Escin

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:

2016

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

17 july 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

April 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Escin

EC Number:

229-880-6

EC Name:

Escin

Cas Number:

6805-41-0

Molecular formula:

C110H172O48

IUPAC Name:

(2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-[(2-methylbutanoyl)oxy]-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid; (2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-{[(2E)-2-methylbut-2-enoyl]oxy}-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid

Test material form:

solid: bulk

Specific details on test material used for the study:

Horse Chestnut dry hydroalcoholic extract contained 18-22% of escin

Test organisms

Test organisms (species):

other: Zebrafish (Brachydanio rerio)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

4 d

Post exposure observation period:

none

Test conditions

Hardness:

249 mg/L (as CaCO3)

Test temperature:

21.7-22.6 °C

pH:

6.86-7.42

Dissolved oxygen:

63.4-83.6%

Nominal and measured concentrations:

Nominal: 2.5, 5, 10 , 20 and 40 mg/L

Details on test conditions:

The acquariums were kept in a climate chamber. The water temperature, pH value and dissolved oxygen concentration were determined at the start of the test and on the subsequent days (once daily) in each test concentration and in the control.
Temperature: The acquariums were kept in a climate chamber. The measured temperatures were whitin a range of 21.7 - 22.6 °C in the acquariums (the maximum deviation did not exceed +-1°C).
Oxygen concentartion: The dissolved oxygen concentration was in the range of 63.4 - 83.6% of the saturation value at the temperature used.
pH: The test was carried out without adjustement pf pH. The measured pH value were in the range 6.86 - 7.42 during the test.
Light-Dark cycle: The light-dark cycle during the test was 16 hours light (artificial illumination) and 8 hours darkness.
Hardness: the reconstituted water (ISO medium) has an aproximate theoretical total harness of 249 mg/L (CaCO3).
Duration of the test: 96 hours
Feeding: The fish were not fed during the test.

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

4 d

Dose descriptor:

LC50

Effect conc.:

ca. 7.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Key result

Duration:

4 d

Dose descriptor:

NOEC

Effect conc.:

5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: hightest concentaration at which no significant effect on the test animals is observed

Effect concentrations 3

Key result

Duration:

4 d

Dose descriptor:

LC0

Effect conc.:

5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Key result

Duration:

4 d

Dose descriptor:

LOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: the lowest test concentration at whitch as significant effect on the test animals is observed

Effect concentrations 5

Key result

Duration:

4 d

Dose descriptor:

LC100

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

In this 96-hours static acute toxicity on Zebrafish (Bracydanio rerio) the test item (Horse-Chestnut dry hydroalcoholic extract 16-22%) has significant toxic effects on fish.
The 96-hours LC50 value was determined to be 7.1 mg/mL
The highest test concentration causing no mortality within the test period (96-Hours LC0) was determined to be 5.0 mg(mL and the lowest test concentartion causing 100% mortality within the test period (96-hours LC100) was determined to be 10 mg/mL

Any other information on results incl. tables

Sublethal observations / clinical signs:

96 -h LC50 by Probit analysis 95% conf. limits	Nominal concentration:  7.1 mg/L 4.80 - 9.9
96-h NOEC	5 mg/L
96 -h LC0	5 mg/L
96 -h LOEC	10 mg/L
96 -h LC100	10 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this 96-hours static acute toxicity on Zebrafish (Bracydanio rerio) the test item (Horse-Chestnut dry hydroalcoholic extract 16-22%) has significant toxic effects on fish.
The 96-hours LC50 value was determined to be 7.1 mg/mL
The highest test concentration causing no mortality within the test period (96-Hours LC0) was determined to be 5.0 mg(mL and the lowest test concentartion causing 100% mortality within the test period (96-hours LC100) was determined to be 10 mg/mL