1,1,3-trimethylindan-4-amine

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 12, 2020 to December 07, 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine

EC Number:

838-724-1

Cas Number:

94568-76-0

Molecular formula:

C12H17N

IUPAC Name:

1,1,3-trimethyl-2,3-dihydro-1H-inden-4-amine

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Sampling: Duplicate samples from the freshly prepared test media of all test concentrationsand the control were taken at the start of the test. For the determination of the stability of thetest item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the control were collected at the end of the test (after 48 hours) by pouring together the contents of the test beakers of each treatment.All samples were diluted by a factor of 2 with acetonitrile.Additional samples of the control and the dilution solvent were taken at test start and test end without any sample treatment.
Storage: All samples were stored in a freezer (≤ - 20 °C), protected from light, until analysis was performed. Afterwards the samples were again stored deep frozen and will be kept stored up to the date of the final report.

Test solutions

Vehicle:

no

Details on test solutions:

The test medium of the highest test concentration of nominal 100 mg test item/L was prepared by dissolving 104.2 mg test item into 1042 mL test water by intense stirring for 120 minutes and ultrasonic treatment for 30 minutes. Adequate volumes of this test medium were diluted with test water to prepare the test media of the other desired test concentrations.
The test media were prepared just before introduction of the daphnids (= start of the test).

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Straus), clone 5
Age at Test Start: From 4.00 to 20.75 hours old
Origin: The daphnids introduced in the test were taken from ibacon's in-house laboratory culture.
Breeding Conditions: The daphnidswere bred in the laboratories of ibacon under similar temperature and light conditions as used in the test. The cultivation of the parental daphnids was performed in Elendt M4 medium. The test organisms were not first brood progeny. The daphnids in the stock culture were fed at least on all working days with green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.
Acclimatisation: Was not necessary, since the test was performed in the same medium as the culturing .

Study design

Test type:

static

Water media type:

other: reconsituted water

Remarks:

Elendt "M4"

Total exposure duration:

48 h

Test conditions

Hardness:

2.5 mmol/L (= 250 mg/L) as CaCO3

Test temperature:

19.6 to 20.0 °C at test start
19.8 to 20.1 °C at test end

pH:

6.9 at test start;
7.0 to 7.2 at test end;
and thus the pH-value did not vary by more than 1.5 units

Dissolved oxygen:

8.9 to 9.1 mg/L at test start
8.5 to 8.7 mg/L at test end

Nominal and measured concentrations:

nominal concnetrations:
100, 45.5, 20.7, 9.4 and 4.3 mg test item/L (spacing factor 2.2) and a control

measured concnetrations:
Mean Recovery in the Test Samples: Freshly prepared: 102% (n = 10, RSD 2%)
Aged test media: 97% (n = 10, RSD 3%)

Details on test conditions:

Test Unit: Glass beakers of 100 mL volume containing approximately 60 mL of test medium. The test vessels were covered with a lid to reduce the loss of water due to evaporation and to avoid the entry of dust into the solutions.

Introduction of Daphnids: 20 daphnids per control and test concentration, divided into 4 groups of 5 animals, each group in one test vessel.
Replicates: The test was performed with four replicates per treatment group. Exposure Time: 48 hours
Test Procedure: A static test was performed.
Feeding: None

Reconstituted Water(Elendt "M4"):
Analytical grade salts and additives were added at the following nominal concentrations in deionised water:
Main Compounds: CaCl2·2 H2O (293.80 mg/L), MgSO4·7 H2O (123.30 mg/L), KCl (5.80 mg/L), NaHCO3 (64.80 mg/L), Na2SiO3·9 H2O (10.00 mg/L), NaNO3 (0.27 mg/L), KH2PO4 (0.14 mg/L), K2HPO4 (0.18 mg/L),
Trace Elements: H3BO3 (2860 μg/L), MnCl2·4 H2O (361 μg/L), LiCl (306 μg/L), RbCl (71 μg/L), SrCl2·6 H2O (152 μg/L), NaBr (16 μg/L), Na2MoO4·2 H2O (63 μg/L), CuCl2·2 H2O (17 μg/L), ZnCl2 (13 μg/L), CoCl2·6 H2O (10 μg/L), KI (3.3 μg/L), Na2SeO3 (2.2 μg/L), NH4VO3 (0.6 μg/L), Na2EDTA·2H2O (2.5 mg/L), FeSO4·7 H2O (1.0 mg/L)
Vitamins: Thiamine HCl (75.0 μg/L), Cyanocobalamin (B12) (1.0 μg/L), Biotin (B6) (0.75 μg/L)

Photo period:
Light Regime: 16 h light : 8 h dark
Light Intensity:The light intensity was 420 to 621 lux (measured once during the test).

Reference substance (positive control):

yes

Remarks:

For the evaluation of the quality of the Daphniaclone and the consistency of the experimental conditions, the reference item potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

24 h

Dose descriptor:

LOEC

Effect conc.:

45.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

20.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

24 h

Dose descriptor:

EC10

Effect conc.:

45.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 5

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

9.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

4.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 7

Key result

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

8.64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 8

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

14 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

After 48 hours of exposure no immobilisation of the test animals was observed in the control and the test item concentration of 4.3mg test item/L. At the concentration of 9.4mg test item/L, 3daphnids were immobile.
17 immobile daphnids were observed at the test itemconcentration of 20.7 mg test item/L. At the highest test item concentrations of 45.5 and 100 mg test item/L, respectively, all daphnids were immobile.

Results with reference substance (positive control):

The results of the most recent test with the Reference Item Potassium dichromate performed in January 2020 indicate that the sensitivity of the daphnids was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).
EC50 24 h: 1.163 mg test item/L
EC50 48 h: 0.986 mg test item/L

Reported statistics and error estimates:

The 24-hour and 48-hour EC50, EC20 and EC10 and the 95 % confidence limits were calculated by probit analysis.The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data. The software used to perform the statistical analysis was ToxRat Professional, Version 3.3.0, ToxRat Solutions GmbH.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Control Immobilisation Rate was 0 % and no daphnid showed signs of disease or stress Dissolved Oxygen Concentration was ≥ 8.5 mg O2/L in in all treatment groups at the end of the test;

Conclusions:

The toxic effect of the test item BCS-AF93710 to Daphnia magnawas assessed in a static concentration-response test. The 48-hour NOEC was determined to be 4.3 mg test item/L. The 48-hour LOEC was determined to be 9.4 mg test item/L and the 48-hour EC50 value was calculated to be 14.0 mg test item/L. The initial concentrations and the maintenance of the exposure
concentrations during the test were verified in the analytical part. All reported results refer to nominal values since the concentrations of the test item were within ± 20% of the nominal concentrations during the test

Executive summary:

Title: BCS-AF93710: Acute Toxicity to Daphnia magnain a Static 48-hour Immobilisation TestPurpose: The purpose of this study was to determine the influence of the test item BCS-AF93710 on the mobility of Daphnia magna. For this purpose, young daphnids (< 24 hours old) were exposed in a static test to various concentrations under defined conditions for 48 hours. The recorded effects were the mobility of the daphnids after 24 and 48 hours. The test method and the test species Daphnia magnaare recommended by the test guidelines.The purpose of the analytical part of this study wasto verify the concentrations of the test item in the test medium

Test Species: Daphnia magna, clone 5; 4.00 to 20.75 hours old. Source: The daphnids introduced in the test were taken from ibacon's in-house laboratory culture.Test Design: This study encompassed 6 treatment groups (5 dose rates of the test item and a control) each containing 20 individuals. The mobility of thedaphnids was determined in a static 48-hour test by visual observation after 24 and 48 hours.

Endpoints: Number of immobile organisms after 24 and 48 hours

Test Concentrations: 100, 45.5, 20.7, 9.4 and 4.3 mg test item/L (spacing factor 2.2) and a control.

Test Conditions:Water temperature: 19.6 to 20.1 °C; pH value: 6.9 to 7.2; dissolved oxygen concentration: 8.5 to 9.1 mg/L; photoperiod: 16 h light - 8 h dark; light intensity: 420 to 621 lux; and thus were within the ranges requested by guideline OECD 202

Results

Biological Test Results: After 48 hours of exposure no immobilisation of the test animals was observed in the control and the test item concentration of 4.3mg test item/L. At the concentration of 9.4mg test item/L, 3daphnids were immobile. 17 immobile daphnids were observed at thetest itemconcentration of 20.7 mg test item/L. At the highest test item concentrations of 45.5 and 100 mg test item/L, respectively, all daphnids were immobile.

Analytical test results: The quantification of the test item BCS-AF93710 in the test samples was performed using liquid chromatography with UV detection.At the start of the test 102 % of the nominal test concentrations were found (average of all test concentrations). After 48 hours test duration, 97 % of the nominal value was determined (average of all test concentrations). During the test the daphnids were exposed to a mean of 99 % of nominal.

Conclusion:The toxic effect of the test item BCS-AF93710 to Daphnia magna was assessed in a static concentration-response test. The 48-hour NOEC was determined to be 4.3 mg test item/L. The 48-hour LOEC was determined to be 9.4mg test item/L and the 48-hour EC50 value was calculated to be 14.0 mg test item/L. The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. All reported results refer to nominal values since the concentrations of the test item were within ± 20% of the nominal concentrations during the test