ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol

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:

15-19 June 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: na
- Purity: Mixture of polymers
- Water solubility: about 750 mg/L

Analytical monitoring:

yes

Details on sampling:

Duplicate samples were taken from each freshly prepared saturated solution for Total Organic Carbon (TOC) analysis. In addition samples were taken from the three highest test concentrations for qualitative HPLC analysis of freshly prepared and aged test medium.

Vehicle:

no

Details on test solutions:

A saturated solution was prepared by adding 3.5 g of CAPA-304 to 3.5 L of ISO-water followed by stirring for 10 minutes with an Ultra-Turrax blender. The resulting turbid emulsion was filtered through a 0.45 um nylon membrane filter and produced a clear solution. Dilutions of this solution were made by taking 100, 750, 375, 187, 95 and 48 mL to 3 l with ISO-water. This procedure was repeated every 24 hours to prepare the new test solutions.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish, Brachydanio rerio.
- Source: Commercial supplier - Ruinemans, Montfoort, The Netherlands
- Length at study initiation: 2.2- 3.1 cm
- Weight at study initiation: 0.3 g


ACCLIMATION
- Acclimation period: From 20 May 1992 until start of the study, 15 June 1992


FEEDING DURING TEST - fish were not fed

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

About 250 mg CaCO3/L

Test temperature:

22.2 - 24.0 °C

pH:

7.5 - 7.9

Dissolved oxygen:

6.8 - 8.4 mg/L

Salinity:

Not applicable

Conductivity:

Not reported

Nominal and measured concentrations:

Nominal test concentrations were 0 (control), 12, 23, 47, 94, 188 and 375 mg/L.

Analysis of the TOC samples, diluted 1:1 with ISO-water provided a mean measured concentration of 760 mg/L after correction for the ca. 60% C-content of the test usbstance. Based on this concentration the exposure levels were calculated to be 12, 24, 48, 95, 190 and 380 mg Capa-304/L.

The results of the study were based on the nominal concentrations.

HPLC chromatograms were compared for the fresh 1/8 x saturated solution and after 24 hours, this qualitative examination indicated that the fish were exposed to a constant mixture of Capa-304 components.

Details on test conditions:

TEST SYSTEM
- Test vessel: not stated
- Type: open
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates):1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO water -


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light / 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects every 24 hours

TEST CONCENTRATIONS
- Range finding study; yes (with Poecilia reticulata), 100% mortality to saturated solution and no mortality with a 10% dilution
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

performed yearly in the laboratory

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

190 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

47 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

behaviour

Details on results:

The results of the study were based on nominal exposure concentrations. The 96 hour LC50 was calculated to be 190 mg/L (based on the dissolved fraction of CAPA-304 components).

Sub-lethal effects were seen in the 188 mg/L treatment from 48 hours until the end of the exposure period - all surviving fish showed uncontrolled movement. In the 94 mg/L treatment sub-lethal effects were seen in 1 or 2 fish after 72 and 96 hours respectively.

Results with reference substance (positive control):

Performed annually by the laboratory using potassium bichromate. The reported value for a test conducted in April 1992 was 142 mg/L.

Reported statistics and error estimates:

Probit analysis using a proprietary statistics program, SAS for the LC50 and Fisher's exact test for the NOEC.

Sublethal observations / clinical signs:

Analytical results

Sampling date	TOC of 1:1 dilution (mg/L)	Capa-304 (mg/L)*	Mean (mg/)
15 June 1992	230	736
16 June 1992	250	800	760
17 June 1992	230	736
18 June 1992	240	768

 * calculated as follows: TOC result of 1:1 diltion multiplied by 2 (dilution factor), and multiplied by 1.6 (Capa-304 C content approximately 60%)

Mortality results

 

Nominal conc. (mg/L)	Mortality				% mortality at 96 hours
	24 hours	48 hours	72 hours	96 hours
0	0	0	0	0	0
12	0	0	0	0	0
23	0	0	0	0	0
47	0	0	0	0	0
94	0	0	0	0	0
188	0	6	6	6	60
375	0	10	10	10	100

 

Validity criteria fulfilled:

yes

Conclusions:

The 96 hour LC50 of Capa-304 to Zebra fish was calculated to be 190 mg/l based on nominal exposure concentrations.

Executive summary:

The acute toxicity of Capa-304 to Zebra fish was determined. The study was carried out according to OECD test guideline 203 - Acute Toxicity for Fish. In this study Zebra fish were exposed to Capa-304 over a test period of 96 hours under semi-static conditions with test media renewal every 24 hours. A saturated test medium was prepared by the addition of Capa-304 to water followed by 10 minutes of stirring, the resultant medium was filtered through a 0.45 µm filter and the resultant test solution was diluted to prepare the test media.  Total Organic Carbon (TOC) analysis was performed on each freshly prepared saturated test medium batch; in addition a qualitative HPLC analysis was performed on the aqueous filtrate. Nominal exposure concentrations were 0 (control), 12, 23, 47, 94, 188 and 375 mg/l. The qualitative HPLC review demonstrated that were exposed to a constant mixture of CAPA-304 components. Based on the TOC results the exposure levels were calculated to be 12, 24, 48, 95, 190 and 380 mg/l. The results of the study were based on the nominal concentrations.

 

The 96 hour LC50 of Capa-304 to Zebra fish was 190 mg/l (nominal concentration). 

Description of key information

A reliable (Klimisch 2) study with freshwater fish, Danio rerio (previously known as Brachydanio rerio) and using the test substance, ε-Caprolactone, oligomeric reaction products with 2,2’-oxydiethanol, is available. The 96 hour LC50 (mortality) was calculated to be 190 mg/l based on Total Organic Carbon (TOC) analysis. This value is taken as the short-term toxicity in fish endpoint for e-Caprolactone-DEG.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

190 mg/L

Additional information

The acute toxicity of Capa-304 to Zebra fish, Danio rerio (previously known as Brachydanio rerio) was determined. The study was carried out according to OECD test guideline 203 - Acute Toxicity for Fish. In this study fish were exposed to Capa-304 over a test period of 96 hours under semi-static conditions with test media renewal every 24 hours. A saturated test medium was prepared by the addition of Capa-304 to water followed by 10 minutes of stirring, the resultant medium was filtered through a 0.45 µm filter and the resultant test solution was diluted to prepare the test media.  Total Organic Carbon (TOC) analysis was performed on each freshly prepared saturated test medium batch; in addition a qualitative HPLC analysis was performed on the aqueous filtrate. Nominal exposure concentrations were Control (0), 12, 23, 47, 94, 188 and 375 mg/L. The qualitative HPLC review demonstrated fish that were exposed to a constant mixture of CAPA-304 components. Based on the TOC results the exposure levels were calculated to be 12, 24, 48, 95, 190 and 380 mg/L. The results of the study were based on the nominal concentrations.

 

The 96 hour LC50 of Capa-304 to Zebra fish was calculated to be 190 mg/l (nominal concentration).