Reaction mass of diisobutyl adipate and diisobutyl glutarate and diisobutyl succinate

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

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:

Marine fish species used

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
None

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 1.6 mg/L WAF loading rate
- Sampling method: Samples were collected at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) for analysis
- Sample storage conditions before analysis: Duplicate samples stored at -20 degrees Celsius for furhter analysis if necessary.

Vehicle:

no

Details on test solutions:

The 1.6 mg/L loading rate WAF was prepared by adding 33.6 mg of test material to the surface of 21 litres of synthetic sea water. This was stirred for 23 hours and then allowed to stand for 1 hour. A wide bore glass tube covered at one end with Nescofilm was then submerged in the vessel, sealed end down, to a depth of approximately 5cm from the bottom. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. The aqueous phase of the WAF was then removed by mid-depth syphoning (the firs 75 -100ml discarded). Microscopic inspection of the WAF showed no microdispersions or undissolved test material to be present.

Test organisms (species):

other: Scophthalmus maximus (juvenile turbot)

Details on test organisms:

Fish (Scopthalmus maximus) supplied by Viking Fish Farms Ltd, Ardtoe Marine laboratory (UK) were maintained in a glass tank with an activated carbon recirculation filter system. They were acclimatised to test conditions for 12 days. The lighting cycle was 16 hours of light and 8 hours of darkness with a 20 minute dawn/dusk transition. Water temperature was controlled at 14 degrees Celcius with a dissolved O2 content of greater than or equal to 8.0 mg/L (recorded daily).

The fish were fed commercial turbot pellets until 24 hours before the start of the test. There was no mortality during the acclimatisation period in the 7 days prior to the test. Fish length and weight were 5.1cm (SD 0.2) and 3.65g (SD0.35) respectively. The loading rate was therefore 1.3g bodyweight per litre.

Test type:

semi-static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

no data

Test temperature:

13-14 degrees Celsius

pH:

7.9-8.7

Dissolved oxygen:

7.5-8.7

Salinity:

31 o/oo

Nominal and measured concentrations:

Nominal: 1.6 mg/L loading rate water-accommodated fraction (WAF).

Chemical analysis of the fresh media at 0 and 72 hours showed measured concentrations of 0.391 and 1.23 mg/L, respectively. Analysis of the old media at 24 and 96 hours showed measured concentrations to be less than the limit of quantitation of 0.052 mg/L. The decline in measured concentrations was in line with stability analysis conducted over a 24-hour period. However, given that the test material was prepared as a WAF and that toxicity cannot be attributed to a single component or a mixture of components but to the test material as a whole, the results were based on nominal loading rates.

Details on test conditions:

In the definitive study, 20 L glass vessels were used for the control and test concentration. 7 fish were allocated at random to each vessel. The vessels were covered to reduce evaporation and maintained at a temperature of 14 degrees Celcius in a room with a 16/8 h light dark cycle for a period of 96 hours. Aeration of test vessels was acheived using a narrow bore glass tube inserted into each vessel. Fish were not fed during the study.

The test preparations were renewed daily (semi static) to ensure the test material remained near the nominal level and to prevent build up of nitrogenous waste products. Mortalities and sub lethal effects were recorded at 3, 6, 24, 48, 72 and 96 hours. Death was considered to be the absence of both respiratory movement and response to physical stimulation. Water temperature, pH and dissolved O2 were recorded daily.

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.6 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Nominal WAF Loading Rate

Basis for effect:

other: mortality and sublethal effects

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1.6 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Nominal WAF Loading Rate

Basis for effect:

mortality (fish)

Details on results:

During the study there were no mortalities and no sub-lethal effects.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

The 23 hour mixing period for preparation of the WAF was considered sufficient and thus used in the preparation of the definitive test concentrations.

During the study there were no mortalities and no sub-lethal effects.

Validity criteria fulfilled:

yes

Conclusions:

The LL50 for the test material was greater than 1.6 mg/L WAF.

Executive summary:

A study was performed to assess the acute toxicity of COASOL to juvenile turbot (Scophthalmus maximus). The method followed OECD Test Guideline No. 203, EC Method C.1, and OSLO Paris Commission (OSPARCOM) Guidelines 1995.

 

Following an acute toxicity to Acartia tonsat est and marine algal inhibition test for the same test material, which showed the lowest EC50 values to be 1.6 mg/L loading rate water-accommodated fraction (WAF), a single group of seven fish were exposed to WAFs of the test material at a single nominal loading rate of 1.6 mg/L for a period of 96 hours at a temperature of ~14°C under semi-static (daily renewal) conditions.

 

Chemical analysis of the fresh media at 0 and 72 hours showed measured concentrations of 0.391 and 1.23 mg/L, respectively. Analysis of the old media at 24 and 96 hours showed measured concentrations to be less than the limit of quantitation of 0.052 mg/L. The decline in measured concentrations was in line with stability analysis conducted over a 24-hour period. However, given that the test material was prepared as a WAF and that toxicity cannot be attributed to a single component or a mixture of components but to the test material as a whole, the results were based on nominal loading rates.

 

The 96-hour LL50 was greater than 1.6 mg/L and correspondingly, the NOELR was 1.6 mg/L.

Description of key information

A short-term marine water fish toxicity test with juvenile turbot (Scopthalmus maximus) exposed to COASOL and conducted under GLPs, semi-static conditions and following standard test guidelines (OECD 203) resulted in both a 96-hour LL50 value of >1.6 mg/L.

Key value for chemical safety assessment

Marine water fish

Marine water fish

Effect concentration:

1.6 mg/L

Additional information

One short-term marine fish study was available for COASOL and considered reliable for assessment of this endpoint. The study was conducted with the juvenile turbot (Scopthalmus maximus) and found to be of good quality and assigned a Klimisch score of 1. Due to the low water solubility of the test substance, fish were exposed to the water-ammodated fraction resulting from a solution prepared at a nominal loading rate of 1.6 mg/L. The study was conducted for 96-hours, under semi-static conditions, following OECD Test Guideline 203, and under GLPs. No fish mortality or sublethal effects were observed during the exposure and the study concluded the 96-hour LL50 value was >1.6 mg/L and considered the key parameter for this endpoint.