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:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: German standard 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): PVP-JOD 30/06
- Lot/batch No.: 34/89
- Analytical purity: > 99 %

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: An aqueous solution was prepared. (1.0 g/100 ml) and subsequently added to the test water.

Test organisms

Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 8.2 cm (range : 7.2 - 9.4 cm )
- Weight at study initiation (mean and range, SD): 5.8 g (range : 4.2 - 8.9 g)


ACCLIMATION
- Acclimation period: 3 days
- Type and amount of food: Growing Feed F/B 50, Ssniff Spezialdiaeten GmbH, Soest, Germany; 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 h

Test conditions

Test temperature:
20 °C
pH:
7.2 - 7.5
Dissolved oxygen:
7.2 - 8.4 mg/l
Nominal and measured concentrations:
Nominal test substance concentrations:
1.00, 2.15, 4.64, 10, 21.5 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: 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: 5.8 g fish/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38 412, part 11


OTHER TEST CONDITIONS
- Photoperiod: 16:8 h 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 after 96 h < 10 mg/l

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
4.64 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
4.64 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.6 - 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.78 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: geometric mean
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
A narcotic like state was observed after 1 and 4 hours exposure at a test substance concentration of 10 mg/l
Reported statistics and error estimates:
FINNEY, D .J ., PROBIT ANALYSIS, CAMBR . UNIV . PRESS, 3RD ED ., 1971

Applicant's summary and conclusion