Carbonic acid, ethyl methyl ester

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: official guideline method, GLP with certificate, good documentation, identity of substance clear but no details on its purity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-480-9

EC Name:

-

Cas Number:

623-53-0

Molecular formula:

C4H8O3

IUPAC Name:

ethyl methyl carbonate

Details on test material:

Test material as stated in study report ("Sponsor's identification"): MEC
Description: clear colourless liquid
Batch number: 00925
Date received: 11.27.2000
Storage conditions: stored at room temperature in the dark until 01.16.2001, thereafter stored at 4 °C, in the dark

Remark of the author of this IUCLID dossier concerning the substance identity:
Every page of the copy of the study report contains an annotation referring to the data sharing agreement in place between the licensee that uses this study report and the data owner. In this data sharing agreement the identity of the chemical substance is specified with "Ethyl Methyl Carbonate - EC No. 433-480-9, CAS Nr. 623-53-0".

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Details on test solutions:

200 mg of test material was dissolved in culture medium and the volume adjusted to give 1 litre (stock solution 200 mg/L). The stock solution was mixed with 1 litre of algal suspension to give 100 mg/L test concentration.

Test organisms

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Details on test organisms:

Strain: CCAP 276/20
obtained from: Culture Collection of Algae and Protozoa (CCAP), Institute of Freshwater Ecology, The Ferry House, Far Sawrey, Ambleside, Cumbria

Study design

Test type:

static

Water media type:

freshwater

Total exposure duration:

72 h

Test conditions

Test temperature:

24 +/- 1 °C

pH:

7.5 (at 0 h) to 10.1 (at 72 h), increase of pH due to assimilation of CO2 derived from bicarbonate in solution

Details on test conditions:

test was conducted in 250 mL glass conical flasks under constant illumination (intensity approximately 7000 lux) and shaking (approximately 100 rpm) at a temperature of 24 +/- 1 °C

Results and discussion

Effect concentrations

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 62 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

cell number

Details on results:

The results of both range-finding studies showed no adverse effect on growth at the test concentrations of 1.0, 10 and 100 mg/L. Indeed algal growth increased relative to the control cultures at the higher test concentrations. Based on this information a single test concentration of six replicates, of 100 mg/L was selected for the definitive study. No adverse effect on growth was observed.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Range-finding study results: EC50 > 100 mg/L and NOEC = 100 mg/L; algae growth promoted by test substance.
Definitive study results: Based on the time-weighted mean measured test concentrations the EC50 values were estimated to be greater than 62 mg/L. Correspondingly the No Observed Effect Concentration was 62 mg/L (EbC50 (72 h) > 62 mg/L; ErC50 (0-72 h) > 62 mg/L)

Based on these test results it is suggested that no classification is required according to REGULATION (EC) No 1272/2008 (of 16 Dec 2008).