Bis(2-(2-butoxyethoxy)ethyl) 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:

guideline study with acceptable restrictions

Remarks:

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

Table 2: Validity criteria for OECD 203.

Criterion from the guideline	Outcome	Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test	0%	yes
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value throughout the test	Not indicted in test report.
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20%, results should be based on the measured concentration.	No analytical monitoring performed

 

Validity criteria fulfilled:

not specified

Remarks:

See "Any other information on results incl. tables"

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

10 March 1998 to 14 March 1998

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests methods were stated to be based on methods of the OECD (1992) and the U.S. EPA (1993) and to follow the appropriate GLP requirements for these. No characterization of the test material was provided. Test concentrations (water accommodated fractions) were nominal.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

yes (Not all fish were within the prescribed lengths, this was not considered to have affected the outcome of the study)

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 797.1400 (Fish Acute Toxicity Test)

Deviations:

yes

Remarks:

yes (See previous)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Range-finding test
Initially conducted at 2 WAF concentrations (100 and 1000 mg/L). An additional vessel with a nominal 10 mg/L WAF was prepared.

Definitive test
WAF test solutions were prepared by dilutions of a nominal 1000 mg/L. The stock was prepared by combining 22 g of the test substance with 22 liters
of dilution water in mixing vessels with magnetic stirrers. The mixtures were stirred for 24 hours and allowed to settle for approximately 1 hour. Water for dilutions was obtained by syphoning.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Mount Lassen Trout Farm, Red Bluff, CA (24 February 1998)
- Age at study initiation (mean and range, SD): not given
- Length at study initiation (length definition, mean, range and SD): not given
- Weight at study initiation (mean and range, SD): not given
- Feeding during test: fish were not fed during the test or for the 48 hours immediately prior to the test.
- Food type: Tetra Min Staple Food, Lot #TM07
- Amount: not stated
- Frequency: daily

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Feeding frequency: daily
- Health during acclimation (any mortality observed): yes, mortality was less than 3% during the final 48 hours

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

none

Hardness:

The hardness and alkalinity of the dilution water used to initiate the definitive toxicity test was 44 mg/L as CaCO3 and 35 mg/L as CaCO3, respectively.

Test temperature:

12 +/- 1 deg C

pH:

pH values ranged from 7.0 to 7.8 during the definitive test

Dissolved oxygen:

values ranged from 7.6 to 10.4 mg/L during the definitive test

Salinity:

no measured

Nominal and measured concentrations:

Range-finding test
10, 100 and 1000 mg/L (nominal, WAF)

Definitive test
0, 13, 22, 36, 60 and 100 mg/L (nominal, WAF)

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 liter
- Type: open
- Material: glass
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized, obtained from Marblehead, MA
- Total organic carbon: none detected (nd)
- Particulate matter: not given
- Metals: none detected
- Pesticides: none detected
- Chlorine: none detected
- Conductivity: ranged from 150 - 170 micromhos/cm during definitive test
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hour light / 8 hour dark (15 minute transition period)
- Light intensity: fluorescent, 17 microEin/m^2-sec

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

27 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test mat. (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% interval: 22 to 36 mg/L

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

22 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test mat. (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% interval: 13 to 36 mg/L

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

21 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test mat. (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% interval: 13 to 36 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

21 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test mat. (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% interval: 13 to 36 mg/L

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

13 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test mat. (WAF)

Basis for effect:

mortality (fish)

Details on results:

Refer to Table 1

Sublethal observations / clinical signs:

Table 1: Survival and sublethal effects
Nominal Concentration (mg/L, WAF)	Replicate	Live trout (affected trout)
		0 hr	3 hr	6hr	24hr	48hr	72hr	96hr
0 (control)	1	10	10	10	10	10	10	10
	2	10	10	10	10	10	10	10
13	1	10	10	10	10	10	10	10
	2	10	10	10	10	10	10	10
22	1	10	10	10	10 (1*)	10	8	8
	2	10	10	10	9 (3*)	0	0	0
36	1	10	10	10 (1*)	0	0
	2	10	10	10 (2*)	0	0
60	1	10	10 (7*)	0	0	0
	2	10	10 (4*)	0	0	0
100	1	10	0	0	0	0
	2	10	0	0	0	0
* - affected fish were dark in color and exhibited loss of equilibrium

Validity criteria fulfilled:

not specified

Executive summary:

The WAF of the test substance was toxic to rainbow trout in the range of nominal test concentrations employed. The 96 -hour median lethal concentration (LC50) was 21 mg/L. The 96 -hour NOEC was 13 mg/L.

Description of key information

LC50 (96 h): 13 mg/L (nominal) for Oncorhynchus mykiss (OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

13 mg/L

Additional information

One study is available on the short-term toxicity of Bis(2-(2-butoxyethoxy)ethyl) adipate (CAS 141-17-3) to fish.

This key study was performed according to OECD Guideline 203 (Sewell, 1992). The test organism Oncorhynchus mykiss was exposed to nominal concentrations of 10, 18, 32, 56 and 100 mg/L for 96 hours. Mortality occurred at all test concentrations except the lowest, and a LC50 of 13 mg/L (nominal) was calculated.