N-(2-carboxyethyl)-N-octyl-β-alanine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP, quality criteria met. limit test, lack of details on substance identity. no analytical measurement of test concentration.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not relevant

Analytical monitoring:

no

Details on sampling:

Not relevant

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was dispersed directly in test water to give a stock solution of 2000 mg a.i./l. The desired exposure level was obtained by adjusting 1 litre of this stock with test water to a final volume of 20 litres.
- Controls: Yes, blanks

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Westacre trout farm, Norfolk, UK
- Age at study initiation (mean and range, SD):
- Length at study termination (controls): 5.3 +/- 0.9 cm
- Weight at study termination (controls): 2.33 +/- 0.96 g
- Feeding during test: no feeding during the test, starting 24h prior to test


ACCLIMATION
- Acclimation period: 3 months
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial trout pellets
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no mortality in the week prior to the start of the experiment

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Not relevant

Hardness:

154 mg/l CaCO3

Test temperature:

14 - 15ºC

pH:

7.7 - 8.0

Dissolved oxygen:

8.98 - 10.00 mg/l

Salinity:

Not relevant

Nominal and measured concentrations:

Nominal: 100 mg a.i./l

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Material, size, headspace, fill volume: glass, containing 20 litres of test medium
- Aeration: None
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1- Biomass loading rate: 1.16 g/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water filtered, dechlorinated and passed through an Elga water purification system. The water passed in sequence through a high-pressure sand filter to remove colloids and particulate matter and a high grade activated carbon filter to remove chlorine and any organic contaminants. A proportion of the supply the passes through a water softener before final reverse osmosis treatment to produce a highly purified water supply. The two grades of dechlorinated water are the remixed in the ratio of approximately 1:1 to give a supply with the desired water hardness.
- Conductivity: 1000 uS/cm
- Chlorine: below limit of detection
- Culture medium different from test medium: No
- Intervals of water quality measurement: 24 hours

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16/8 hour light/dark photoperiod

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and sublethal effects (observed daily)

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

Not relevant

Reported statistics and error estimates:

No data

Sublethal observations / clinical signs:

For detailed results, see attached file "Results.docx".

Validity criteria fulfilled:

yes

Remarks:

Mortality in controls 0%, abiotic conditions within limits

Conclusions:

The acute toxicity (96h-LC50) of test item towards Oncorhynchys mykiss is > 100 mg a.i./l.

Executive summary:

The acute toxicity of the test item towards Oncorhynchys mykiss was investigated according to OECD Guideline 203 under GLP. Fish were exposed to a concentration 100 mg a.i./ for 96 hours. The 96h-NOEC and 96h-LC50 were found to be > 100 mg a.i./l.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

See read-across justification attached in Section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Description of key information

An analogue test material gave LC50 (96 h) > 100 mg a.i./L based on mortality of Oncorhynchys mykiss (OECD 203).

Additional information

The acute toxicity of an analogue test item towards Oncorhynchys mykiss was investigated according to OECD Guideline 203 under GLP. Fish were exposed to a concentration 100 mg a.i./ for 96 hours. The 96h-NOEC and 96h-LC50 were found to be > 100 mg a.i./L.