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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 conducted in accordance with GLP, however no analytical determination of the test substance was performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1998

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Retinyl propionate
EC Number:
230-363-2
EC Name:
Retinyl propionate
Cas Number:
7069-42-3
Molecular formula:
C23H34O2
IUPAC Name:
retinyl propionate
Details on test material:
- Vitamin A-propionat 2.5 Mio.
- Identification Code: 04-4097-3
- Purity: approx. 95 %
- Batch No.: 6269, ABLAGE-NR. 80-7031
- Water solubility: insoluble (according to sponsor)

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solution was prepared by adding the test item to the test media without any pre-treatment. Subsequently 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
- Supplier: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany
- Body length: 6.1 cm (range 5.7 - 6.6 cm)
- Body weight: 2.8 g (range 2.4 - 3.9 g)
- Corpulence factor of the test fish batch: 1.26

HOUSING AND ACCLIMATION
- Culture conditions: oil-free aerated and charcoal filtered tap water, flow-through system
- Water temperature: 15 - 20 °C
- Duration of housing: about 3 months
- Mortality during the last 2 weeks of housing: 0.03 %
- Mortality during the adaption period: 0 %
- Medical treatment: twice with 0.05 mg/l malachite green chloride, once with 10 mg/l tetracycline hydrochloride
- Diet: Growing feed F/B 50, ad libitum
- Adaption to test water and test temperature: 3 days

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:
21 °C
pH:
7.7 - 8.2
Dissolved oxygen:
7.3 - 8.5 mg/L
Nominal and measured concentrations:
Nominal test concentrations: 5000 and 10000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessels: All glass aquaria (30 x 22 x 24 cm)
- Volume of water: 10
- No of animals per test concentration and control: 10
- Loading rate (g fish/l test water): 2.8
- Aeration: slight
- Withdrawal of food: 1 day before and during exposure

TEST MEDIUM / WATER PARAMETERS
- 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
- Aeration:Continuous aeration with oil-free air
- Acid capacity: 0.8 mmol/l
- Ratio Ca/Mg ions: 4 : 1
- Ratio Na/K ions: 10 : 1
- pH: about 8.0

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

EFFECT PARAMETERS MEASURED: mortality and symptoms of intoxication after 1, 4, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Test concentrations based on the results of a range-finding test

Results and discussion

Effect concentrationsopen allclose all
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:
NOEC
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
- During the 96 h exposure to Vitamin A propionate no mortalities or symptoms of intoxication were detected.
- No analytical dose-verification of the test substance was carried out.
- Oily, drop-shaped test substance was visible on the water surface

Applicant's summary and conclusion