Reaction mass of bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl]adipate and 2-[2-(2-butoxyethoxy)ethoxy]ethyl (3,6,9,12-tetraoxahexadecyl)adipate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 - 11 Sept 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions: Analytical purity not stated. Water hardness is lower as recommended in current guidelines. Dissolved oxygen and pH are not stated.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Water hardness lower as recommended in guideline.

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was directly added to the dilution water with the aid of stirring for approximately 30 min.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Parkwood Trout Farm, Kent, UK
- Length at study initiation (length definition, mean, range and SD): 4.9 ± 0.3 cm
- Weight at study initiation (mean and range, SD): 1.51 ± 0.26 g
- Feeding during test: none

ACCLIMATION
- Acclimation period: 7 days before start of test
- Type and amount of food: not stated
- Health during acclimation (any mortality observed): No mortality was observed in the 7 days prior to the start of the study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

~ 50 mg/L as CaCO3

Test temperature:

14 °C

pH:

not stated

Dissolved oxygen:

not stated

Nominal and measured concentrations:

Nominal: 10, 18, 32, 56 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquaria
- Size: 20 L
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: 0.76 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Intervals of water quality measurement: not stated

EFFECT PARAMETERS MEASURED: Mortality was observed after 3, 6, 24, 48, 72 and 96 h test duration.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed at 10 mg/L and 100% mortality was observed at 100 mg/L. Additionally, the preliminary range finding study showed that at the required test concentrations a good dispersion of the test substance in water could be achieved.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 10 - 18 mg/L

Details on results:

- Behavioural abnormalities: The only marked reactions to exposure (other than death) was loss of equilibrium at 56 mg/L (3/7 fish at 3 h) and 32 mg/L (1/3 fish at 6 h) and the presence of moribund fish at 56 mg/L (4/7 fish at 3 h) and 32 mg/L (2/3 fish at 6 h).

Sublethal observations / clinical signs:

Table 1: Cumulative mortality of rainbow trout to the test substance (96 h)

Nominal concentration [mg/L]	Cumulative mortality (initial population = 10)
	3 h	6 h	24 h	48 h	72 h	96 h
control	0	0	0	0	0	0
10	0	0	0	0	0	0
18	0	0	10	10	10	10
32	0	7	10	10	10	10
56	3	10	10	10	10	10
100	10	10	10	10	10	10

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance.

Adequacy of study:

key study

Justification for type of information:

Please refer to the analogue justification attached to chapter 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 10 - 18 mg/L

Remarks:

Source, RA-A, CAS 141-17-3

Description of key information

LC50 (96 h)= 13 mg/L (nominal, OECD 203); Read across

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

13 mg/L

Additional information

Data on the acute toxicity of the target substance (EC 943-330-9) to fish are not available. The assessment was therefore based on a study conducted with the analogue substance Bis[2-(2-butoxyethoxy)ethyl] adipate (CAS 141-17-3) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Further justification is given within the overall summary chapter 6.1 and within the analogue justification in IUCLID section 13.

The acute toxicity of the source substance Bis[2-(2-butoxyethoxy)ethyl] adipate (CAS 141-17-3) to fish was tested in a guideline study following OECD 203. Fish of the speciesOncorhynchus mykisswere exposed to nominal substance concentrations of 10, 18, 32, 56 and 100 mg/L for 96 h. A semi-static test system was set up with a daily renewal of the test solutions. The test solutions were prepared by direct dispersion of the substance in water and subsequent stirring for approx. 30 min. At concentrations of 56 mg/L and 32 mg/L loss of equilibrium and moribund fish were observed. The lowest concentration resulting in 0% mortality was 10 mg/L. Thus, a NOEC of 10 mg/L (nominal) was reported. The determined LC50 (96 h) was 13 mg/L.