Bis(2-methoxyethyl) ether

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:

supporting study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: DIN 38412, L15

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was directly applied to the experimental basin
- Eluate: tap water
- Differential loading: 1000 - 2000 mg/L
- Controls: tap water without test item tested under the same consitions as the test groups

Test organisms (species):

Leuciscus idus

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no

Hardness:

Dechlorinated tap water: total hardness 17°d, carbonate hardness 9°d

Test temperature:

20.0 °C

pH:

8.2 - 8.5

Dissolved oxygen:

7.5 - 8.3 mg/L

Salinity:

Freshwater

Nominal and measured concentrations:

Please refer to "any other information on materials and methods"

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 2 000 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

2 000 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: None
- Mortality of control: 0%
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None

Sublethal observations / clinical signs:

No moratlity was observed in the 96 -hour study. No adverse effects were seen in the in-life phase of this study. Fish were sectioned at the end of the study and no visible changes wera apparent.

Validity criteria fulfilled:

yes

Conclusions:

The acute LC0 and LC50 for golden orfe is > 2000 mg/L under these conditions.

Executive summary:

The acute LC0 and LC50 for golden orfe is > 2000 mg/L under these conditions.

This non-key information supports the read across justification that triglyme can be used as analogue to diglyme, because they share the same toxic mode of action so that read across among each other can be used to assess the acute aquatic toxicity of the individual members.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

read across justification for the endpoint short-term toxicity to fish. See attached document under 13.2

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

reference to same study

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Details on results:

The analytically determined concentration of the test item Triethyleneglycoldimethylether in the test medium varied in the range from 105 to 113% of the nominal values. Thus, the correct dosing of the test item was confirmed. Furthermore, it has been demonstrated that the test item
Triethyleneglycoldimethylether was stable under the conditions of the test during the test period of 96 hours. Therefore, all reported biological
results are related to the nominal concentration of the test item.

In the control and the test medium with the nominal concentration of 5000 mg/L all fish survived until the end of the test and no visible
abnormalities were observed at the test fish. Therefore, the 96 hour NOEC and LC0 of Triethyleneglycoldimethylether to zebra fish were both
determined to be at least 5000 mg/L. The 96 hour NOEC and LC0 might even be higher than this concentration, but concentrations in excess of
5000 mg/L have not been tested, in agreement with the guidelines. The 96 hour LOEC, LC50 and LC100 were clearly higher than 5000 mg/L. These values could not be quantified due to the absence of toxicity of Triethyleneglycoldimethylether at the tested concentration.

No remarkable observations were made concerning the appearance of the test medium. It was a clear solution throughout the entire test duration.
The pH values in the control and the test item treatment ranged from 7.3 to 7.4. The oxygen concentration was always 8.4 mg/L or higher , and thus higher than 60% oxygen saturation. The water temperature was 21 22 °C during the test.

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

not required since no effect was observed

Validity criteria fulfilled:

yes

Executive summary:

Under 13.2 attached is the justification for read across to existing data from triethylene glycol dimethyl ether (Triglyme, CAS 112-49-2) as an appropriate source molecule. It is hypothesized that triglyme can be used as analogue to diglyme, because they share the same toxic mode of action so that read across among each other can be used to assess the acute aquatic toxicity of the individual members.The appropriateness of the chosen source molecule is based on structural and functional similarities, comparable physicochemical properties, common metabolic pathway(s), and a similar mode of action indicating a comparable ecotoxicological profile for diglyme as the target substance and triglyme as the source substance.

The read across key-study from Triglyme with Danio rerio and the supporting information from diglyme in Leuciscus idus are available for acute toxicity to fish. The most reliable LC50 determined was > 5000 mg/L.

A summary of the key study with Triglyme is given below:

The acute toxicity of the test item Triethyleneglycoldimethylether to zebra fish (Brachydanio rerio) was determined in a 96-hour static test according to the EU Commission Directive 92/69/EEC, Part C.1 Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992).

 A limit test was performed in accordance with the guidelines to demonstrate that the test item has no toxic effect on the test organisms at the nominal concentration of 5000 mg/L. Thus, the only nominal concentration tested was 5000 mg/L. Additionally, a control was tested in parallel.

 The analytically determined concentration of the test item Triethyleneglycoldimethylether in the test medium varied in the range from 105 to 113% of the nominal values. Thus, the correct dosing of the test item was confirmed. Furthermore, it has been demonstrated that the test item Triethyleneglycoldimethylether was stable under the conditions of the test during the test period of 96 hours. Therefore, all reported biological results are related to the nominal concentration of the test item.

 In the control and at the test concentration of 5000 mg/L no mortality or other visible abnormalities were determined at the test fish during the test period of 96 hours.

Therefore, the 96-hour NOEC and the 96-hour LC₀of Triethyleneglycoldimethylether to zebra fish were determined to be at least 5000 mg/L. These values might even be higher but nominal concentrations in excess of 5000 mg/L were not tested, in accordance with the test guidelines. The 96‑hour LOEC, the 96‑hour LC₅₀and the 96‑hour LC₁₀₀were clearly higher than 5000 mg/L. These values could not be quantified due to the absence of toxicity of Triethyleneglycoldimethylether at the tested concentration.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-Dec-2009 to 22-Dec-2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No 440/2008, Part C.1, 30 May 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

swissmedic: Date of inspection: 05 to 09-Nov-2007 and 26 to 30-Nov-2007; Date of decision: 2008-04-30, Date of signature: 12-Nov-2008

Analytical monitoring:

yes

Details on sampling:

For the determination of the actual test item concentrations, duplicate samples were taken from each treatment before the start of the test, after 48
hours and at the end of the test after 96 hours.
All samples were taken from the approximate center of the aquaria without mixing of the test medium. Immediately after sampling, methanol
(10 mL per 10 mL sample) was added to each sample to stabilize the latter during the storage period. Thereafter, all samples were stored at about
-20 °C.

Vehicle:

no

Details on test solutions:

At the start of the test, the test medium of nominal 5000 mg/L was freshly prepared by completely dissolving 20.004 g of the test item in four liter
of test water under intense stirring for 15 minutes at room temperature. The test medium was freshly prepared just before introduction of the fish
(= start of the exposure).

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The study was performed with zebra fish (Brachydanio rerio). The fish were obtained from a breeding culture at Harlan Laboratories. No medication
was applied during holding and acclimatization. Prior to test start, the test fish were acclimated for one week to the test water and temperature.
During holding and acclimatization until one day before the start of the test, the fish were fed with a commercial fish diet (Tetra Min® Hauptfutter,
supplied by TETRA-Werke, 49304 Melle / Germany). During holding and acclimatization, no fish died in the test fish batch and all fish were healthy.

From the acclimated test fish batch, 10 fish were measured at the start of the test. The mean body length of the fish was 3.0 ± 0.17 cm (Mean ± SD),
the mean body wet weight was 0.22 ± 0.03 g (Mean ± SD).

The test method and test species are recommended by the international test guidelines.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

not applicable

Hardness:

Water Hardness : 1.25 mmol/L or 125mg/L as CaCO3

Test temperature:

The water temperature was 21-22 °C during the test

pH:

The pH values in the control and the test item treatment ranged from 7.3 to 7.4

Dissolved oxygen:

The oxygen concentration was always 8.4 mg/L or higher and thus higher than 60% oxygen saturation

Salinity:

according to OECD medium

Nominal and measured concentrations:

A single test item concentration of nominal 5000 mg/L was tested. The recoveries were 105% (day 0), 111% (day 2) and 113% (day 4) of the nominal
concentration.

Details on test conditions:

Reconstituted test water was used in the study. It consisted of analytical grade salts dissolved in purified water to obtain the following nominal
concentrations:

Ingredients / Propertie│Concentration

CaCl2 × 2H2O │1.0 mmol/L - 147 mg/L
MgSO4 × 7H2O│0.25mmol/L - 61.5 mg/L
NaHCO3│0.38mmol/L - 32.5 mg/L
KCl│0.038mmol/L - 2.9 mg/L
Water Hardness│1.25mmol/L - 125 as CaCO3 mg/L
Alkalinity│0.4mmol/L ---


The ratio of Ca:Mg and Na:K was 4:1 and 10:1, respectively, based on molarity. The test water was aerated prior to the preparation of the test medium until oxygen saturation was reached.

One glass test vessel with 4 liters of test medium was used for each treatment. The test vessels were labeled with the study number and all
necessary additional information to ensure unique identification. The water temperature in the test vessels was maintained at 21-22 °C . The test
vessels were slightly aerated during the test period.

A 16 hour light to 8-hour dark photoperiod, with a 30-minute transition period was used (light intensity during the light period was approximately
within the range of 100 to 480 Lux). The test duration was 96 hours and the fish were not fed during the test.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 5 000 mg/L

Nominal / measured:

nominal

Conc. based on:

other: test item

Basis for effect:

mortality (fish)

Details on results:

The analytically determined concentration of the test item Triethyleneglycoldimethylether in the test medium varied in the range from 105 to 113% of the nominal values. Thus, the correct dosing of the test item was confirmed. Furthermore, it has been demonstrated that the test item
Triethyleneglycoldimethylether was stable under the conditions of the test during the test period of 96 hours. Therefore, all reported biological
results are related to the nominal concentration of the test item.

In the control and the test medium with the nominal concentration of 5000 mg/L all fish survived until the end of the test and no visible
abnormalities were observed at the test fish. Therefore, the 96 hour NOEC and LC0 of Triethyleneglycoldimethylether to zebra fish were both
determined to be at least 5000 mg/L. The 96 hour NOEC and LC0 might even be higher than this concentration, but concentrations in excess of
5000 mg/L have not been tested, in agreement with the guidelines. The 96 hour LOEC, LC50 and LC100 were clearly higher than 5000 mg/L. These values could not be quantified due to the absence of toxicity of Triethyleneglycoldimethylether at the tested concentration.

No remarkable observations were made concerning the appearance of the test medium. It was a clear solution throughout the entire test duration.
The pH values in the control and the test item treatment ranged from 7.3 to 7.4. The oxygen concentration was always 8.4 mg/L or higher , and thus higher than 60% oxygen saturation. The water temperature was 21 22 °C during the test.

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

not required since no effect was observed

Validity criteria fulfilled:

yes

Executive summary:

The acute toxicity of the test item Triethyleneglycoldimethylether to zebra fish (Brachydanio rerio) was determined in a 96-hour static test according to the EU Commission Directive 92/69/EEC, Part C.1 Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992).

 

A limit test was performed in accordance with the guidelines to demonstrate that the test item has no toxic effect on the test organisms at the nominal concentration of 5000 mg/L. Thus, the only nominal concentration tested was 5000 mg/L. Additionally, a control was tested in parallel.

 

The analytically determined concentration of the test item Triethyleneglycoldimethylether in the test medium varied in the range from 105 to 113% of the nominal values. Thus, the correct dosing of the test item was confirmed. Furthermore, it has been demonstrated that the test item Triethyleneglycoldimethylether was stable under the conditions of the test during the test period of 96 hours. Therefore, all reported biological results are related to the nominal concentration of the test item.

 

In the control and at the test concentration of 5000 mg/L no mortality or other visible abnormalities were determined at the test fish during the test period of 96 hours.

Therefore, the 96-hour NOEC and the 96-hour LC₀of Triethyleneglycoldimethylether to zebra fish were determined to be at least 5000 mg/L. These values might even be higher but nominal concentrations in excess of 5000 mg/L were not tested, in accordance with the test guidelines. The 96‑hour LOEC, the 96‑hour LC₅₀and the 96‑hour LC₁₀₀were clearly higher than 5000 mg/L. These values could not be quantified due to the absence of toxicity of Triethyleneglycoldimethylether at the tested concentration.

Description of key information

From Read across source substance Triglyme: LC50, Danio rerio: > 5000 mg/L
Supporting study from diglyme: NOEC, Leuciscus idus: 2000 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

5 000 mg/L

Additional information

Under 13.2 attached is the justification for read across to existing data from triethylene glycol dimethyl ether (Triglyme, CAS 112-49-2) as an appropriate source molecule. It is hypothesized that triglyme can be used as analogue to diglyme, because they share the same toxic mode of action so that read across among each other can be used to assess the acute aquatic toxicity of the individual members.The appropriateness of the chosen source molecule is based on structural and functional similarities, comparable physicochemical properties, common metabolic pathway(s), and a similar mode of action indicating a comparable ecotoxicological profile for diglyme as the target substance and triglyme as the source substance.

The read across key-study from Triglyme with Danio rerio and the supporting information from diglyme in Leuciscus idus are available for acute toxicity to fish. The most reliable LC50 determined was > 5000 mg/L.