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. Comparable to OECD 203.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: German standard, DIN 38 412 L15.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Methylbuten-3-ol-1
- Lot/batch No.: 31-0342
- Analytical purity: 99%;
water solubility: 90 g/l, according to sponsor.

Sampling and analysis

Analytical monitoring:
no

Test solutions

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 substance 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
- Source: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany  
- Length at study initiation (length definition, mean, range and SD): 6.7 cm (range 5.7 - 7.2 cm)
- Weight at study initiation (mean and range, SD): 2.9 g (range 1.5 - 4.4 g)
- Feeding during test: 1 day before and during exposure
- Corpulence factor of the test fish batch: 0.95
- Housing and adaption  Culture conditions: oil-free aerated and charcoal filtered tap water,  flow-through system Water temperature: 20 -  21 °C   Duration of housing: about 2 months  Mortality during the last 2 weeks of housing: 2.3 % , Medical treatment: Twice with 0.05 mg/l malachite green chloride, once  with 10 mg/l tetracycline hydrochloride. 

ACCLIMATION
- Acclimation period: 3 days
- Type and amount of food: Growing feed F/B 50, ad libitum. 
- 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:
21 °C 
pH:
7.3 - 7.6 
Dissolved oxygen:
6.9 - 8.7 mg/l
Nominal and measured concentrations:
Nominal test concentrations: 46.4, 100, 215, 464, 1000 mg/l (based on the  results of a range-finding test). In addition, a control containing test  water only was tested in parallel. 
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: 4.4 g fish/l test water


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, Part II,  1982; prepared from fully demineralised tap water (conductivity: max 10  micro MHO) 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 
- Ratio Na/K ions: 10 : 1
- Acid capacity: 0.8 mmol/l
- Ca/mg ratio: 4 : 1


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 h.

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
460 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
460 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
681.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1 000 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).
Reported statistics and error estimates:
The EC50 value was calculated as the geometrical mean of the LC0 (464.  mg/l) and the LC100 (1000 mg/l) value.

Any other information on results incl. tables

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

Nominal test       Cumulative mortalitiy (%) after x hours
concentration       1  /  4  / 24  / 48  / 72  / 96
(mg/l)
Control             0  /  0  /  0  /  0  /  0  /  0
46.4                0  /  0  /  0  /  0  /  0  /  0
100.0               0  /  0  /  0  /  0  /  0  /  0
215.0               0  /  0  /  0  /  0  /  0  /  0
464.0               0  /  0  /  0  /  0  /  0  /  0
1000.0              1  /  2  / 10  / 10  / 10  / 10

Symptoms of intoxication:

Nominal test       Symptoms of intoxication after x hours
concentration      1 / 4 /24 / 48 / 72 / 96
(mg/l)
Control             - / - / - / - / - / -
46.4                - / - / - / - / - / -
100.0               - / - / - / - / - / -   
215.0               - / - / - / - / - / -
464.0               - / - / - / - / - / -
1000.0              T / T / + / + / + / +

Definitions of Symptoms:
-: No symptoms
+: All fish dead
T: Tumbling

All results refer to nominal test concentrations of 3-methylbuten-3-ol-1.
No analytical dose-verification of the test item was carried out.

Behavior of the test item during the test:
No remarkable observations.

Applicant's summary and conclusion