Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.

REACH

(2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid

EC number: 860-352-3 | CAS number: 1610350-91-8

Life Cycle description
Uses advised against

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference

Endpoint:: toxicity to aquatic algae and cyanobacteria
Type of information:: experimental study
Adequacy of study:: key study
Study period:: 2020-06-04 to 2020-09-01
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: guideline study
Qualifier:: according to guideline
Guideline:: EU Method C.3 (Algal Inhibition test)
Version / remarks:: August 24, 2009
Deviations:: no
Qualifier:: according to guideline
Guideline:: OECD Guideline 201 (Alga, Growth Inhibition Test)
Version / remarks:: adopted March 23, 2006, corrected July 28, 2011
Deviations:: no
GLP compliance:: yes (incl. QA statement)
Analytical monitoring:: yes
Details on sampling:: The samples were taken from the biological phase of the study. Duplicate samples from the freshly prepared test media (containing algae) of all test concentrations and from the control were taken at the start of the test. For the determination of the stability of the test 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 (containing algae) were taken at the end of the test (after the 72 hours test period) by pouring together the contents of the test beakers of each treatment. All samples remained untreated. All samples were stored in a freezer (≤ 20 °C), protected from light until analysis was performed.
Vehicle:: no
Details on test solutions:: PREPARATION AND APPLICATION OF TEST SOLUTION
The test medium of the highest test concentration of nominal 100 mg test item/L was prepared by dissolving 94.5 mg test item into 945 mL test water by intense stirring for 105 minutes and ultrasonication for 15 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 algae (= start of the test). The test item was slightly observable at the surface within the first 48 hours.
Test organisms (species):: Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
Details on test organisms:: TEST ORGANISM
- Common name: green algae
- Strain: 61.81 SAG
- Source: Collection of Agal Cultures, 37073 Göttingen, Germany.
Test type:: static
Water media type:: freshwater
Limit test:: no
Total exposure duration:: 72 h
Hardness:: 0.24 mmol/L (= 24 mg/L) as CaCO3
Test temperature:: 20.8 - 22.2 °C
pH:: 8.0 - 8.7 (in the control group);
7.8 - 8.7 (in the treatment group)
Nominal and measured concentrations:: Nominal Conc.: 100, 50, 25, 12.5, 6.25 mg test item/L;
Measured conc.: mean of 94 % of nominal.
Details on test conditions:: TEST SYSTEM
- Test vessel: Erlenmeyer flasks of 50 mL volume
- Type: closed
- Initial cells density: 5000 algal cells /mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: OECD medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity: 5133 lux (4480 to 5590 lux)

EFFECT PARAMETERS MEASURED:
- Determination of cell concentrations: spectrophotometer

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

RANGE FINDING STUDY
- Test concentrations: 100, 50, 25, 12.5, 6.25 mg test item/L and a control.
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):: yes
Remarks:: Potassium dichromate
: Key result
Duration:: 72 h
Dose descriptor:: EC50
Effect conc.:: > 100 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: growth rate
Duration:: 72 h
Dose descriptor:: EC50
Effect conc.:: > 100 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: biomass
: Key result
Duration:: 72 h
Dose descriptor:: EC10
Effect conc.:: > 100 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: growth rate
Duration:: 72 h
Dose descriptor:: EC10
Effect conc.:: 44.3 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: biomass
Duration:: 72 h
Dose descriptor:: NOEC
Effect conc.:: 50 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: growth rate
Duration:: 72 h
Dose descriptor:: NOEC
Effect conc.:: 25 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: biomass
Duration:: 72 h
Dose descriptor:: LOEC
Effect conc.:: 100 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: growth rate
Duration:: 72 h
Dose descriptor:: LOEC
Effect conc.:: 50 mg/L
Nominal / measured:: nominal
Conc. based on:: test mat.
Basis for effect:: biomass
Details on results:: The microscopic examination of the shape of the algal cells after 72 hours of test duration did not show any difference between the algae that had been growing up to a nominal test concentration of 100 mg test item/L and the algal cells in the control. Thus, the shape of the algal cells was not obviously affected up to this test concentration, the highest concentration tested.
Results with reference substance (positive control):: - Results with reference substance valid? Yes
For the evaluation of the reliability of the test system and the experimental conditions Potassium dichromate is tested at least twice a year. The last study with the reference item Potassium dichromate was performed in January 2020 and the following results were obtained:
The 72h ErC50: 0.858 mg/L, (95 % confidence limits: 0.811 - 0.919 mg/L)
The 72h EyC50: 0.470 mg/L, (95 % confidence limits: 0.450 - 0.488 mg/L)
Validity criteria fulfilled:: yes
Conclusions:: The effect of the test item on algal growth was assessed using the freshwater green alga Pseudokirchneriella subcapitata according to OECD TG 201 showed the following results: The 72-hour EyC50 was calculated to be > 100 mg test item/L and the 72-hour ErC50 value was calculated to be > 100 mg test item/L. The 72-hour EyC10 was calculated to be 44.3 mg test item/L and the 72-hour ErC10 value was calculated to be > 100 mg test item/L. The 72-hour NOEyC was determined to be 25 mg test item/L and the associated 72-hour LOEyC was 50 mg test item/L. The 72-hour NOErC was determined to be 50 mg test item/L and the associated 72-hour LOErC was 100 mg test item/L. No abnormal appearance of the algal cells was observed during the experiment.
Executive summary:: The acute toxicity of the test item was investigated in a GLP-study according to OECD test guideline 201 using unicellular freshwater green alga Pseudokirchneriella subcapitata. For this purpose, exponentially growing cultures of this unicellular green algal species were exposed to various concentrations (100, 50, 25, 12.5, 6.25 mg test item/L (spacing factor 2)) of the test item under defined conditions. The inhibition of growth in relation to control cultures was determined over a test period of 72 hours, and thus over several algal generations. The test method and the test species Pseudokirchneriella subcapitata are recommended by the OECD guideline. The purpose of the analytical part of this study was to verify the concentrations of the test item in the test medium. This study encompassed 6 treatment groups (5 dose rates of the test item and a control) with three replicates per test concentration and six replicates for the control. At test start 50 mL of the test media were inoculated with nominal 5000 algal cells per mL test medium and defined volumes of the algal suspensions were sampled after 24, 48 and 72 for determination of cell densities by spectrophotometric measurement. The quantification of the test item in the test samples was performed using high performance liquid chromatography (HPLC) with UV. The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. The recoveries at the test start in case of all concentrations are above 80% and this confirmed that the test item was dosed correctly. During the test, the algae were exposed to a mean concentration of 94 % of the nominal concentration. All reported results refer to nominal values. Thus, the effect of the test item on freshwater green alga Pseudokirchneriella subcapitata according to OECD TG 201 showed the following results: The 72-hour E_yC₅₀ was calculated to be > 100 mg test item/L and the 72-hour E_rC₅₀ value was calculated to be > 100 mg test item/L. The 72-hour E_yC₁₀ was calculated to be 44.3 mg test item/L and the 72-hour E_rC₁₀ value was calculated to be > 100 mg test item/L. The 72-hour NOE_yC was determined to be 25 mg test item/L and the associated 72-hour LOE_yC was 50 mg test item/L. The 72-hour NOE_rC was determined to be 50 mg test item/L and the associated 72-hour LOE_rC was 100 mg test item/L. No abnormal appearance of the algal cells was observed during the experiment.

Description of key information

The effect of the test item on algal growth was assessed using the freshwater green alga Pseudokirchneriella subcapitata according to OECD TG 201 showed the following results: The 72-hour E_yC₅₀ was calculated to be > 100 mg test item/L and the 72-hour E_rC₅₀ value was calculated to be > 100 mg test item/L. The 72-hour E_yC₁₀ was calculated to be 44.3 mg test item/L and the 72-hour E_rC₁₀ value was calculated to be > 100 mg test item/L. The 72-hour NOE_yC was determined to be 25 mg test item/L and the associated 72-hour LOE_yC was 50 mg test item/L. The 72-hour NOE_rC was determined to be 50 mg test item/L and the associated 72-hour LOE_rC was 100 mg test item/L. No abnormal appearance of the algal cells was observed during the experiment (reference 6.1.5 -1).

Key value for chemical safety assessment

Additional information

The acute toxicity of the test item was investigated in a GLP-study according to OECD test guideline 201 using unicellular freshwater green alga Pseudokirchneriella subcapitata. For this purpose, exponentially growing cultures of this unicellular green algal species were exposed to various concentrations (100, 50, 25, 12.5, 6.25 mg test item/L (spacing factor 2)) of the test item under defined conditions. The inhibition of growth in relation to control cultures was determined over a test period of 72 hours, and thus over several algal generations. The test method and the test species Pseudokirchneriella subcapitata are recommended by the OECD guideline. The purpose of the analytical part of this study was to verify the concentrations of the test item in the test medium. This study encompassed 6 treatment groups (5 dose rates of the test item and a control) with three replicates per test concentration and six replicates for the control. At test start 50 mL of the test media were inoculated with nominal 5000 algal cells per mL test medium and defined volumes of the algal suspensions were sampled after 24, 48 and 72 for determination of cell densities by spectrophotometric measurement. The quantification of the test item in the test samples was performed using high performance liquid chromatography (HPLC) with UV. The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. The recoveries at the test start in case of all concentrations are above 80% and this confirmed that the test item was dosed correctly. During the test, the algae were exposed to a mean concentration of 94 % of the nominal concentration. All reported results refer to nominal values. Thus, the effect of the test item on freshwater green alga Pseudokirchneriella subcapitata according to OECD TG 201 showed the following results: The 72-hour E_yC₅₀ was calculated to be > 100 mg test item/L and the 72-hour E_rC₅₀ value was calculated to be > 100 mg test item/L. The 72-hour E_yC₁₀ was calculated to be 44.3 mg test item/L and the 72-hour E_rC₁₀ value was calculated to be > 100 mg test item/L. The 72-hour NOE_yC was determined to be 25 mg test item/L and the associated 72-hour LOE_yC was 50 mg test item/L. The 72-hour NOE_rC was determined to be 50 mg test item/L and the associated 72-hour LOE_rC was 100 mg test item/L. No abnormal appearance of the algal cells was observed during the experiment.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Parameter	Yield [mg test item/L]	Growth rate [mg test item/L]
72-hour EC₅₀	> 100	>100
95 % conf. interval	n.d.	n.d.
72-hour EC₂₀	> 100	>100
95 % conf. interval	n.d.	n.d.
72-hour EC₁₀	44.3	>100
95 % conf. interval	n.d.	n.d.
72-hour NOEC	25	50
72-hour LOEC	50	100

Sample Description [mg test item/L]	% of nominal¹	RSD [%]	n
Control	n.a.	n.a.	4
6.25	109	2	2
12.5	85	19	4
25	93	10	4
50	94	5	4
100	98	3	4

Nominal concentration [mg test item/L]	Flask No.	Density of algal cells [10000/mL] after
Nominal concentration [mg test item/L]	Flask No.	24 hours	48 hours	72 hours
Control	1	1.866	15.082	76.430
	2	1.658	14.254	76.650
	3	1.658	15.496	75.110
	4	2.074	15.496	77.971
	5	1.866	16.117	77.530
	6	1.658	15.496	67.849
	m	1.797	15.323	75.257
	s	0.170	0.620	3.762
6.25	1	2.282	15.910	77.310
	2	2.282	14.668	70.709
	3	2.282	15.496	71.809
	m	2.282	15.358	73.276
	s	0.000	0.632	3.537
12.5	1	2.490	15.703	83.912
	2	2.490	14.461	73.790
	3	2.282	15.496	74.010
	m	2.420	15.220	77.237
	s	0.120	0.665	5.781
25	1	2.282	14.254	70.489
	2	2.074	13.219	71.149
	3	2.074	14.047	65.648
	m	2.143	13.840	69.096
	s	0.120	0.548	3.004
50	1	1.866	12.805	65.428
	2	2.074	12.184	57.947
	3	2.074	13.840	74.670
	m	2.005	12.943	66.015
	s	0.120	0.837	8.377
100	1	2.074	13.840	64.548
	2	2.282	16.738	75.330
	3	2.074	12.184	52.886
	m	2.143	14.254	64.255
	s	0.120	2.305	11.225

Nominal concentration [mg test item/L]	Flask No.	Yield y [10000 cells/mL] after
Nominal concentration [mg test item/L]	Flask No.	24 hours	48 hours	72 hours
Control	1	1.366	14.582	75.930
	2	1.158	13.754	76.150
	3	1.158	14.996	74.610
	4	1.574	14.996	77.471
	5	1.366	15.617	77.030
	6	1.158	14.996	67.349
	m	1.297	14.823	74.757
	s	0.170	0.620	3.762
6.25	1	1.782	15.410	76.810
	2	1.782	14.168	70.209
	3	1.782	14.996	71.309
	m	1.782	14.858	72.776
	s	0.000	0.632	3.537
12.5	1	1.990	15.203	83.412
	2	1.990	13.961	73.290
	3	1.782	14.996	73.510
	m	1.920	14.720	76.737
	s	0.120	0.665	5.781
25	1	1.782	13.754	69.989
	2	1.574	12.719	70.649
	3	1.574	13.547	65.148
	m	1.643	13.340	68.596
	s	0.120	0.548	3.004
50	1	1.366	12.305	64.928
	2	1.574	11.684	57.447
	3	1.574	13.340	74.170
	m	1.505	12.443	65.515
	s	0.120	0.837	8.377
100	1	1.574	13.340	64.048
	2	1.782	16.238	74.830
	3	1.574	11.684	52.386
	m	1.643	13.754	63.755
	s	0.120	2.305	11.225

Nominal concentration [mg test item/L]	Flask No.	Growth rates u [1/day] after
Nominal concentration [mg test item/L]	Flask No.	0 - 24 hours	0 - 48 hours	0 - 72 hours
Control	1	1.317	1.703	1.677
	2	1.199	1.675	1.677
	3	1.199	1.717	1.671
	4	1.423	1.717	1.683
	5	1.317	1.737	1.681
	6	1.199	1.717	1.637
	m	1.276	1.711	1.671
	s	0.092	0.021	0.017
6.25	1	1.518	1.730	1.680
	2	1.518	1.689	1.651
	3	1.518	1.717	1.656
	m	1.518	1.712	1.662
	s	0.000	0.021	0.016
12.5	1	1.605	1.723	1.708
	2	1.605	1.682	1.665
	3	1.518	1.717	1.666
	m	1.576	1.708	1.679
	s	0.050	0.022	0.024
25	1	1.518	1.675	1.650
	2	1.423	1.637	1.653
	3	1.423	1.668	1.626
	m	1.454	1.660	1.643
	s	0.055	0.020	0.015
50	1	1.317	1.621	1.625
	2	1.423	1.597	1.584
	3	1.423	1.660	1.669
	m	1.387	1.626	1.626
	s	0.061	0.032	0.042
100	1	1.423	1.660	1.620
	2	1.518	1.755	1.672
	3	1.423	1.597	1.554
	m	1.454	1.671	1.615
	s	0.055	0.080	0.059

Nominal concentration [mg test item/L]	Yields y [10000cells/mL] and % inhibition of y
	0- 24 hours		0 - 4 8 hours		0 - 72 hours
	Y	%	y	%	y	%
Control	1.297	-	14.823	-	74.757	-
6.25	1.782	-37.4	14.858	-0.2	72.776	2.6
12.5	1.920	-48.1	14.720	0.7	76.737	-2.6
25	1.643	-26.7	13.340	10.0	* 68.596	8.2
50	1.505	-16.0	12.443	16.1	* 65.515	12.4 *
100	1.643	-26.7	13.754	7.2	* 63.755	14.7 *

	Growth rates p. [1/day] and % inhibition of µ
Nominal concentration	0-24 hours		0 - 4 8 hours		0-	72 hours
[mgtest item/L]	u	%	1	%	M-	%
Control	1.276	-	1.711	-	1.671	-
6.25	1.518	-19.0	1.712	-0.1	1.662	0.5
12.5	1.576	-23.6	1.708	0.2	1.679	-0.5
25	1.454	-14.0	1.660	3.0	1.643	1.7
50	1.387	-8.8	1.626	5.0	* 1.626	2.7
100	1.454	-14.0	1.671	2.3	1.615	3.3 *

Nominal concentration	Microscopic observations of algal cells
[mg test item/L]	0 hours	72 hours
6.25	0	0
12.5	0	0
25	0	0
50	0	0
100	0	0

Sample Description [mg test item/L]	Sampling Age		Concentration found		Concentration calculated [mgtest item/L]¹	Concentration nominal [mgtest item/L]¹	% of nominal¹
Sample Description [mg test item/L]	day	[h]	[mg test item/L]¹	D.F.	Concentration calculated [mgtest item/L]¹	Concentration nominal [mgtest item/L]¹	% of nominal¹
Control	0	0	<LOD	2	n.a.	0.000	n.a.
Control	0	0	<LOD	2	n.a.	0.000	n.a.
Control	3	72	<LOD	2	n.a.	0.000	n.a.
Control	3	72	<LOD	2	n.a.	0.000	n.a.
6.25	0	0	3.468	2	6.936	6.250	111
6.25	0	0	3.350	2	6.700	6.250	107
6.25	3	72	1.900	2	3.800	6.250	<LOQ
6.25	3	72	1.895	2	3.791	6.250	<LOQ
						mean value (n=2):	109
						RSD (n=2):	2
12.5	0	0	6.170	2	12.340	12.500	99
12.5	0	0	6.202	2	12.404	12.500	99
12.5	3	72	4.580	2	9.160	12.500	73
12.5	3	72	4.340	2	8.680	12.500	69
						mean value (n=4):	85
						RSD (n=4):	19
25	0	0	12.486	2	24.973	25.000	100
25	0	0	12.639	2	25.278	25.000	101
25	3	72	10.430	2	20.860	25.000	83
25	3	72	10.761	2	21.523	25.000	86
						mean value (n=4):	93
						RSD (n=4):	10
50	0	0	24.648	2	49.295	50.000	99
50	0	0	24.433	2	48.866	50.000	98
50	3	72	22.429	2	44.858	50.000	90
50	3	72	22.515	2	45.031	50.000	90
						mean value (n=4):	94
						RSD (n=4):	5
100	0	0	49.883	2	99.765	100.000	100
100	0	0	50.632	2	101.264	100.000	101
100	3	72	48.089	2	96.179	100.000	96
100	3	72	48.281	2	96.562	100.000	97

						mean value (n=4):	98
						RSD (n=4):	3
overall mean value (n=18):							94
RSD (n=18):							11