1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

May 1995

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Deviations:

yes

Remarks:

The reported study is a screening study, not conducted according to GLP and no chemical analysis performed. The screening report is missing information on culture conditions, use of reference substances etc.

GLP compliance:

no

Specific details on test material used for the study:

Betadet SHR
Batch number 7049

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

no

Details on test solutions:

The test material was directly dispersed in water and a100 mg/L stock solution was prepared.This stock was diluted with water to prepare the test media.

Test organisms (species):

Daphnia magna

Details on test organisms:

No details reported.

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 applicable

Hardness:

Not reported

Test temperature:

21°C

pH:

Not reported

Dissolved oxygen:

Not reported

Salinity:

Not applicable

Conductivity:

Not applicable

Nominal and measured concentrations:

Nominal exposure concentrations, 0 (control), 0.1, 0.6, 1.0, 3.0, 6.0, 10 and 30 mg/L.

Details on test conditions:

No details reported

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CI - 2.9 - 4.4 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 30 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

30 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

The 24h EC50 of Betadet SHR was observed to be >30 mg/L (the highest nominal concentration tested) and the 48 h EC50 was calculated to be 3.5 mg/L with a corresponding NOEC of 1.0 mg/L.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Analysis was performed according to the method described by Thompson, 1947 (Thompson, WR, 1947, Bact. Reviews (11, 115-145)

Daphnia observations

Nominal concentration (mg/L)	Cumulative immobilised Daphnia (initial population = 20)
	24 hours		48 hours
	Total	%	Total	%
Control	0	0	0	0
0.1	0	0	0	0
0.6	0	0	0	0
1.0	0	0	0	0
3.0	0	0	3	15
6.0	0	0	14	70
10	0	0	20	100
30	0	0	20	100

 

Validity criteria fulfilled:

not specified

Conclusions:

The 24h EC50 of Betadet SHR was observed to be >30 mg/L (the highest nominal concentration tested) and the 48 h EC50 was calculated to be 3.5 mg/L with a corresponding NOEC of 1.0 mg/L.

Executive summary:

The acute toxicity of Betadet SHR to Daphnia magna was determined in a static study carried out according to OECD test guideline 202 (1984). Daphnia magna were exposed to nominal test concentrations of 0 (control), 0.1, 0.3, 1.0, 3.0, 6.0, 10 and 30 mg/L for 48 hours. No analytical verification was performed therefore the results of the study are based in the nominal exposure concentrations. 

The 24h EC50 of Betadet SHR was observed to be >30 mg/L (the highest nominal concentration tested) and the 48 h EC50 was calculated to be 3.5 mg/L (95% CI of 2.9 - 4.4 mg/L) with a corresponding NOEC of 1.0 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25 november to 15 march 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed according to an international guideline and according to GLP. The validity criteria were fulfilled except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable during 48 hours. Thus, we can considered that in a short-tem study, the susbtance is also stable.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Complementary information on test material: aqueous solution at 43.5% w/w of active content (= surface-active fraction, i.e. alkylamidopropylhydroxysultaine).

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

A stock solution was prepared in order to obtain a concentration of 100 ppm (w/w).
The tested concentrations were prepared by dilution of the stock solution.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnid, water flea (Daphnia magna Strauss 1820
- Strain: IRCHA
- Source: Laboratoire Ecotoxicologie du C.R.I.T. /D
- Length at study initiation: the test animals paased a mesh size of 800 µm but were detained in 560 µm mesh size
- Feeding during test: no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 - 21°C

pH:

8.4 (see table 1)

Dissolved oxygen:

95-96 (see table 1)

Nominal and measured concentrations:

nominal concentrations : 2.2, 3.4, 5.0, 7.5, 11, 15, 22, 34 and 50 ppm (w/w)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: 250 mL Pyrex glass beakers, fill volume 100 mL
- Aeration: No
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
bidistilled water conductivity µS/cm
CaCl2 * 2 H2O: 0.297 g/L
MgCl2 * 6 H2O: 0.167 g/L
NaHCO3: 0.200 g/L
K2SO4: 0.026 g/L
(pH at 21 °C immediately before use: 8.0)
pH and dissolved oxygen were measured after the incuvbation period of 24 h


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: incubation in the dark

EFFECT PARAMETERS MEASURED: immobility after 24 h

TEST CONCENTRATIONS
- Range finding test : 0.1, 0.35, 1.0, 3.5, 10, 35 and 100 ppm (w/w)
- Definitive Test : 2.2, 3.4, 5.0, 7.5, 11, 15, 22, 34 and 50 ppm (w/w)

Reference substance (positive control):

yes

Remarks:

Potassium dichromate, CAS 7778-50-9, analytical grade

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% confidence limits = 7.5 - 11 mg/L

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Results with reference substance (positive control):

The test animals were sensible and a LD50 to potassium dichromate of 1.3 mg/L was obtained (details are reported in the annex of study report D 218).

Reported statistics and error estimates:

The LC50 was determined by the binomial method (original sofware of C.E. Stephan)

Table 1 - % immobilization at 24 and 48 hours

Initial concentrations mg/L *	Immobilization				O2	pH
	Number / 20		%
	24 h	48 h	24 h	48 h	48 h	48 h
Control	0	0	0	0	96	8.4
2.2	0	0	0	0	95	8.4
3.4	0	1	0	5	95	8.4
5.0	0	1	0	5	95	8.4
7.5	0	0	0	0	95	8.4
11	8	19	40	95	95	8.4
15	19	20	95	100	95	8.4
22	12	20	60	100	95	8.4
34	13	20	65	100	96	8.4
50	15	20	75	100	96	8.4

 

* in the report, expressed as ppm (w/w)

Validity criteria fulfilled:

yes

Remarks:

See "executive summary" and remarks remarks "Rationale for reliability incl. deficienties"

Conclusions:

The EC50-48h = 9.8 mg test item/L (95% C.L. 7.5-11 mg/L)

Executive summary:

Daphnids (Daphnia magna) were exposed to the test item in a dose response study according to the E.U. standards published on 19^thSeptember 1994. The study was thus conducted similar to EU C.2. The test animals were exposed to nominal concentrations of 2.2, 3.4, 5.0, 7.5, 11, 15, 22, 34 and 50 mg/L of the test item, reported as ppm (w/w). No analytical measurements of the tested concentrations was performed but due to the high solubility of the substance. No mortality was observed in the control. The temperature, pH and the oxygen in the medium were maintained in the range recommended by the guidance document.The EC₅₀of 9.3 mg test item/L (4.0 mg active ingredient/L) was derived by graphical means.The NOEC was estimated to be 2.2 mg test item/L.

According to the data, the validity criteria were fulfilled ex except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable during 48 hours. Thus, we can considered that in a short-tem study, the susbtance is also stable.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source substance, C12-18 AAPHS, has the same functional groups and general composition as the target C12-14 substance. The main variable resides in the alkyl chain distribution.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source chemical = C12-18 cocamidopropyl hydroxysultaine (EC 939-457-4).
Target chemical = C12-14 cocamidopropyl hydroxysultaine (EC 293-878-1).

3. ANALOGUE APPROACH JUSTIFICATION
Cf. attaced Read-Across Justification Document (§13 Assessment reports).

4. DATA MATRIX
Cf. attached Read-Across Justification Document (§13 Assessment reports).

Reason / purpose for cross-reference:

read-across source

Specific details on test material used for the study:

Complementary information on test material: aqueous solution at 43.5% w/w of active content (= surface-active fraction, i.e. alkylamidopropylhydroxysultaine) is being used as a read across for 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limits = 7.5-11 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Reported statistics and error estimates:

The LC50 was determined by the binomial method (original sofware of C.E. Stephan)

Table 1 - % immobilization at 24 and 48 hours

Initial concentrations mg/L *	Immobilization				O2	pH
	Number / 20		%
	24 h	48 h	24 h	48 h	48 h	48 h
Control	0	0	0	0	96	8.4
2.2	0	0	0	0	95	8.4
3.4	0	1	0	5	95	8.4
5.0	0	1	0	5	95	8.4
7.5	0	0	0	0	95	8.4
11	8	19	40	95	95	8.4
15	19	20	95	100	95	8.4
22	12	20	60	100	95	8.4
34	13	20	65	100	96	8.4
50	15	20	75	100	96	8.4

 

* in the report, expressed as ppm (w/w)

Validity criteria fulfilled:

yes

Conclusions:

The EC50-48h = 9.8 mg test item/L (95% C.L. 7.5-11 mg/L) (equivalent to 4.0 mg active ingredient/L).

Executive summary:

The acute toxicity of the target substance, C12 -14 cocamidopropyl hydroxysultaine (C12 -14 AAPHS), to Daphnia magna was estimated based on read-across from a study testing C12-18 cocamidopropyl hydroxysultaine (C12-18 AAPHS). Given that C12 -14 AAPHS and C12-18 AAPHS share the same functional groups and general composition, the main variable being alkyl chain distribution, C12-18 AAPHS was considered appropriate for the purposes of read-across to C12 -14 AAPHS.

Daphnids (Daphnia magna) were exposed to C12-18 AAPHS in a dose response study according to the E.U. standards published on 19th September 1994. The study was thus conducted similar to EU C.2. The test animals were exposed to nominal concentrations of 2.2, 3.4, 5.0, 7.5, 11, 15, 22, 34 and 50 mg/L of the test item, reported as ppm (w/w). No analytical measurements of the tested concentrations was performed but due to the high solubility of the substance. No mortality was observed in the control. The temperature, pH and the oxygen in the medium were maintained in the range recommended by the guidance document. According to the data, the validity criteria were fulfilled except the lack of data relating to the analytical monitoring showing that the concentrations of the test item were maintained during the test. However, the test has been performed under semi-static conditions and according to the long-term toxicity to Daphnia, the substance is stable during 48 hours. Thus, we can consider that in a short-term study, the substance is also stable.

The 48 h EC50 of 9.3 mg test item/L (4.0 mg C12-18 AAPHS /L) was derived by graphical means. The corresponding NOEC was estimated to be 2.2 mg test item/L. This endpoint is considered appropriate for read-across purposes to C12 -14 AAPHS.

Description of key information

The 48 h EC50 of 9.3 mg test item/L (4.0 mg C12-18 AAPHS /L) was derived by graphical means. The corresponding NOEC was estimated to be 2.2 mg test item/L. This endpoint is considered appropriate for read-across purposes to C12 -14 AAPHS.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

4 mg/L

Additional information

A non-GLP Daphnia study conducted with Betadet SHR is also reported and provided a 48 hr EC50 of 3.5 mg/L, this study is used as supporting data.