Etilefrine

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Commission Directive 92/69/EEC, Annex Part C, C.2: "Acute Toxicity for Daphnia", Official Journal of the European Com-munities No. L 383 A, dated December 29, 1992.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for Testing of Chemicals, Section 2, No. 202: "Daphnia sp., Acute Immobilisation Test and Reproduction Test", Part I, adopted April 04, 1984.

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Additionally the recommendations of the EPA Guideline 712¬C-96-114: OPPTS 850.1010, "Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids" April 1996 were taken into account.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Etilefrine

EC Number:

211-910-4

EC Name:

Etilefrine

Cas Number:

709-55-7

Molecular formula:

C10H15NO2

IUPAC Name:

3-[2-(ethylamino)-1-hydroxyethyl]phenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name : Effortil-Rohbase
Batch No.: 310
Aggregate State at RT: solid
Colour: white
Purity: >98%
Analysis: meldting point
Certificate of Analysis: 19.07.2000
Sorage: in original container, at room temperature

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species
Daphnia magna (Straus), clone 5

Age at Test Start
6 - 24 hours old

Sex
female

Origin
supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany
The Daphnia were bred in the laboratories of IBACON under similar temperature and light conditions as in the test, and in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test. The test organisms were not first brood progeny.
For the evaluation of the quality of the Daphnia clone and the experimental conditions the substance potassium dichromate p.A. (E. Merck, Darmstadt, Germany) is tested at least twice a year to demonstrate satisfactory test conditions.
for 6 hours under test conditions.

Study design

Test type:

static

Total exposure duration:

48 h

Test conditions

Hardness:

2.5mmol/L as CaCO3

Test temperature:

21°C

pH:

7,8 to 9.2

Dissolved oxygen:

at least 8.7 mg/L or higher

Salinity:

CaC12 x 2H20
2.0mmol/L

MgSO4 x 7H20
0.5mmol/L

NaHCO3
0.75mmol/L

KCl
0.075mmol/L

Alkalinity
0.8mmol/L

ratio of Ca : Mg
4 : 1 (based an molarity)

Na : K
10 : 1 (based an molarity)

Nominal and measured concentrations:

4.6, 10, 21, 46 and 100 mg test item/L, and a control

Details on test conditions:

Surrounding Type
controlled environment room

Water temperature
21 °C

Light Regime
16 h light : 8 h dark

Light Intensity
450 Lux

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 31 mg/L

Remarks on result:

other: Test item concentration

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 21 mg/L

Remarks on result:

other: Lower 95 % confidence value; calculated as the geometrical mean value of the two concentrations with 0% and 100% immobility. 95% confidence value corresponds to the next lower and next higher test concentrations.

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 46 mg/L

Remarks on result:

other: Upper 95 % confidence value; calculated as the geometrical mean value of the two concentrations with 0% and 100% immobility. 95% confidence value corresponds to the next lower and next higher test concentrations.

Effect concentrations 4

Duration:

24 h

Dose descriptor:

other: EC 0

Effect conc.:

ca. 21 mg/L

Remarks on result:

other: Test item concentration

Effect concentrations 5

Duration:

24 h

Dose descriptor:

other: EC 100

Effect conc.:

ca. 46 mg/L

Remarks on result:

other: Test item concentration

Effect concentrations 6

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 14.5 mg/L

Remarks on result:

other: Test item concentration; calculated as the geometrical mean value of the two concentrations with 0% and 100% immobility. 95% confidence value corresponds to the next lower and next higher test concentrations.

Effect concentrations 7

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 10 mg/L

Remarks on result:

other: Lower 95 % confidence value; calculated as the geometrical mean value of the two concentrations with 0% and 100% immobility. 95% confidence value corresponds to the next lower and next higher test concentrations.

Effect concentrations 8

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 21 mg/L

Remarks on result:

other: Uper 95 % confidence value; calculated as the geometrical mean value of the two concentrations with 0% and 100% immobility. 95% confidence value corresponds to the next lower and next higher test concentrations.

Effect concentrations 9

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 10 mg/L

Remarks on result:

other: Test item concentration

Effect concentrations 10

Duration:

48 h

Dose descriptor:

other: EC 0

Effect conc.:

ca. 10 mg/L

Remarks on result:

other: Test item concentration

Effect concentrations 11

Duration:

48 h

Dose descriptor:

other: EC 100

Effect conc.:

ca. 21 mg/L

Remarks on result:

other: Test item concentration

Details on results:

Signs of Intoxication after 24 hours
After 24 hours in the control and in the test concentrations up to 21 mg test item/L no mortality or immobilization of the test animals was observed (see Table 1 and Figure 1). At the two highest test concentrations of 46 and 100 mg/L all Daphnia looked pale and were largely immobile. However, no Daphnia was dead at these test concentrations.

Results alter 24 hour
The 24-hour EC 50 of the test item was calculated to be 31 mg test item/L with 95 % confidence limits from 21 to 46 mg/L (as the geometrical mean value of the two con¬centrations with 0 % and 100 % immobility).
The 24-hour EC 0 was 21 mg test item/L, the 24-hour EC 100 amounted to 46 mg test item/L.

Signs of Intoxication after 48 hours
After 48 hours of exposure the toxicity of the test item to Daphnia magna had increased. In the control 2 Daphnia were immobile. However according to the test guidelines this immobilization rate is tolerated in the control. At the test concentrations of 4.6 and 10 mg/L no immobility or mortality of the test animals or other signs of intoxication were determined during the test period of 48 hours.
At the concentrations of 21 to 100 mg/L the bodies of all Daphnia were swollen and their antenna stick together. Although all Daphnia were alive, they were largely immo¬bile. Therefore, these test concentrations were considered to be concentrations with 100 % effect.

Results after 48 hours
The 48-hour EC 50 was calculated to be 14.5 mg test item/L with 95 % confidence limits from 10 to 21 mg/L (as the geometrical mean value of the two concentrations with 0 % and 100 % immobility). The 48-hour EC 0 and the 48- hour NOEC (highest concentration tested without toxic effects after 48 hours) of Effortil-Rohbase were determined to be 10 mg test item/L, since no significant immobiliza¬tion rate and no other signs of intoxication were observed at the test animals up to and including this test concentra¬tion. The 48-hour EC 100 amounted to 21 mg test item/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

Title

Acute Toxicity of Effortil-Rohbase toDaphnia magnain a 48-hour Immobilization Test

Guidelines/Recommendations

—  Commission.Directive 92/69/EEC, Annex Part C, C.2: "AcuteToxicity forDaphnia",Official Journalof the European Com­munities No. L 383 A, dated December 29, 1992.

—  OECD Guideline for Testing of Chemicals, Section 2, No. 202:"Daphnia sp.,Acute Immobilisation Test and ReproductionTest", Part I, adopted April 04, 1984.

—  Additionally the recommendations of the EPA Guideline 712­C-96-114: OPPTS 850.1010, "Aquatic Invertebrate AcuteToxicity Test, Freshwater Daphnids" April 1996 were takeninto account.

Purpose

The influence of the test item Effortil-Rohbase an the mobilityrespectively survival ofDaphnia magnawas tested. YoungDaph­niawere exposed in a static test to the test item for 48 hours,added to water at a range of concentrations.

Test concentration

4.6, 10, 21, 46 and 100 mg test item/L, and a control

Biological Results

After 24 hours at the concentrations of 46 and 100 mg/L allDaphnialooked pale and were largely immobile. However, noDaphniawas dead at these test concentrations. After 48 hours at the concentrations of 21 to 100 mg/L the bodies of all Daphnia were swollen and their antenna stick together. Although all Daphnia were alive, they were largely immobile. Therefore, thesetest concentrations were considered to be concentrations with 100 % effect.