Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 - 14 April 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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
Method C1, Directive 92/69/EEC
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:
At the beginning and then at 96hrs for the 22, 48 and 100 % concentrations. Also ran a stability sample concurrent to look for maintenace of test solution concentration.

Test solutions

Vehicle:
no
Details on test solutions:
100 mg/l solution of A-133816.0
2.5 g of A-133816.0 to test tanks of 25 litres of charcoaled filterd water.
Tank contents ultrasonicated for 3-4 min.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Rainbow trout of (Oncorhynchus mykiss) of length 4-6 cm

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Fish observed at 1, 3, 6 and 24 h and thereafter daily up to 96 h

Test conditions

Hardness:
68 mg CaCO3/l
Test temperature:
14.7-15.2 oC
pH:
missing
Nominal and measured concentrations:
nomimal concentration = 100 mg/l A-133816.0
Details on test conditions:
light cycle of 16 h light and 8 h dark

Results and discussion

Effect concentrationsopen allclose all
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:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Details on results:
LC 50 and NOEC are both greater than 100 mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 for the test substance is estimated to be greater than 100 mg/l
The NOEC for the test sustance is estimated to be greater than 100 mg/l