more than 100 % was probably caused by evaporation effects. Thus, the test item can be considered as stable under the test conditions. The nominal concentration was used to estimate the result. The 96 h LC₅₀ for the test item was determined to be > 1000 mg/L and 96 h LC₀ was determined to be 1000 mg/L.

Description of key information

The 96 h LC₅₀ was determined to be > 1000 mg/L (reference 6.1.1-1).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 000 mg/L

Additional information

The objective of the study was to evaluate the acute toxicity of the test item on Zebrafish (Danio rerio) according to OECD TG 203 under GLP conditions. For this purpose, young fish were exposed to aqueous test media containing the test item for 96 h. Based on results obtained in a preliminary experiment fish were exposed to a single nominal concentration of 1000 mg/L (limit test). The test medium served as the negative control. A static test was performed as the test item was previously shown to be stable in the test medium over the test period. The analytical determinations of the test item in the test solution showed good recovery after 96 hours. The recovery of more than 100 % was probably caused by evaporation effects. Thus, the test item can be considered as stable under the test conditions. The nominal concentration was used to estimate the result. The 96 h LC₅₀ for the test item was determined to be > 1000 mg/L and 96 h LC₀ was determined to be 1000 mg/L.