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: GLP guideline study, no analytical monitoring

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Naphthalimid
- Analytical purity: > 95 %

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 substance was mixed with the test water and homegenised by Ultra-turrax
- Evidence of undissolved material (e.g. precipitate, surface film, etc): undissolved substance accumulated at the bottom of the test auquaria.

Test organisms

Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: West Aquarium, Bad Lauterberg, Germany
- Length at study initiation (length definition, mean, range and SD): 2.5 - 3.5 cm


ACCLIMATION
- Type and amount of food: Tetra Mm, Tetra Werke, Melle, Germany; ad libitum
- Feeding frequency: twice daily

Study design

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

Test conditions

Test temperature:
22 ± 1 °C
pH:
7.0 - 7.9
Dissolved oxygen:
5.0 - 8.7 mg/l
Nominal and measured concentrations:
Nominal test substance concentrations:
0, 100, 2500, 3500 and 5000 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria (30x22x24 cm)
- Fill volume: 10 l
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to ISO/DIS 7346/1


OTHER TEST CONDITIONS
- Photoperiod: 12:12 h day-night regime
- Light intensity: ca. 700 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms of intoxication after 2 - 4, 24, 48, 72 und 96 hours

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
< 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
ca. 2 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 3 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
ca. 5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
At 1000 and 2500 mg/l the symptoms like reduced activity and necrosis of the gills were observed.
Reported statistics and error estimates:
No LC50-calculation

Any other information on results incl. tables

 Mortalities of fishes:
--------------------------------------------
¦ conc.[mg/l] ¦ 1000 ¦ 2500 ¦ 3500 ¦ 5000 ¦
============================================
¦ after 48 h ¦ 0/10 ¦ 0/10 ¦ 2/10 ¦ 10/10 ¦
--------------------------------------------
¦ after 96 h ¦ 0/10 ¦ 0/10 ¦ 4/10 ¦ 10/10 ¦
--------------------------------------------

Applicant's summary and conclusion