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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17-19 March 1999 and 4-6 May 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

(1984) - referenced as Method C.2 of Commission Directive 69/92/EEC

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Each test sample was diluted with acetonitrile : trifluoroacetic acid (100:0.2 v/v) to give a final theoretical test material concentration of 50 mg/l.
Standard solutions of test material were prepared in acetonitrile : water : trifluoroacetic acid (50:50:0.1 v/v/v) at a nominal concentration of 50 mg/l.

Vehicle:

no

Details on test solutions:

For the purpose of the definitive study, the test material was prepared by direct solution in water with the aid of ultrasonication. 100 mg of test material were dissolved in reconstituted wated with the aid of ultrasonication for approximately 1 minute and the volume adjusted to 1 litre to give the 100 mg/l test concentration. The concentration and stability of the test material in the test solutions were verified by chemical analysis at 0 and 48 hours.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna were maintained in a laboratory culture originating from a strain supplied by the Institut National de Recherche Chimique Appliquee (IRCHA), France.
Adult Daphnia were maintained in polypropylene vessels containing approximately 2 litres of reconstituted water in a temperature controlled room at 21 C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a suspension of mixed algae (predominantly Chlorella spp.) Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated 24 hours prior to the initiation of the test, the young daphnids produced overnight were then removed for testing. The diet and diluent were considered not to contain any contaminant that would affect the integrity or outcome of the study.

Test type:

static

Water media type:

freshwater

Remarks:

the reconstituted water used for both the range-finding and definitive studies was the same as that used to maintain the stock animals

Limit test:

yes

Total exposure duration:

48 h

Remarks on exposure duration:

As required by the Guideline

Post exposure observation period:

Not mentioned

Hardness:

CA 250 mg CaCO3/L

Test temperature:

21 C

pH:

6.3 at 0 hours
6.8-6.9 at 48 hours

Dissolved oxygen:

8.3 mg O2/l at 0 hours
8.0-8.1 mg O2/l at 48 hours

Salinity:

not mentioned

Conductivity:

not mentioned

Nominal and measured concentrations:

Range-finding study: Daphnia magna were exposed to nominal concentrations of 1.0, 10 and 100 mg/l.
Definitive study: a single test concentration of four replicates, of 100 mg/l
Analysis of the test preparations at 0 and 48 hours showed the measured test concentrations to be near nominal and so it was considered justifiable to estimate the EC50 values in terms of the nominal test concentrations only.

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Details on results:

%Concentration loss over test: 0 ...

Results with reference substance (positive control):

Not relevant

Reported statistics and error estimates:

Not mentioned

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated and gave a 48-hour EC50 of greater than 100 mg/l. Correspondingly the No Observed Effect Concentration was 100 mg/l

Executive summary:

Methods

A study was performed to assess the acute toxicity of the test material to Daphnia magna. The method followed that described in the OECD Guidelines for Testing of Chemicals (1984) No 202, "Daphnia sp, Acute Immobilisation Test and Reproduction Test" referenced as Method C.2 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Procedures

Following a preliminary range-finding study, forty daphnids (4 replictes of 10 animals) were exposed to an aqueous solution of the test material at a concentration of 100 mg/l for 48 hours under static test conditions. Immobilisation and any adverse reactions to exposure were recorded after 24 and 48 hours.

Results

The 48-hour EC50 for the test material to Daphnia magna based on nominal test concentrations was greater than 100 mg/l and correspondingly the No Observed Effect Concentration 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 and 48 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 acute toxicity of the test material to Daphnia magna. The method followed that described in the OECD Guidelines for Testing of Chemicals (1984) No 202, "Daphnia sp, Acute Immobilisation Test and Reproduction Test" referenced as Method C.2 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The 48-hour EC50 for the test material to Daphnia magna based on nominal test concentrations was greater than 100 mg/l and correspondingly the No Observed Effect Concentration 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 and 48 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 invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L