Amines, di-C16-18-alkylmethyl

Toxicity to aquatic algae and cyanobacteria

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

effects on growth of green algae

Data waiving:

other justification

Justification for data waiving:

other:

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

Version / remarks:

2016

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Version / remarks:

2011

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification: Amines, di-C16-C18-alkyl methyl
Abbreviation: DAM M2HT

Chemical name: Amines, di-C16-C18-alkyl methyl

IUPAC name: N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even
numbered)-alkyl-1-amine
CAS Number: 1227096-04-9
EC Number: 627-132-7
Batch: 100002434128
Purity: 100% UVCB
Water content: 0.03%
Physical state / Appearance: White solid paste
Expiry date: 16 February 2025
Storage conditions: Room temperature in the dark

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

Test organism: Raphidocelis subcapitata strain CCAP 278/4 were obtained from the Culture Collection of Algae and Protozoa (CCAP), SAMS Research Services Ltd, Scottish Marine Institute, Oban, Argyll, Scotland.

Test type:

static

Water media type:

freshwater

Remarks:

OECD TG 201 medium

Limit test:

no

Total exposure duration:

72 h

Reference 2

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1990-07-31 to 1990-09-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

no data

Vehicle:

no

Details on test solutions:

A stock suspension of 1020 g/L was prepared by dispersing the test substance in deionized water (50°C) with an ultrasonic processor.
The selected test concentrations were prepared by dilution of this stock suspension in the inoculated test medium.

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM
- Strain: ATCC 22662

ACCLIMATION
- Conditions: maintained on mineral salts agar slants in the light at room temperature.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Hardness:

no data

Test temperature:

22.5 - 23.0°C

pH:

6.8 - 6.9 at the beginning of the test and 7.2 - 8.3 at the end of the test

Dissolved oxygen:

no data

Salinity:

no data

Nominal and measured concentrations:

Nominal concentrations: 0.01 - 0.03 - 0.09 - 0.27 - 0.81 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-ml erlenmeyers containing 40 ml of mineral salts medium.

TEST MEDIUM / WATER PARAMETERS
- Conductivity: < 5 µS/cm
- Copper: < 0.01 mg/L

OTHER TEST CONDITIONS
- Illumination: continuous uniform illumination, provided in the spectral range of 400 to 700 nm.
- Light intensity: in the range of 6000 to 10000 lux.
- Continuous rotation of the culture flasks at 100 rpm to prevent sedimentation of the algae.

TEST CONCENTRATIONS
- Range finding study: in the range finding test, at nominal concentrations of 0.1 - 1 - 10 and 100 mg/L, growth of the algae is inhibited.

Reference substance (positive control):

yes

Remarks:

potassium dichromate, purity 95%

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

0.12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Remarks on result:

other: 95% CL = 0.10 - 0.14 mg/L

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

0.05 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Remarks on result:

other: 95% CL = 0.04 - 0.06 mg/L

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

0.01 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Details on results:

Cell concentrations were determined spectrophotometrically.

Results with reference substance (positive control):

potassium dichromate: ErC50 = 0.79 mg/L and EbC50 = 0.20 mg/L

Validity criteria fulfilled:

yes

Conclusions:

Validity: the test is valid.
- ErC50 and EbC50 of the reference compound, potassium dichromate (0.79 and 0.20 mg/L respectively).
- Increase of the extinction of the control by a factor 98 (must be at least a 16 fold increase).
- Deviation of no more than 1.5 pH unit.

Deviations:
- 1 minnor deviation: the KH2PO4 and NaHCO3 concentrations in the test medium were increased to 160 and 100 mg/L, respectively, to maintain a constant pH.

Executive summary:

Acute toxicity of Amines, bis(hydrogenated tallow alkyl) methyl to Selenastrum capricornutum has been investigated through OECD Guideline 201.

Selenastrum capricornutum were exposed for 72 hours to a solution of Amines, bis(hydrogenated tallow alkyl) methyl

at different nominal concentrations of 0.01 - 0.03 - 0.09 - 0.27 and 0.81 mg/L.

ErC 50-72h determined was of 0.12 mg/L, EbC50-72h of 0.05 and NOEC of 0.01 mg/L.

Validity criteria were fulfilled.

Key value for chemical safety assessment

EC50 for freshwater algae:

0.12 mg/L

EC10 or NOEC for freshwater algae:

0.01 mg/L

Additional information

Three references have been identified for assessing impact of N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine on algae. As for invertebrates, none of them are considered as Klimish 1 due to the absence of  analytical confirmation of the exposure concentrations. The one which has been retained followed the OECD 201 requirements and did not use solvent for solubilizing the test item. Being the most compliant, this test was identified as a key study (Kroon, 1990) and resulted in a 72h ErC50 for algae of 0.12 mg/L. 

A further algae study with Amines, C16-18-alkylmethyl is currently running and the proposed draft report is planned to receive the beginning of July 2023. The final report is expected to be available at the end of August 2023. 
This information will be submitted a little bit later based on ECHA communication/decision number CCH-D-2114585941-37-01/F.