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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-11-21 to 2017-03-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)
Remarks:
2017-01-10
Analytical monitoring:
yes
Details on sampling:
Duplicate samples for analysis were taken from the control and the test concentration of 100 mg.L-1 at the start and at the end of the test (t=48h).
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The mixing vessel was a cylindrical glass bottle sealed with a screw cap and fitted with a drain port near the bottom for drawing off the stock solution. The volume of the mixing vessel was approximately 1 L. A magnetic stirring bar was placed in the vessel and test water (2.2.) was added. Then 100 mg of the test item (actual measured amount: 110 mg) were weighed on a weighing boat that afterwards was placed above the mixing vessel and rinsed with test water. The mixing vessel was then carefully filled with the remaining volume of test water to obtain 1 L of stock solution at 100 mg.L-1 and thereafter was closed immediately. The mixing was initiated with the vortex in the centre extending maximally around 10% vessel depth from the top to the bottom of the vessel. The stirring speed was as low as possible to maintain mixing of the water phase without dispersing the test substance in the water phase. After 23 hours of gentle stirring, the content of the vessel was allowed to stand undisturbed for at least 1 hour before use. The first 100 mL were removed via the drain port, and then the stock solution was directly added into test tubes (without headspace) that were immediately sealed with screw caps after introduction of daphnids. No small bubble was observed in the test tubes. The test solution was observed to be clear and colourless. The test was carried out without adjustment of the pH.

- Controls: Test water without test substance but treated in the same way as the test substance solutions.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Strain: Daphnia magna (Straus), clone 5
- Source: LIEBE - CNRS UMR 7146 - UFR SciFA - Université de Lorraine Campus Bridoux - Bât. IBISE, 8, rue du Général Delestraint - 57070 METZ, bred in the Laboratoires des Pyrénées et des Landes.
- Reason for selection: Characteristic and common representative of freshwater zooplankton which has been selected as an internationally accepted invertebrate species.
- Daphnids originated from a healthy stock, showing no signs of stress such as mortality, presence of males, ephippia or discoloured animals.
- Age at study initiation: < 24 h
- Breeding Conditions: Daphnids were cultured in the Laboratoires des Pyrénées et des Landes under similar temperature and light conditions as used in the test. The cultivation of the parental daphnids was performed in allglass vessel containing test water. Cultures were maintained at a density of 1 adult daphnid per 25 mL of culture medium. Daphnids were fed at least three times a week with a suspension of algal cells (Pseudokirchneriella subcapitata) up to 0.1-0.2 mg C.Daphnia.-1day.-1. The water was changed at least once per week. These culture conditions maintained the daphnids in the parthenogenetic reproductive stage.
- Feeding during test: No feeding
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Remarks on exposure duration:
None
Post exposure observation period:
None
Hardness:
Total water hardness was approximately 250 mg/L (as CaCO3)
Test temperature:
between 20.6 and 20.9 °C throughout the test (average value: 20.8°C), and complied with the requirements (20°C ± 2°C, constant within 1°C).
pH:
8.05 to 8.44
pH requirements: 6.0-9.0, not varying by more than 1.5 units
Dissolved oxygen:
7.40 (corresponding to a value > 85% of the air-saturation value) to 8.27 mg O2/L
oxygen: ≥ 60% of the air-saturation value at the end of the test in controls and test vessels.
Salinity:
None
Nominal and measured concentrations:
Nominal : 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: All-glass test tubes of approximately 20 mL capacity sealed with screw caps. Each test vessel was uniquely identified with study code, replicate number, date of experimentation and treatment group.
- Aeration: No aeration of the test solutions occurred throughout the test.
- Renewal rate of test solution: Static (stability of the test item was demonstrated in closed and static conditions during the range-finding test)
- No. of daphnids: 20 per treatment group (including controls), divided into 4 groups of 5 animals
- Loading: 5 daphnids per vessel each completely filled with test solution and without headspace.
- Number of replicates: 4 replicates with 20 daphnids per treatment group.
- Introduction of Daphnids: Daphnids were introduced into the test vessels each completely filled with test solution and without headspace immediately after filling the test vessels with test solutions.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water as prescribed by the OECD Guideline 202

OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark

EFFECT PARAMETERS MEASURED:
- Immobility: Immobility and abnormal behaviour were determined by visual observation after 24 and 48 hours. Immobile animals were eliminated from the vessels as soon as they were discovered. Daphnids were considered to be immobile if they were not able to swim within 15 seconds after gentle agitation of test vessels.
- pH and dissolved O2: At the beginning and at the end of the test from all treatment groups.
- Temperature of Medium: Measured continuously in a temperature controlled vessel next to the test vessels, over the entire study period, beginning at the start of the test.

TEST CONCENTRATIONS
- Range finding study: Ten daphnids per concentration (5 per vessel, in duplicate) were exposed to the following nominal concentrations 1, 10, 100 and 1000 mg.L-1 and to a control.
- Results used to determine the conditions for the definitive study: After the range-finding study, it has been decided to do a limit tests at 100 mg test substance/L for the final test.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
After 24 and 48 hours of exposure, no immobilisation of the test animals was observed in the control and the test concentration of 100 mg.L-1.
Based on these results, the 24 and 48-hour EC50 was therefore > 100 mg test item.L-1.
Results with reference substance (positive control):
On June 3, 2016 (most recent test), the 24h-EC50 was 1.04 mg.L-1. Hence, the sensitivity of the clone of Daphnia magna was in agreement with OECD 202 (1) (expected 24h-EC50: 0.6 mg.L-1 to 2.1 mg.L-1) at this time.
Reported statistics and error estimates:
No statistical analysis was performed. Effective concentrations were determined directly from the raw data.

Analytical results

Duplicate samples taken from the control and the test concentration of 100 mg.L-1 were analysed at the start and the end of the test in order to determine

maintenance of actual concentrations of the test item. The analytical results of this test showed that concentrations of test solutions prepared following the outlined procedures were reproducible. Indeed, analyses of samples taken from the test concentration of 100 mg.L-1 at the start and the end of the test revealed that test item levels found were stable, with losses of test item < 20%. Moreover, since the concentrations of the test item were satisfactorily maintained within ± 20% of the nominal concentrations throughout the test, the results can therefore be based on nominal values.

Table 6.1.3/1: Concentrations of the test item (mg.L-1) in test water - Final test

 Nominal concentration (mg test item/L)     Start (t=0h)        End (t=48h) Mean          Relative loss to initial value (%) 
 

 Control

 Presence  Mean: N/A   Presence   Mean: N/A     N/A
 Control  Presence  Presence  N/A
 100  108.33  Mean: 109.83     95.58     Mean: 97.26  12
 100  111.32  98.94  11

 

Table 6.1.3/2: Acute immobilisation of daphnids after 24 and 48 h in the final test

Nominal concentration (mg test item.L-1)

Replicate

Number of daphnids exposed

Response at 24h

Response at 48h

Number

Total %

Number

Total %

Control

1

2

3

4

5

5

5

5

0

0

0

0

0

0

0

0

0

0

100

1

2

3

4

5

5

5

5

0

0

0

0

0

0

0

0

0

0

Validity criteria of the study:

Controls: In the control, no daphnids became immobilized nor trapped at the surface of the water or showed signs of stress.

Dissolved [O2]: Dissolved oxygen concentration at the end of the test was ≥ 60 % of the air-saturation value in controls and test vessels.

Thus the validity criteria have been fulfilled in the present study.

Validity criteria fulfilled:
yes
Conclusions:
Based on nominal concentrations, the 48-hour EC50 and the highest nominal concentration without observed effects were estimated to be higher than 100 mg test item.L-1.
Executive summary:

A study was performed to assess the acute toxicity of test item 7-METHOXY-3,7-DIMETHYLOCTAN-2-OL MULTICONSTITUENT to Daphnia magna. The method followed was designed to be compliant with Guideline OECD 202 and the study was conducted under GLP conditions.

 

A limit test was performed following the results of a range-finding test. Twenty daphnids (four replicates, five daphnids per replicate) were exposed to the test item at a nominal concentration of 100 mg test item.L-1 and to a control. The immobility of the daphnids was determined in a static 48-hour test by visual observation after 24 and 48 hours. Duplicate samples for analysis were taken from the control and the test concentration of 100 mg.L-1 at the start and at the end of the test (t=48h) in order to determine if the test item concentrations are maintained.

The test item levels were found to be relatively stable throughout the test (within ± 20% of the initial and nominal concentration throughout the test). Thus, the evaluation of the effects on daphnids was based on the nominal concentrations. After 24 and 48 hours of exposure, no immobilisation of the test animals was observed in the control and at 100 mg.L-1.

Therefore, based on nominal concentrations, the 48-hour EC50 and the highest nominal concentration without observed effects were estimated to be higher than 100 mg test item.L-1.

All validity criteria were fulfilled. This study is considered as valid for that endpoint.

Description of key information

Based on nominal concentrations, the 48-hour EC50 and the highest nominal concentration without observed effects were estimated to be higher than 100 mg test item.L-1.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

A reliable experimental study was available.

The study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compliant with Guideline OECD 202 and the study was conducted under GLP conditions.

 

A limit test was performed following the results of a range-finding test.

Analytical analyses indicated that the substance was overall stable throughout the test. Therefore the nominal loading rate of 100 mg/L was used to express the results.

After 24 and 48 hours of exposure, no immobilisation of the test animals was observed in the control and at the loading rate of 100 mg.L-1.

All validity criteria were fulfilled. This study is considered as valid for that endpoint.