Reaction mass of 2-amino-2-methyl-1-propanol hydrochlorid (3207-12-3) and 2-amino-2-methyl-1-propanol (124-68-5)

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:

from 2018-05-08 to 2018-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

(2-hydroxy-1,1-dimethylethyl)ammonium chloride

EC Number:

221-713-5

EC Name:

(2-hydroxy-1,1-dimethylethyl)ammonium chloride

Cas Number:

3207-12-3

Molecular formula:

C4H11NO.ClH

IUPAC Name:

1-hydroxy-2-methylpropan-2-aminium chloride

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

Due to complexity of test item, test concentration analysis was not possible.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solution was freshly prepared prior to exposure by weighing required quantity of test item in a beaker. A small volume of reconstituted water was added and mixed well using a glass rod. After the complete solubility of the test item, the stock solution was transferred into a measuring cylinder. A magnetic stirrer was used to maintain the homogeneity of the stock solution. The required test concentrations were prepared by dilution of stock solution with reconstituted water.
- Controls: Positive control performed with potassium dichromate and blank control performed with the test solutions without test substance.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Waterflea
- Strain: Straus
- Source: Environmental and Molecular Toxicology Division, Department of Zoology, Karnataka Uni
versity, Karnataka, India
- Feeding during test: no

ACCLIMATION
- Acclimation period: 48 hours prior to test
- Acclimation conditions: same as test conditions
- Type and amount of food: live algal cells (Pseudokirchneriella subcapitata)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

None

Post exposure observation period:

Not performed

Test conditions

Hardness:

140 to 250 mg/L (as CaCO3)

Test temperature:

18 to 22 °C

pH:

6.0 to 9.0

Salinity:

Not applicable

Nominal and measured concentrations:

- Nominal concentrations: of 0.6, 1.3, 2.8, 6.1, 13.4, 29.5 and 65 mg/L
- Measured concentrations: No concentrations were measured

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers
- Type: Open
- Volume: 50 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dilution water prepared according with OECD guideline
- Culture medium different from test medium: No
- Intervals of water quality measurement: Total hardness of the reconstituted water was analyzed prior to its use for exposure. Temperature, pH and dissolved oxygen was recorded at the beginning and at the end of the test in controls and in all the test substance concentrations.

OTHER TEST CONDITIONS
- Adjustment of pH:No
- Photoperiod: 16 hours of light and 8 hours dark cycle

EFFECT PARAMETERS MEASURED: Immobilisation rate of daphnids by exposing them to the test item for 48 h.

VEHICLE CONTROL PERFORMED: No

RANGE-FINDING STUDY
- Test concentrations: - Nominal concentrations of 0.0131, 0.131, 1.31, 13.10, 65.5 and 131 mg/L
- Results used to determine the conditions for the definitive study: During dose range finding study, no immobility was observed in control and in the tested concentrations of 0.013 mg/L during the 48 hour observation period. % immobility of 10, 20, 50, 80 and 100% was observed in the tested concentrations of 0.131, 1.31, 13.1, 65.5 and 131.0 mg/L (test concentrations calculated using the correction factor of 1.31) during the 48 hour observation period.
Based on results of the dose range finding study, the main study will be conducted at the concentrations of 0.6, 1.3, 2.8, 6.1, 13.4, 29.5 and 65 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 17.31 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence intervals: 9.156 to 32.737 mg/L

Details on results:

Based on the results of the experiment, it can be concluded that the 48 hour EC50 of the test item on Daphnia magna is determined to be 17.313 mg/L.

Results with reference substance (positive control):

The 48-hour EC50 of the reference substance potassium dichromate on Daphnia magna was determined to be 0.57 mg/L. The 48 hour EC50 of the reference substance was within the acceptance range of the guideline (0.50 - 2.12 mg/L) confirming the suitability of the test system.

Reported statistics and error estimates:

EC10, EC20 and EC50 was calculated, using the percent immobility data of 0, 15, 25, 30, 50 and 100 % obtained for respective test concentrations of 0.6, 1.3, 2.8, 6.1, 13.4, 29.5 and 65 mg/L. The statistical analysis was carried out using ToxRatPro Version 3.2.1, software.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of the experiment, it can be concluded that the 48 hour EC50 of the test item on Daphnia magna is determined to be 17.313 mg/L.

Executive summary:

In a static immobilization test Daphnia magna (< 24 h old) were exposed to the test item for 48 hours according the OECD Guideline No. 202 (1992).

Daphnids were exposed to the test item by aqueous exposure (treatment) under static condition. Daphnids were observed at 24 and 48 hours for signs of toxicity and immobility. Based on the results of the range finding study, the main study was conducted at the nominal test concentrations of 0.6, 1.3, 2.8, 6.1, 13.4, 29.5 and 65 mg/L. Due to the complexity of the test item, test concentration analysis was not possible. The 48-hour EC50 of the reference substance potassium dichromate on Daphnia magna was determined to be 0.57 mg/L. Thus, the 48 hour EC50 of the reference substance was within the acceptance range of the guideline (0.50 - 2.12 mg/L) confirming the suitability of the test system. In addition, dissolved oxygen concentration at the end of the test was 6.27 mg/L and the immobilization in the control group was 0 % at the termination of the test during main study, therefore the validity criteria were met. Based on the results of the experiment, the 48h-EC50 was determined to be 17.313 mg/L.