Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

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:
05/2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
This study was carried out in accordance with OECD guideline no. 202. This study was also carried out in accordance with GLP standards with the exception of the analytical measurement of test concentrations, which was carried out at a non-GLP facility.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
Test solution concentrations were only measured at the highest and lowest nominal concentrations, but these were shown to be within 20% of the nominal concentrations so this should be deemed acceptable.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Samples of the lowest and highest test concentrations were taken at test initiation (0 hours) and test termination (48 hours) and were stored in darkness until analysis.
Vehicle:
no
Details on test solutions:
Test solutions were prepared on the day of test initiation by adding 400 mg of the test substance to 400 ml of aerated M7-media and stirring for 10 minutes. The solution was then membrane filtered (0.45 µm) and used as stock solution. The nominal concentration of the stock solution was 580 mg/L of test substance. Test concentrations were made by dilution of the stock solution with aerated M7-media.
Test organisms (species):
Daphnia magna
Details on test organisms:
Newly hatched Daphnia magna between 6 and 24 hours old were used in this test. Test organisms were taken from Toxicon's continuous culture of Daphnia magna. Cultures were fed with the green algae Pseudokirchneriella subcapitata.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No information provided
Hardness:
250 ± 25 mg/L CaCO3
Test temperature:
21.5 ± 1°C
pH:
7.8 ± 0.2
Dissolved oxygen:
97-105% saturation
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentrations: 25, 50, 100, 200 and 400 mg/L.
Measured concentrations were within ± 20% of the nominal concentrations.
Details on test conditions:
See methods below
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
290 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The 48-hour EC50 was found to be 290 mg/L for 2-Oxepanone, polymer with 1,4-butanediol. The 48-hour NOEC was observed to be 100 mg/L.
Results with reference substance (positive control):
No information provided.
Reported statistics and error estimates:
No information provided.

Table 1: Nominal NOEC and EC50 values (mg/L) determined after 24 and 48 hours exposure to the test item 2-Oxepanone, polymer with 1,4-butanediol

24 h NOEC (mg/L)   48 h NOEC (mg/L)  24 h EC50 (mg/L) 48 h EC50 (mg/L) 
 100  100  330 290

Table 2: Results of TOC determination of saturated 2-Oxepanone, polymer with 1,4-butanediol solutions and the measured concentrations in test solutions.

 Nominal test concentration  TOC (mg/L)  Capa 2043 concentration (mg/L) Nominal value ± 20%
 25 mg/L (0 h) 15 24.6  20-30
 25 mg/L (48 h) 16 26.2 20-30
 400 mg/L (0 h) 230 377  320-480
 400 mg/L (48 h) 240 393  320-480
Validity criteria fulfilled:
yes
Conclusions:
With a 48-hour EC50 of 290 mg/L and a 48-hour NOEC of 100 mg/L, 2-Oxepanone, polymer with 1,4-butanediol can be regarded as non-toxic to Daphnia magna according to 67/548/EEC (KIFS 2005:7) and EC no 1272/2008 (CLP).
Executive summary:

A 48-hour toxicity test was carried out to determine the acute toxicity of 2-Oxepanone, polymer with 1,4-butanediol to Daphnia magna. The study was carried aout according to OECD guideline no. 202. Test solutions were created by diluting a stock solution of the test substance in M7 media. Test organisms were incubated in glass petri dishes with 25 ml solution at 21.5 ± 1°C. Four replicates were used for both test and control solutions, with five test organisms in each.

The pH and oxygen saturation were measured at test initiation and test termination. Observations for immobilisation were made at 24 and 48 hours. Analytical measurements were not made at a GLP compliant facility and were only made at the lowest and highest concentrations. Although this can be considered a limitation in this study, it is not considered to have adversely affected the results as indications from the analysis were that test concentrations had remained within 20% of the nominal concentrations.

The results showed that the 48-hour EC50 was 290 mg/L, while the 48-hour NOEC was found to be 100 mg/L. An EC50 of greater than 100 mg/L indicates that 2-Oxepanone, polymer with 1,4-butanediol can be regarded as non-toxic to Daphnia magna according to 67/548/EEC (KIFS 2005:7) and EC no 1272/2008 (CLP).

Description of key information

The key study for acute toxicity of 2-Oxepanone, polymer with 1,4-butanediol to aquatic invertebrates found a 48-hour EC50 of 290 mg/L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
290 mg/L

Additional information

A 48-hour toxicity test was carried out to determine the acute toxicity of 2-Oxepanone, polymer with 1,4-butanediol to Daphnia magna. The study was carried out according to OECD guideline no. 202. Test solutions were created by diluting a stock solution of the test substance in M7 media. Test organisms were incubated in glass petri dishes with 25 ml solution at 21.5 ± 1°C. Four replicates were used for both test and control solutions, with five test organisms in each.

The pH and oxygen saturation were measured at test initiation and test termination. Observations for immobilisation were made at 24 and 48 hours. Analytical measurements were not made at a GLP compliant facility and were only made at the lowest and highest concentrations. Although this can be considered a limitation in this study, it is not considered to have adversely affected the results as indications from the analysis were that test concentrations had remained within 20% of the nominal concentrations.

The results showed that the 48-hour EC50 was 290 mg/L, while the 48-hour NOEC was found to be 100 mg/L. An EC50 of greater than 100 mg/L indicates that 2-Oxepanone, polymer with 1,4-butanediol can be regarded as non-toxic to Daphnia magna according to 67/548/EEC (KIFS 2005:7) and EC no 1272/2008 (CLP).