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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From November 7 to November 17, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
No analytical dose verification
Justification for type of information:
Refer to section 13 for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
(no analytical verification of test conc was done)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
The test solution was prepared in dilution water. The test material was found to be soluble up to 1000 mg/L in water.


Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Not specified
- Source: Toxicon's Daphnia culture
- Age at study initiation: Newly hatched, 6 to 24 h old
- Weight at study initiation: Not specified
- Length at study initiation: Not specified

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
21±1 °C
pH:
7.8±0.2
Dissolved oxygen:
Not specified, initial oxygen saturation > 90%

Salinity:
250±25 mg CaCO3/L


Nominal and measured concentrations:
Nominal: 0, 1, 2, 4, 8 and 16 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: Glass petri dishes with 50 mL solution
- Aeration: The dilution water was initially aerated to an oxygen saturation value of > 90%
- Renewal rate of test solution: Not applicable, static test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): Two
- No. of vessels per control (replicates): Two


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reverse osmosis water

Composition of dilution water: According to ISO test water composition



OTHER TEST CONDITIONS
- Adjustment of pH: When required, it was done with HCl or NaOH
- Photoperiod: 16 h/8 h light: dark
- Light intensity: Subdued, no oher details


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation in the control and test animals at 24 and 48 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
ca. 2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Control dish: Less than 10% immobility was observed in the control at 24 and 48 h.
Test dish: At 16 and 8 mg/L, 100 % immobilisation was observed.
Oxygen saturation: > 97 % oxygen saturation was maintained at the end 48 h. The pH was maintained around 8.0.
For details please refer to the attached results table in the 'background material' section.
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and the NOEC values were 2.0 and 1.0 mg/L, respectively.
Executive summary:

An acute toxicity study was performed to evaluate the immobilisation potential of the read across substance, C8 -18 and C18 -unstad. DEA, in Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to test substance for 48 h at 0, 1, 2, 4, 8 and 16 mg/L under static conditions. Observations were performed at 0, 24 and 48 h to determine the % immobilised daphnids in the control and test vessels. No analytical dose verification was conducted. Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and the NOEC values were determined to be 2.0 and 1.0 mg/L, respectively (Olsson, 1994). Based on the results of the read across study, similar 48 h EC50 and NOEC values are considered for the test substance, C10-12 and C18-unsatd. DEA.

Description of key information

Based on the results of the read across study, the 48 h EC50 and NOEC values of the test substance, C10 -12 and C18 -unsatd. DEA, for toxicity to Daphnia are considered to be 3.2 and 1.0 mg/L (nominal) respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
3.2 mg/L

Additional information

An acute toxicity study was performed to evaluate the immobilisation potential of the read across substance, C8 -18 and C18 -unstad. DEA, in Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to test substance for 48 h at 0, 1, 2, 4, 8 and 16 mg/L under static conditions. Observations were performed at 0, 24 and 48 h to determine the % immobilised daphnids in the control and test vessels. No analytical dose verification was conducted. Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and the NOEC values were determined to be 2.0 and 1.0 mg/L, respectively (Olsson, 1994). Based on the results of the read across study, similar 48 h EC50 and NOEC values are considered for the test substance, C10-12 and C18-unsatd. DEA.

.