Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: DIN 38412 part L15
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethylharnstoff (1,3-Dimethylurea)
- Analytical purity: 97.5 %

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:The test solution was prepared by adding the test item to the test media without any pre-treatment. Subsequently the fish were placed into the test aquaria.

Test organisms

Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Source: Fish farm Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 7.3 cm (range 6.9 - 7.9 cm)
- Weight at study initiation (mean and range, SD): 3.4 g (range 2.5 - 5.0 g)


ACCLIMATION
- Acclimation period: 3 days
- Type and amount of food: Growing feed F/B 50, ad libitum
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no mortality observed

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96

Test conditions

Hardness:
2.5 mmol/l
Test temperature:
20 °C
pH:
7.3 - 7.5
Dissolved oxygen:
8.1 - 8.6 mg/l
Nominal and measured concentrations:
Nominal test concentrations:
1000, 2150, 4640, and 10000 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: All glass aquaria (30 x 22 x 24 cm)
- Fill volume: 10 l
- Aeration: slight
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 3.4 g fish/l test water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Test water: reconstituted freshwater according to DIN 38412, Part II, 1982; prepared from fully demineralised tap water by adding: 294.0 mg/l CaCl2 * 2 H2O, 123.3 mg/l MgSO4 + 7 H2O, 63.0 mg/l NaHCO3, 5.5 mg/l KCl
- Ca/mg ratio: 4:1
- Conductivity: max 10 micro MHO


OTHER TEST CONDITIONS
- Photoperiod: 16 : 8 hours day-night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication.after 1, 4, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Results used to determine the conditions for the definitive study: LC50 896h) 1000 - 10000

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
4 600 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Results with reference substance (positive control):
48 h-LC50 of the positive control chloroacetamide: about 32 mg/l (corresponds to normal sensitivity).

Any other information on results incl. tables

During the 96 h exposure to 1,3-dimethylurea, mortalities were as follows:

Nominal test / Cumulative mortality (%) after x hours
concentration/ 1 / 4 / 24 / 48 / 72 / 96 /
(mg/l
Control / 0 / 0 / 0 / 0 / 0 / 0 /
1000 / 0 / 0 / 0 / 0 / 0 / 0 /
2150 / 0 / 0 / 0 / 0 / 0 / 0 /
4640 / 0 / 0 / 0 / 0 / 0 / 0 /
10000 / 0 / 0 / 10 / 10 / 30 / 60 /


Symptoms of intoxication:

Nominal test / Symptoms of intoxication after x hours
concentration / 1 / 4 / 24 / 48 / 72 / 96 /
(mg/l)
Control / - / - / - / - / - / - /
1000 / - / - / - / - / - / - /
2150 / - / - / - / - / - / - /
4640 / - / - / - / - / - / - /
10000 / - / - / - / - / - / A /

Definitions of Symptoms:
-: No symptoms
A: Apathy

Applicant's summary and conclusion