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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

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

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

Constituent 1
Chemical structure
Reference substance name:
2-(carbamoyloxy)propyl N-[(3-{[3,5-bis({5-[({[2-(carbamoyloxy)propoxy]carbonyl}amino)methyl]-1,3,3-trimethylcyclohexyl}methyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]methyl}-3,5,5-trimethylcyclohexyl)methyl]carbamate
EC Number:
921-910-2
IUPAC Name:
2-(carbamoyloxy)propyl N-[(3-{[3,5-bis({5-[({[2-(carbamoyloxy)propoxy]carbonyl}amino)methyl]-1,3,3-trimethylcyclohexyl}methyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]methyl}-3,5,5-trimethylcyclohexyl)methyl]carbamate
Test material form:
solid
Details on test material:
- Analytical purity: 83.9 g/100g
- Composition of test material, percentage of components: 0.2g/100g water, 13.4g/100g n-butyl acetate, 2.5g/100g 1,2-propanediol, monocarbamate
- Lot/batch No.: 389-48
- Expiration date of the lot/batch: 2019-05-23

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The samples of fresh treatments at test initiation, samples of old and fresh treatments at each renewal
and old treatments at exposure termination were analysed

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 filtrate of the loading rate of
120 mg/L plus the control (as a limit test) in a semi-static test design.
An appropriate amount of the test item was weighed in a glass crystalliser, transferred into a glass
vessel and filled up with a corresponding volume of the Elendt M7 test medium (Table 3.) [SOP/W/7].
The mixture of a loading rate of 120 mg/L was visually heterogeneous with undissolved particles.
Therefore, the mixture and the control (the ELendt M7 test medium, 1000 mL) were mechanically
shaken for 48 h (room temperature, 90 revolutions per minute). After 48 h of mechanical shaking, the
mixture (heterogeneous) and the control were stored at room temperature for a settling phase (no
shaking). After 24 h of settling phase, the mixture was still visually heterogeneous. Therefore, the
mixture and the control were filtered through a conditioned nitrocellulose membrane filter (0.45 Sm,
Millipore, under vacuum), [SOP/W/37]. The conditioning was by pre-filtering a small volume of either
the test item loading rate or the control to saturate the filter (and disposing it) before filtering the
volumes for exposure. Each filtrate was visually homogeneous and transparent. This is a WAFapproach
followed by filtering, which results in a water soluble fraction

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

Hardness:
154 mg/L as CaCO3
Test temperature:
19.2 – 19.8ºC
pH:
The pH values measured at exposure initiation were in the range of 7.50 – 7.51. At renewal, the pH
values measured in old treatments were all 7.63 and in the range of 7.55 – 7.60 in fresh treatments.
The pH values at exposure termination were in the range of 7.51 – 7.59
Dissolved oxygen:
The dissolved oxygen
concentrations measured at exposure initiation were in the range of 8.3 – 8.6 mg/L. At renewal, the
dissolved oxygen concentrations measured in old treatments were in the range of 8.2 –
8.5 mg/L and 7.7 – 7.9 mg/L in fresh treatments. The dissolved oxygen concentrations measured at
exposure termination were in the range of 8.1 – 8.4 mg/L
Conductivity:
418 SS/cm
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
Filtrate of a loading rate of 120 mg/L plus the control
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Applicant's summary and conclusion

Validity criteria fulfilled:
yes