Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 09-04-2018 to 12-04-2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
13/04/2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
30/05/2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES
Version / remarks:
14/12/2000
Deviations:
not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Cas Number:
99474-22-3
Molecular formula:
C19H20N2O3
IUPAC Name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-

Sampling and analysis

Analytical monitoring:
yes
Remarks:
The content of the test item in the test solutions was estimated by calculation based on the organic carbon content of the test item and DOC measurement.

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical.
The husbandry is performed similar to the method described in the OECD guideline.
- Vessels: preserving glasses, nominal volume 2 L
- Medium: M4-Medium (recipe of ELENDT)
- Food: green algae (Desmodesmus subspicatus)
- Medium renewal: twice a week
- Photo period: 16/8 hours, using neon tubes
- Temperature: 20 +/- 2 °C

Study design

Test type:
static
Water media type:
freshwater
Remarks:
ISO test water
Limit test:
yes
Total exposure duration:
48 h
Remarks on exposure duration:
none
Post exposure observation period:
none

Test conditions

Hardness:
2.502 mg/L
Test temperature:
20 +/- 2°C
pH:
pH ranged from 7.9 to 8.0
Dissolved oxygen:
> 8 mg/L
Salinity:
-
Conductivity:
-
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Reference substance (positive control):
yes
Remarks:
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 2.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: equivalent concentration of test item based on Dissolved Orgnic Carbon determination
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 2.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: equivalent concentration of test item based on Dissolved Organic Carbon determination
Basis for effect:
mobility

Any other information on results incl. tables

Findings

Immobility

Nominal Concentration in mg/L

Immobility24hours

Immobility48hours

absolute

in %

absolute

in %

Blank control

0

0

0

0

0

0

0

0

0

0

100

0

0

0

0

0

0

0

0

0

0

 

pH and O2

Nominal Concentration in mg/L

pH

O2-Concentration in mg/L

0 h

48 h

0 h

48 h

Blank control

8.0

7.9

8.5

8.2

100

7.9

7.9

8.4

8.2

 

Analytical determinations

The measured concentration at the beginning of the test was 2 % of the nominal concentration and after 48 hours the measured concentration was 2 % of the nominal concentration. Therefore, the determination of the biological results was based on the geometric mean of the measured concentration.

Since measured concentrations lay in a close range to the blank control, nominal concentrations are also given in the result tables.

The measured concentrations for treatment and blank control are given in the following table:

Nominal
Concentration Test Item

Measured

TC
 t = 0 h

Measured

TC
 t = 48 h

Measured

IC
 t = 0 h

Measured

IC
 t = 48 h

mg/L

mg/L

mg/L

mg/L

mg/L

Blank control

9.84

12.68

9.48

11.06

100

11.48

13.93

9.54

10.89

LOQ (Limit of quantification) TC = 5.43 mg/L

LOQ (Limit of quantification) IC = 2.03 mg/L

Nominal
Concentration Test Item

Measured

DOC (TC-IC)
 t = 0 h

Measured DOC (TC-IC)
 t =48 h

Measured

DOC minus blank control
t = 0 h

Measured

DOC minus blank control t = 48 h

mg/L

mg/L

mg/L

mg/L

mg/L

Blank control

0.36

1.61

--

--

100

1.94

3.04

1.58

1.43

 

Nominal
Concentration Test Item

Calculated

Concentration

 Test Item
 t = 0 h

Calculated

Concentration

 Test Item
 t = 48 h

% of Nominal concentration
t = 0 h

% of Nominal concentration
t = 48 h

mg/L

mg/L

mg/L

%

%

Blank control

--

--

--

--

100

2.3

2.0

2

2

 

Nominal Concentration Test Item

Geometric Mean of measured concentrations

mg/L

mg/L

Blank control

--

100

2.1

 

Results

No toxicity occurred no statistical evaluation was conducted.

Parameter

Geometricmean

Nominal

24h EC50

> 2.1 mg/L

> 100 mg/L

48h EC50

> 2.1 mg/L

> 100 mg/L

48h NOEC

2.1 mg/L

100 mg/L

48h LOEC

> 2.1 mg/L

> 100 mg/L

 

Validity

•            Immobilisation in the controls may not exceed 10 %. Immobilisation in the controls was 0 %.

•            The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L. The lowest concentration of dissolved oxygen at the end of the test was 8.2 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
At the end of the test no toxicity was observed in the treatment and also none of the animals was immobilized in the blank control.
Executive summary:

A GLP-study was perform to asses the short term toxicity of the test item againstDaphnia magnaSTRAUS according to OECD 202 resp. EU C.2. The study was performed as a limit test using one concentration at 100 mg/L. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilized daphnia were counted. At the end of the test no toxicity was observed in the treatment and also none of the animals was immobilized in the blank control.

The following results were determined for the test item (species: Daphnia magna):

-       48h NOEC ≥ 100 mg/L;

-       48h EC50 > 100 mg/L.