Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07-Dec-2009 to 22-Dec-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. Conclusive valid guideline study under GLP conditions.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008, Part C.1, 30 May 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Identity: Triethyleneglycoldimethylether
CASNo.: 112-49-2
Purity: 99.8% (by GC)

Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not applicable

Sampling and analysis

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.

Test solutions

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

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.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
not applicable

Test conditions

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

Results and discussion

Effect concentrationsopen allclose all
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
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
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
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
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

Applicant's summary and conclusion

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.