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:
March 5-11 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
424-660-8
EC Name:
-
Cas Number:
224631-15-6
Molecular formula:
Hill formula: C18H26N4O5S CAS formula: C18H26N4O5S
IUPAC Name:
(S)-2,5-dioxopyrrolidin-1-yl 2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-3-methylbutanoate

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Chemical anlaysis was completed on samples to confirm concentrations. HPLC was used.

Test solutions

Vehicle:
no
Details on test solutions:
A 100 mg/l "aged" stock slution of A-133816.0 was prepared by adding a weighed amount of A-1338163.0 (0.498g) to a 5L volumettric flask and bringing the flask to volume with Daphnia medium.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Fill in what you can

TEST ORGANISM
- Common name: water flea
- Strain: 278/4
- Source: CCAP, Ambleside, Cumbria
- Age at study initiation (mean and range, SD):
- Weight at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD):

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Those animals which were unable to swim within 15 s following gentle agitation of the test contianer were considered immobile. No immoblie Daphnia were recorded during the study.

Test conditions

Hardness:
164 mg CaCO3 mg/l
Test temperature:
19.6-20.3 oC
pH:
pH was monitored
Nominal and measured concentrations:
Nominal concentration = 100 mg/l "aged solutuon"

Chemical analysis was conducted on the "aged" solutions to confirm that A-133816.0 had degraded to 2,4-wing acid.
Details on test conditions:

- Test vessel: glass crystallising dishes
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 200 ml capacity
- Aeration: ventilation holes
- Renewal rate of test solution (frequency/flow rate):
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates):




OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 hour dark. Illumination provided by artificial daylight fluroescent tubes


TEST CONCENTRATIONS
- Range finding study: Basedon the results of hydrolysis studies conducted under INveresk Project No. 374979, a limit test was conducted on an "aged" solution of 100 mg/l nominal A-133816.0

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
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
Conclusions:
The EC50 for immobilisation and NOEC are >100 mg/l nomial "aged" A-133816.0