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: Test procedure comparable with German national standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: DIN 38 412, part 15
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylal
- Batch No.: Barrel No. 517
- Analytical purity: 99.8 %

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
- The test solution was prepared by adding the test item to the test media without any pre-treatment. Then, 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 (Leuciscus idus)
- Source: Fischzucht Paul Eggers, 2354 Hohenweststedt, Germany
- Length at study initiation: 5.1 cm (range 4.8 - 5.7)
- Weight at study initiation: 1.8 g (range 1.4 - 2.7)


ACCLIMATION
- Duration of housing and adaption: about 6 weeks
- Mortality during the adaption period: 0%

Study design

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

Test conditions

Hardness:
about 2.5 mmol/L
Test temperature:
21°C
pH:
about 7.7
Dissolved oxygen:
> 60%
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: All glass aquaria (30 x 22 x 24 cm), Volume of water: 10 L
- Aeration: Continuous aeration with oil-free air, slight
OR No aeration
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: X g fish/L test water


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, Part II, 1982 OR Municipal water of the city of Frankenthal, not chlorinated and passed through a charcoal filter, aerated.
- Alkalinity: pH about 8.0
- Ca/mg ratio: 4 : 1


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


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
observations: mortality and symptoms after 1, 4, 24, 48, 72, and 96 h
measurements: pH and oxygen content after 0, 24, 48, 72 and 96 h


TEST CONCENTRATIONS
Nominal test concentrations: 10, 21.5, 46.4, 100, 215, 464 and 1.000 mg/L. In addition, a control was tested in parallel.
Reference substance (positive control):
yes
Remarks:
chloroacetamide

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 46 - < 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
46 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
and behaviour
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Behavioural abnormalities: Symptoms of intoxication: Narcotic-like state, Tumbling
Details on results:
Nominal Number Dead fish after
conc. of fish
(mg/l) 1 h 4 h 24 h 48 h 72 h 96 h
10 10 0 0 0 0 0 0
21.5 10 0 0 1 1 1 1
46.4 10 0 0 0 0 0 0
100 10 0 6 10 10 10 10
215 10 0 10 10 10 10 10
464 10 0 10 10 10 10 10
1000 10 0 10 10 10 10 10
control 10 0 0 0 0 0 0

Nominal Number Symptoms
conc. of fish
(mg/l) 1 h 4 h 24 h 48 h 72 h 96 h
10 10 - - - - - -
21.5 10 - - - - - -
46.4 10 - - - - - -
100 10 T N
215 10 N
464 10 NT
1000 10 N
control 10



Explanation of symptoms:

A = apathy B = abdominal distension
E = exophthalmos F = escape reflex
H = hyperreflexia K = convulsions
L = gasping N = narcotic-like state
T = tumbling U = restlessness
V = discoloration W= headstand
X = accelerated respiration Y= swimming near water surface
(-) = all fish dead

Applicant's summary and conclusion