Retinyl acetate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-02-01 - 1993-11-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline 203

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

not relevant

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Retinyl acetate

EC Number:

204-844-2

EC Name:

Retinyl acetate

Cas Number:

127-47-9

Molecular formula:

C22H32O2

IUPAC Name:

(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraen-1-yl acetate

Details on test material:

- Name of test material (as cited in study report): Vitamin A-Acetat
- Physical state: yellow solid
- Storage condition of test material: room temperature, in dark

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Taken from the center of the test vessels immediately before exposure and after 96 h
- Sample storage conditions before analysis: kept at -18 to -22 degrees C

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 4.00 g test substance were mixed with 4.00 g of a mixture 1-methyk-2-pyrrolydone (NMP) / polyoxy-ethylene-sorbitanmonoleate
(TWEEN80) (96%/4%)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): 1-methyk-2-pyrrolydone (NMP) / polyoxy-ethylene-sorbitanmonoleate
(TWEEN80) (96%/4%)
- Evidence of undissolved material (e.g. precipitate, surface film, etc): deposit of test substance was observed in the test vessel at all test times and
test concentrations.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow Trout
- Source: P. Hohler/CH-4314 Zeininge
- Length at study initiation (length definition, mean, range and SD): 50 mm (37-55 mm)
- Weight at study initiation (mean and range, SD): 1.05 g (0.47-1.30 g)
- Feeding during test: no

ACCLIMATION
- Acclimation period: 12 days
- Feeding frequency: 24 h, no food 24 h prior to exposure

Study design

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no data

Test conditions

Hardness:

183 CaCo3/l

Test temperature:

14 ± 1 degrees C

pH:

7.8-8.2

Dissolved oxygen:

70-105% at t=0h to 92-104% at t=96h

Salinity:

not relevant

Nominal and measured concentrations:

nominal concentrations: 0, 10, 18, 32, 58 and 100 mg/L
measured concentration (start): <0.1, 0.1, 0.3, 1.7, 4.0, 15.6
measured concentration at 96h: <0.1 in all exposures

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria of 20 L filled with 15 L (36.22.25 cm)
- Aeration: gentle aeration during exposure
- No. of organisms per vessel: 10
- Biomass loading rate: 0.70 g/L




OTHER TEST CONDITIONS

- Photoperiod:16 h

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.37 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal concentration calculated 43 mg/L, 95%CL 36-51 mg/L

Effect concentrations 2

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

1.37 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal concentration calculated 43 mg/L, 95%CL 36-51 mg/L

Effect concentrations 3

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

1.37 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal concentration calculated 43 mg/L, 95%CL 36-51 mg/L

Effect concentrations 4

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.875 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal concentration calculated 32 mg/L, 95%CL 65-89 mg/L

Effect concentrations 5

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

0.875 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal 32 mg/L

Effect concentrations 6

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

2.03 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal 58 mg/L

Effect concentrations 7

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

4.38 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: nominal concentration calculated 76 mg/L, CL% 65-89 mg/L

Details on results:

- Behavioural abnormalities: Moderate symptoms were disorders in swimming behaviour and respiratory function, loss of equilibrium and severe pigmentation in the 58 mg/L exposure group
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:not relevant
- Effect concentrations exceeding solubility of substance in test medium: not relevant because substance was solubilized

Results with reference substance (positive control):

no data

Reported statistics and error estimates:

Calculated according to Berkson, JASA 48 (1953), 569-599

Any other information on results incl. tables

Sublethal observations / clinical signs:

Test substance is instable in water and was degraded by light and therefore was lost during the test. Due to the fact that a clear dose-effect response was observed the LC50 was cacluated based on average measured concentrations

Applicant's summary and conclusion

Conclusions:

The 96h LC50 of Vitamin A acetate to Rainbow trout was found to be 1.37 mg/l, the 96h NOEC was found to be 0.875 mg/l and the 96 h LC100 was 2.03 mg/L.

Executive summary:

The toxicity of Vitamin A acetate towards Rainbow trout was determined according to OECD Guideline 203 under GLP conditions. Exposure concentrations decreased during exposure period, therefore concentrations are expressed on average measured concentrations. All other validity criteria were met. The 96h LC50 of Vitamin A acetate to Rainbow trout was found to be 1.37 mg/l, the 96h NOEC was found to be 0.875 mg/l and the 96 h LC100 was 2.03 mg/L.