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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Cited as Directive 84/449/EEC, C.1 ("Acute toxicity for fish")
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
EC Number:
406-640-0
EC Name:
A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
Cas Number:
136920-07-5
Molecular formula:
C58H114N4O6 - C154H308N6O4
IUPAC Name:
Reaction mass of 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C12-C18)alkylacetamide and {[2-(Carboxymethyl-di(C12-C18)alkylcarbamoylmethyl-amino)-ethyl]-di(C12-C18)alkylcarbamoylmethyl-amino}-acetic acid
Constituent 2
Reference substance name:
Keroflux ES 3241
IUPAC Name:
Keroflux ES 3241
Details on test material:
Test Substance No.: 90/763
Batch No.: Partie 1 (T 75492/ST 1414/90)

Water solubility: < 0.6 mg/L

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The test concentrations were analyzed by determination of DOC in the test water. Test samples were taken at 1 hour and 96 hours after test start.

Test solutions

Vehicle:
yes
Details on test solutions:
The compound was added to the test water separately for each concentration by mixing with 1 g Tween 80 (100 mg/L). Then, aqua bidest was added in small quantities and the solution was transferred into the test water. A solvent control with the same concentration of solubilizer was run in parallel.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Common name: Zebra fish
- Source: West Aquarium GMBH, Bad Lauterberg, FRG
- Length at study initiation: 2.9 cm (2.2 - 3.4)
- Weight at study initiation: 0.25 g (0.17 - 0.37)
- Duration of housing and adaptation: about 1.5 months
- Mortality during the last 2 weeks of housing: about 0.8 %
- Medical treatment: None
- Adaptation to the test water: 7 days

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
total hardness: 2.5 mmol/L
Test temperature:
22-23 °C
pH:
about 8
Dissolved oxygen:
continuous aeration
Nominal and measured concentrations:
Based on the results of several range finding studies, the test substance was tested at a range of concentrations: 0, 10.0, 21.5, 46.4, and 100 mg/L.
Details on test conditions:
- Photoperiod: 16 hours light and 8 hours darkness
- Volume of water: 10 Liters
- No. of animals per test concentration: 10
- Test vessels: All-glass aquarium (30 cm X 22 cm x 24 cm)
- Test water: Reconstituted freshwater according to DIN 38 412, Part 11
- Aeration: Continuous with oil-free air

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:
Mortality / Symptoms:
---------------------
No mortality or any symptoms of intoxication were observed at any test concentration.

Concentration control analysis:
-------------------------------
Nominal Conc. DOC [mg/l]
1 h 96 h
-----------------------------------------------------------
10.0 47.5 58.4
21.5 43.9 57.1
46.4 41.6 57.3
100 47.2 55.6

control 1.5 0.6
solvent control 44.1 56.5
-----------------------------------------------------------

The results of the concentration control analysis confirmed the insolubility of the test substance in water even in the presence of a solubilizer.

Applicant's summary and conclusion