Dimethyl adipate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

This IUCLID for dimethyl adipate is compiled using data from the substance itself, a structurally related compound (dimethyl glutarate) and a mixture of dibasic esters (dimethyl adipate, succinate and glutarate). The toxicity of each of these substances is similar and the document attached justifies why data on the category members can be used to support the data gaps for dimethyl adipate.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 797.1400 (Fish Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

The test material was prepared as a 0.1 mL/mL solution in acetone

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

Common name: Bluegill sunfish
4.7 centimeters standard length

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

Not determined

Test temperature:

20±0.2°C

pH:

Concentration (ppm) pH Initial pH Final
50 7.3 7
40 7.2 6.5
37.5 7.3 6.4
35 7.1 6.6
32.5 7.3 6.4
30 7.2 6.6
27.5 7.3 6.5
25 7.3 6.7
20 7.2 6.7
Control 7.4 6.8
Acetone Control 7 6.7

Dissolved oxygen:

Concentration (ppm) Initial Final
50 8.2 6.5
40 8.1 1.2
37.5 8.1 1.5
35 8.2 0.8
32.5 8.2 1.3
30 8.2 0.6
27.5 8.2 1.3
25 8.2 1.5
20 8.1 1.5
Control 8.2 3.8
Acetone Control 8.1 1.7

Details on test conditions:

TEST SYSTEM
- Test vessel: All-glass 15L vessesls
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Glass, 15 Liter fill
- Aeration: no
- Type of flow-through (e.g. peristatic or proportional diluter): NA
- Renewal rate of test solution (frequency/flow rate): NA
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality was determined every 24 hours for 96 hours. Dead fish were removed as discovered.

Reference substance (positive control):

no

Duration:

96

Dose descriptor:

LC50

Effect conc.:

30.9 other: ppm (v/v)

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: undefined

Details on results:

Concentration (ppm) Mortality (%)
50 100
40 100
37.5 100
35 90
32.5 40
30 80
27.5 10
25 10
20 20
Control 0
Acetone Control 0

Reported statistics and error estimates:

Calculation of the 96 hour LC50 and confidence limits was by probit analysis (Finney 1952)
Dose-response slope 20.88 wtih 95% CL of -4.27 and 46.03

Validity criteria fulfilled:

yes

Conclusions:

LC50 is 30.9 based on probit analysis. Substance exhibits a very steep does-response and high variablity of reponse at concentrations tested. By
observation, the 96-hour LC-50 falls between 27.5 and 37.5 ppm.

Executive summary:

The test material, as a 0.1 ml/ml solution in acetone, was introduced into all-glass vessels which contained 10 bluegill sunfish (4.7 cm) in 15 L of water. . Fish were not fed 48 hours prior or during exposure. No aeration was provided and temperature was maintained at 20±0.2°C. Dissolved oxygen and pH measuments were taken at exposure intiation and end. Mortality counts and observation were made every 24 hours for a total of 96 hours after intitiating exposure. Dead fish were removed at the time of discovery. Calculation of the 96 hour LC50 and confidence limits was by probit analysis (Finney 1952).

No definitive signs of toxicity were reported. An LC50 of 30.9 ppm was determined. Substance exhibits a very steep does-response and high variablity of response at concentrations tested. By observation, the 96-hour LC-50 falls between 27.5 and 37.5 ppm.

Summary: Dimethyl glutarate exhibits moderate acute toxicity to bluegill sunfish under static unaerated conditions. The LC50 is 30.9 ppm with 95% confidence limits undefined. A dose-response slope of 20.88 wtih 95% CL of -4.27 and 46.03 was determined.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1982-04-02 to 1982-04-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

This IUCLID for dimethyl adipate is compiled using data from the substance itself, a structurally related compound (dimethyl glutarate) and a mixture of dibasic esters (dimethyl adipate, succinate and glutarate). The toxicity of each of these substances is similar and the document attached justifies why data on the category members can be used to support the data gaps for dimethyl adipate.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OTS 797.1400 (Fish Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The test material, in original form and prepared as a stock solution was introduced into all-glass exposure vessels and diluted with laboratory-aged well water to yield the desired exposure concentrations in 10 L final volumes. An identical vessel, containing only laboratory supply water, was designated as the control.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Length at study initiation: 1.8 cm
- Weight at study initiation: 0.07 g wet weight
- Feeding during test: Fish were not fed for 48 hours prior to exposure

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

EDTA Hardness: 123 mg/L as CaCO3 at 0 h

Test temperature:

22 °C

pH:

0 h 7.8, control 7.7
24 h 7.6
48 h 7.4
96 h 7.7, control 7.8
Total Alkalinity: 119 mg/L as CaCO3 at 0 h

Dissolved oxygen:

0 h 8.5 to 8.6 mg/L
(Dissolved oxygen should be between 8.0 to 8.9 mg/L in the dilution water for tests with fathead minnow according to EPA OTS 797.1400)
24 h 7.5 mg/L
48 h 7.2 to 7.4 mg/L, control 6.8 mg/L
96 h 6.8 mg/L, control 7.1 mg/L

Salinity:

Conductivity: 126 umhos (= micro ohms per cm or decisiemens per m [dS/m])

Nominal and measured concentrations:

nominal 0, 10, 13, 18, 24, 32, 42, 56, 75, 100 ppm (v/v)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: all-glass exposure vessel, 10 L final volume
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
The pH was measured at the beginning and end of exposure in the control and low test concentration. Dissolved oxygen and pH were measured in the medium test concentration at the beginning and at 48 hours after the exposure was initiated. Dissolved oxygen and pH were measured in the high test concentration at the beginning and at 24 hours after the test was initiated. The total alkalinity, hardness (EDTA) and conductivity of the control were measured at the beginning of the exposure in the control.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: maintained at 16 hour light: 8 hours dark

EFFECT PARAMETERS MEASURED:
Mortality counts and observations were made every 24 hours during the 96 hours exposure period. Dead fish were removed as they were discovered.

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 18 - < 24 other: ppm (v/v)

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No no mass based concentrations or density given in the study report

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

18 other: ppm (v/v)

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No no mass based concentrations or density given in the study report

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

24 other: ppm (v/v)

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks:

70%

Remarks on result:

other: No no mass based concentrations or density given in the study report

Details on results:

Percent mortalities for Fathead minnows exposed to the test item, DBE, are presented in Table I.

Sublethal observations / clinical signs:

Table I

Nominal concentration [mg/L]	Observed Mortality [%]
	24 h	48 h	72 h	96 h
100	100	100	100	100
75	100	100	100	100
56	100	100	100	100
42	100	100	100	100
32	90	100	100	100
24	50	70	70	70
18	0	10	10	10
13	0	0	0	0
10	0	0	0	10
Control	0	0	0	0

 

Validity criteria fulfilled:

yes

Remarks:

EPA OTS 797.1400 were met

Conclusions:

The 96-hour LC50 of DBE to fish was estimated to be greater than 18 ppm (v/v) but less than 24 ppm (v/v) in laboratory supply water.

Executive summary:

Fathead minnows (Pimephales promelas) were exposed to Dibasic esters (DBE) with the test medium. No mass based concentrations or density is given in the study report. No GLP statement is made. The protocol applied is comparable to and fulfils the criteria of EPA OTS 797.1400 (Fish Acute Toxicity Test) for a valid result. The study is conclusive since the density of the test item is considered not different from standard material.

The test animals were exposed to nominal concentration of 0, 10, 13, 18, 24, 32, 42, 56, 75, and 100 ppm (v/v). No analytical measurements of the tested concentrations was performed but due to the high solubility of the substance it is expected to be stable during the test.

No mortality was observed in the control. The temperature, pH and the oxygen in the medium were maintained in the range recommended by the guidance document. DBE exhibited moderate acute toxicity to fathead minnows under static, unaerated test conditions during a 96-hour exposure. The 96-hour LC₅₀ ranges between the NOEC of 18 ppm (v/v) and the LOEC of 24 ppm (v/v), where 70% mortality was observed.

Description of key information

The 96-hour LC50 of DBE to fish was estimated to be greater than 18 ppm (v/v) but less than 24 ppm (v/v) in laboratory supply water.

Additional information

Justification for Read Across

Attached at section 13 is a category justification that explains the rationale for using data on a mixture of Dimethyl Esters (DBE), and Dimethyl Glutarate, to supplement the available data on Dimethyl Adipate.

One reliable key study is available for this endpoint. In this study (Phillips FX, 1982), fathead minnows (Pimephales promelas) were exposed to Dibasic esters (DBE) with the test medium. No mass based concentrations or density is given in the study report. No GLP statement is made. The protocol applied is comparable to and fulfils the criteria of EPA OTS 797.1400 (Fish Acute Toxicity Test) for a valid result. The study is conclusive since the density of the test item is considered not different from standard material.

The test animals were exposed to nominal concentration of 0, 10, 13, 18, 24, 32, 42, 56, 75, and 100 ppm (v/v). No analytical measurements of the tested concentrations was performed but due to the high solubility of the substance it is expected to be stable during the test.

No mortality was observed in the control. The temperature, pH and the oxygen in the medium were maintained in the range recommended by the guidance document. DBE exhibited moderate acute toxicity to fathead minnows under static, unaerated test conditions during a 96-hour exposure. The 96-hour LC₅₀ranges between the NOEC of 18 ppm (v/v) and the LOEC of 24 ppm (v/v), where 70% mortality was observed.