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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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, scientifically acceptable.

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7,11,15-tetramethylhexadec-1-en-3-ol
EC Number:
208-008-8
EC Name:
3,7,11,15-tetramethylhexadec-1-en-3-ol
Cas Number:
505-32-8
Molecular formula:
C20H40O
IUPAC Name:
3,7,11,15-tetramethylhexadec-1-en-3-ol
Details on test material:
- Name of test material (as cited in study report): 3,7,11,15-Tetramethyl-1-hexadecen-3-ol (Isophytol)
- Analytical purity: 97.6 %
Water solubility: insoluble

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 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
- Source: Fish farm, Paul Eggers, 2354 Hohenweststedt, 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)
- Corpulence factor of the test fish batch: 0.95
- Feeding during test: 1 day before and during exposure.
- Housing: 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: about 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

Hardness:
2.5 mmol/l
Test temperature:
20 (+/- 1) °C
pH:
7.2 - 7.8
Dissolved oxygen:
8.3 - 9.0 mg/l
Nominal and measured concentrations:
Nominal test concentrations (mg/l):
0, 5000, and 10000
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: 5.0 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 (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
- Ration 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.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
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:
NOEC and LC50 were determined directly from the raw data.

Any other information on results incl. tables

Sublethal observations / clinical signs:
During the 96 h exposure to isophytol, 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 /
5000 0 /0 /0 /0 /0 /0 /
10000 0 /0 /0 /0 /0 /0 /


Symptoms of intoxication:

Nominal test Symptoms of intoxication after x hours
concentration /1 /4 /24/48/72/96/
(mg/l)
Control /- /- /- /- /- /- /
5000 /- /- /- /- /- /- /
10000 /- /- /- /- /- /- /


Definitions of Symptoms:
-: No symptoms

All results refer to nominal test concentrations of isophytol.
No analytical dose-verification of the test item was carried out.

Applicant's summary and conclusion