L-Valine, N-(methoxycarbonyl)-3-methyl-

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:

6-10 September 1999

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:

(1992) - Referenced as EU method C.1 in Directive 92/69/EEC

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

An aliquot of each sample was diluted with water : acetonitrile : trifluoroacetic acid (20:80:0.2 v/v) to a final theoretical test material concentration of 50 mg/l.
Standard solutions of materials were prepared in mobile phase at a nominal concentration of 50 mg/l. The range of standard solutions was prepared in water : acetonitrile : trifluoroacetic acid (30:70:0.1 v/v) covering 0 to approximately 200% of the working concentration.
The limit of quantitation was assessed down to 2.1 mg/l.
A pre-study test sample was prepared in a bottle and analysed initially and then after storage at ambient temperature in light and dark conditions for approximately 24 hours (equivalent to the period of media renewal). The test samples have been shown to be sufficiently stable for the purposes of the study.

Vehicle:

no

Details on test solutions:

Test material (4000 mg) was directly dissolved in dechlorinated tap water with the aid of ultrasonication for approximately 25 minutes.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The test was carried out using juvenile rainbow trout (Oncorhynchis mykiss). Fish were obtained from Brow Well Fisheries, Hebden, Yorkshire, UK and were maintained in-house since 3 August 1999. Fish were maintained in a glass fibre tank with a "single pass" water renewal system.
The stock fish were fed commercial trout pellets which was discontinued 24 hours prior to the start of the definitive study. There were no mortalities in the 7 days prior to the start of the test and the fish had a mean standard length of 4.5 cm (s.d. = 0.2) and a mean weight of 1.13 g (s.d. = 0.20) at the end of the definitive study. Based on the mean weight value, this gave a loading rate of 0.57 g body weight / litre (static volume).
The diet and diluent water are considered not to contain any contaminant that would affect the integrity and outcome of the study.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

As specified in guidelines.

Post exposure observation period:

Not mentioned

Hardness:

100 mg CaCO3/L

Test temperature:

14 C

pH:

7.6 - 8.0

Dissolved oxygen:

9.4 mg O2/l

Salinity:

not mentioned

Conductivity:

not mentioned

Nominal and measured concentrations:

range-finding test: 10 and 100 mg/l
"Limit test": 100 mg/l

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Details on results:

There were no mortalities in 14 fish exposed to a test concentration of 100 mg/l for a period of 96 hours. Inspection of the mortality data showed the highest test concentration resulting in 0% mortality to be greater than or equal to 100 mg/l, the lowest test concentration resulting in 100% mortality to be greater than 100 mg/l and the No Observed Effect Concentration (NOEC) to be 100 mg/l. The NOEC is based upon zero mortalities and the absence of any sub-lethat effects of exposure at this concentration.

There were no sub-lethal effects observed in 14 fish exposed to a test concentration of 100 mg/l for a period of 96 hours.

Results with reference substance (positive control):

Not relevant

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour LC50 for the test material to rainbow trout (Oncorhynchus mykiss), based on nominal test concentrations was greater than 100 mg/l and correspondingly the NOEC was 100 mg/l.

Executive summary:

Methods

A study was performed to assess the acutr toxicity of the test material to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1. of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Procedures

Following a preliminary range-finding study fish were exposed, in two groups of seven to an aqueous solution of the test material, at a single concentration of 100 mg/l for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination after 96 hours.

Results

The 96-hour LC50 for the test material to rainbow trout (Oncorhynchus mykiss), based on nominal test concentrations was greater than 100 mg/l and correspondingly the NOEC was 100 mg/l. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/l. Analysis of the test solutions at 0, 24 and 96 hours showed the measured test concentrations to be near nominal and so the results are based on nominal test concentrations only.

Description of key information

A study was performed to assess the acutr toxicity of the test material to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1. of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The 96-hour LC50 for the test material to rainbow trout (Oncorhynchus mykiss), based on nominal test concentrations was greater than 100 mg/l and correspondingly the NOEC was 100 mg/l. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/l. Analysis of the test solutions at 0, 24 and 96 hours showed the measured test concentrations to be near nominal and so the results are based on nominal test concentrations only.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L