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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

1
Chemical structure
Reference substance name:
4-{[(6-{2,4,6-trioxo-3,5-bis[6-({[4-(prop-2-enoyloxy)butoxy]carbonyl}amino)hexyl]-1,3,5-triazinan-1-yl}hexyl)carbamoyl]oxy}butyl prop-2-enoate
EC Number:
929-915-1
IUPAC Name:
4-{[(6-{2,4,6-trioxo-3,5-bis[6-({[4-(prop-2-enoyloxy)butoxy]carbonyl}amino)hexyl]-1,3,5-triazinan-1-yl}hexyl)carbamoyl]oxy}butyl prop-2-enoate

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The definitive test was performed using a single test item concentration: filtrate of a loading of
100 mg/L as a limit test plus the control in a semi-static test design.
Appropriate amount of the test item was weighed in a glass flask partially filled with the Elendt M7
medium and filled up with appropriate volume of the Elendt M7 medium [SOP/W/7].
The mixture of a loading of 100 mg/L was visually heterogeneous. Therefore, the mixture and the
control (the Elendt M7 medium, 800 mL) were mechanically shaken for 48 h (30ºC, darkness,
90 revolutions per minute). After 48 hours of mechanical shaking, the mixture (heterogeneous) and the
control were stored at room temperature for a settling phase (no shaking). After 24 hours of settling
phase, the mixture was still visually heterogeneous. Therefore, the mixture and the control were
filtered through a conditioned nitrocellulose membrane filter (0.22 Tm, Millipore), [SOP/W/37]. This is a
WAF-approach followed by filtering which results in a water soluble fraction [9]. The conditioning was
by pre-filtering a small volume of either the test item loading or the control to saturate the filter (and
disposing it) before filtering the volumes for exposure. Filtration was chosen as the separation method
since centrifugation is not possible with the large volumes of test solution. Each filtrate was visually
homogeneous and transparent.
From all filtrates, two samples were collected for chemical analyses (100 mL each). One was
transferred to chemical analyses at exposure initiation, the second one was stored under test
conditions [SOP/W/83].
After 24 h of exposure, the test item concentrations and the control were renewed.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Source: Standard laboratory culture maintained in the Institute of Industrial Organic Chemistry, Branch Pszczyna, Department of Ecotoxicology, Laboratory of Aquatic Toxicology [SOP/W/67]
- Age at study initiation (mean and range, SD): < 24 hours
- Method of breeding: Daphnia magna was cultured in glass beakers of 150 mL volume (one parent per vessel) at room temperature 18 – 22o C with the light : dark ratio of 16 h : 8 h (electronic time programmer, KANLUX, Poland). The culture was maintained in Elendt M7 medium [SOP/W/63, SOP/W/67].
- Feeding during test: none

ACCLIMATION
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Pseudokirchneriella subcapitata algae suspension. Group B vitamins and micronutrients necessary for proper growth were supplied with lyophilized Spirulina sp. suspension.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Type (delete if not applicable): covered with transparent lids in order to minimize evaporation and to prevent accidental contamination
- Material, size, headspace, fill volume: 150 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16:8 light:dark

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Applicant's summary and conclusion

Validity criteria fulfilled:
yes