Registration Dossier

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:
2017-04-03 - 2017-06-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
guideline study accordin to GLP

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

Constituent 1
Chemical structure
Reference substance name:
Reaction product of 2-hydroxyethylacrylate with imidazole
EC Number:
926-135-3
Cas Number:
1181222-25-2
Molecular formula:
not applicable
IUPAC Name:
Reaction product of 2-hydroxyethylacrylate with imidazole
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:Batch: 0015609877,
- Expiration date of the lot/batch: Expiry date: 18 Aug 2017



Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
The test organism, Daphnia magna Straus, originated from the standard laboratory culture cultivated at the Institute of Industrial Organic Chemistry, Branch Pszczyna, Department of Ecotoxicology [SOP/W/67]. Only organisms up to 24 hours old (not first brood progeny) and in good physiological condition were used in the tests. The sensitivity of the culture was monitored on a regular basis using a reference material potassium dichromate [SOP/W/72].

Culturing Daphnia magna
Daphnia magna was cultured in glass beakers with a capacity of 150 mL (one parent per vessel) containing 100 mL of the Elendt M7 medium at room temperature with daily cycle 16 h light : 8 h dark
(KANLUX electronic time programmer, Poland).
The culture was maintained in the Elendt M7 medium [SOP/W/63, SOP/W/67]. The Daphnia magna were fed with a suspension of algae; mixture of two species Pseudokirchneriella subcapitata:
Desmodesmus subspicatus (in 2:1 ratio) originating from separate cultures in the Laboratory of Aquatic Toxicology [SOP/W/65]. Group B vitamins and micronutrients necessary for proper growth were
supplied with the lyophilized suspension of Spirulina sp.. The Daphnia magna used in the tests were less than 24 h old.

Study design

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

Test conditions

Hardness:
Temperature: 19.1 – 20.6ºC; pH of the control: 7.76 – 7.97; dissolved
oxygen concentration in the control: 8.3 – 8.7 mg/L; daily cycle
16 h light : 8 h dark; fluorescent light source; no feeding; no aeration; medium: Elendt M7.Temperature: 19.1 – 20.6ºC; pH of the control: 7.76 – 7.97; dissolved oxygen concentration in the control: 8.3 – 8.7 mg/L; daily cycle 16 h light : 8 h dark; fluorescent light source; no feeding; no aeration; medium: Elendt M7.
Details on test conditions:
Test conditions
The acute immobilization tests on Daphnia magna were performed according to the OECD Guideline for the Testing of Chemicals No. 202 (2004) [1] and the SOP/W/21. The tests were conducted in a semi-static design with exposure for 48 h. The Elendt M7 medium was used as a diluent necessary to prepare the test item concentrations. The Daphnia magna were exposed in glass beakers of 150 mL capacity, containing 100 mL of either test item concentration or the control in the preliminary test, and 125 mL of test item concentration or the control in the definitive test. The beakers were covered with transparent lids in order to minimize evaporation and to prevent accidental contamination. Each treatment was split up into four replicates. Five individuals of Daphnia magna were introduced into each replicate; hence, in the definitive test there were 25 mL of a given treatment per Daphnia magna (the OECD Guideline No. 202 requires at least 2 mL) [1]. During exposure, the Daphnia magna were not fed, and the temperature was continuously recorded using a sensor submerged in an additional test vessel with the Elendt M7 medium [SOP/W/51]. The pH values and the dissolved oxygen concentrations were measured in each treatment at exposure initiation before splitting up into replicates and at renewal (fresh). At renewal and at exposure termination (24-hour old), the pH values were measured in pooled replicates of each treatment [SOP/W/36]. Each test was conducted with a daily light cycle of 16 h light : 8 h dark (KANLUX electronic time programmer, Poland). Fluorescent lighting was used.

Preliminary non-GLP test
The preliminary test was performed in a semi-static test design. The following test item concentrations: 100, 10 and 1.0 mg/L plus the control were used for exposure. The appropriate amount of the test item was weighed in a glass flask and filled up with appropriate volume of the Elendt M7 medium [SOP/W/7]. The test item concentration of 100 mg/L was visually homogeneous and transparent directly after preparation and throughout the exposure period. Lower test item concentrations were prepared by sequential dilutions with the Elendt M7 medium in a ratio 1:9 (v/v) (i.e. 50 mL of higher test item concentration was mixed with 450 mL of the Elendt M7 medium). The control was the Elendt M7 medium (400 mL). After 24 h of exposure, the test item concentrations and the control were renewed.

Definitive test
The definitive test was performed in a semi-static test design, since the stability of the test item over the exposure period cannot be demonstrated with the unspecific analytical method. The definitive test was performed with a single test item concentration of 100 mg/L as a limit test plus the control [1]. The appropriate amount of the test item was weighed in a glass crystallizer and quantitatively transferred into volumetric flask by multiple washing with Elendt M7 medium [SOP/W/7]. The content of
flask was filled up with appropriate volume of Elendt M7 medium. The control was 1000 mL of Elendt M7 medium (Table 3). The test item concentration was visually homogeneous and transparent. The appearance of the test item concentration remained unchanged throughout the exposure period. After 24 h of exposure, the test item concentration and the control were renewed. At exposure initiation and at renewal (samples freshly prepared), a sample of the test item concentration of 100 mg/L and four samples of the control were collected and transferred for chemical analyses [SOP/W/83]. At renewal (24-hour old samples) and at exposure termination, samples of the test item concentration of 100 mg/L and separate samples of all replicates of the control were collected and analysed.

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In an OECD 201 test (limit test) with Daphnia magna, the EC50 and NOEC reached values of > 100 mg/l.

Categories Display