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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

June to July 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

One main deviation noted, no chemical analysis was performed. The report is brief and doesn’t include background details of culturing etc.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

yes

Remarks:

One main deviation noted, no chemical analysis was performed. The report is brief and doesn’t include background details of culturing etc.

GLP compliance:

yes

Specific details on test material used for the study:

Betadet SH-R
Batch number 8070

Analytical monitoring:

no

Details on sampling:

Not applicable

Vehicle:

no

Details on test solutions:

The test material was dissolved in water.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Fish were obtained from a commercial supplier Meridiana Aquariam SA.
Fish were held is glass aquaria with a capacity of 84 L, pH was in the range of 8.0 - 8.6 and between 20 and 24°C
Fish were 3.0 - 3.8 cm at the end of the preliminary study and 3.0 - 3.4 cm at the end of the definitive test

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

None

Post exposure observation period:

Not applicacble

Hardness:

195.8 - 231.4 mg/L as CaC03 during the definitive study

Test temperature:

21-25°C

pH:

8.1 - 8.5 during the definitive study

Dissolved oxygen:

Maintained between 65 and 90% of the Air Saturation Value

Salinity:

Not applicable

Conductivity:

Not applicable

Nominal and measured concentrations:

Nominal exposure concentrations - 0 (control), 3.12, 6.25, 8.84 and 12.5 mg/L.

Details on test conditions:

Test vessels were glass aquaria containing 50 L of test medium.
10 fish were exposed in the control and 3.12, 6.25, and 12.5 mg/L treatments and 20 were exposed at the 8.84 mg/L treatment.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

6.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CI 5.12 - 7.96 mg/L

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

3.12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The 96 h LC50 for Betadet SH-R, based on nominal exposure concentrations was calculated to be 6.4 mg/L (95% CI of 5.12 - 7.96 mg/L) .

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

The LC50 and confience limits were calculated at 95% using the method of Litchfield and Wilcoxon 1949 (J Pharmacol. Exp. Ther.: 1949. 96. 99-113)

Sublethal observations / clinical signs:

Mortality observations

Nominal concentration (mg/L)	No. of fish exposed	Cumulative mortality					% mortality at 96 hours
		3 hours	24 hours	48 hours	72 hours	96 hours
Control	10	0	0	0	0	0	0
3.12	10	0	0	0	0	0	0
6.25	10	0	3	4	4	4	40
8.84	20	0	17	18	18	18	90
12.5	10	3	10	10	10	10	100

Validity criteria fulfilled:

yes

Conclusions:

The 96 h LC50 for Betadet SH-R, based on nominal exposure concentrations was calculated to be 6.4 mg/L (95% CI of 5.12 - 7.96 mg/L) .

Executive summary:

The acute toxicity of Betadet SH-R to Zebra fish (Brachydanio rerio) was determined in a static study carried out according to OECD test guideline 201 (1992). Fish were exposed to nominal test concentrations of 0 (control), 3.12, 6.25, 8.84 and 12.5mg/L for 96 hours. No analytical verification was performed therefore the results of the study are based in the nominal exposure concentrations. 

The 96 h LC50 for Betadet SH-R, based on nominal exposure concentrations was calculated to be 6.4 mg/L (95% CI of 5.12 - 7.96 mg/L).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 13, 1996 (final report)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study performed according to an international guideline but not 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. HHowever, 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:

OECD Guideline 203 (Fish, Acute Toxicity Test)

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:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method : the test solutions were prepared without using of any organic solvent
- Stock solution : 100 mg/L carbon-filtered well water
- test concentrations : prepared by addition of the appropriate amont of stock solution
- Controls : no data
- Evidence of undissolved material (e.g; precipate, surface film, etc) : No

Test organisms (species):

Pimephales promelas

Details on test organisms:

- Common name : Fathead minnow
- Strain : Pimephales promelas
- Source : Aquatic Biosystems, Inc., Fort Cllins, CO.
- Length at study initiation : 1.82 +/- 0.10 cm
- Weight at study initiation : 0.034 +/- 0.004 g
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD) : no data
- Weight at study initiation (mean and range, SD): no data
- Loading density (fish/litre) : 10 fish/beaker; 0.34 g/L
- Method of breeding: no data
- Feeding during test : no

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): no data
- Type and amount of food:TetraMin flake food
- Feeding frequency: daily until 72 hours before test initiation
- Feeding during the test : no
- Health during acclimation (any mortality observed): < 10% of the population in 7 days prior to test initiation

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

270 mg/L as CaCO3 (dilution water)
280 mg/L as CaCO3 (concentration of 5.0 mg/L)

Test temperature:

18.7 - 19.0°C (definitive test)

pH:

From 7.8 to 8.2 (test solutions) (definitive test)
7.5 (dilution water)

Dissolved oxygen:

From 71% to 87% of the air saturation value (definitive test)

Nominal and measured concentrations:

Nominal concentrations : 1.0, 2.5, 5.0, 7.5, 10.0 mg/L for the definitive test
Note: a range-finding test was performed previously to determine the concentration for use in the definitive test.

Details on test conditions:

TEST SYSTEM
Test vessel:
- Type (delete if not applicable): no data (open/closed)
- Material, size, headspace, fill volume: 1200 mL polypropylene beakers
- Test volume : 1000 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): -
- Renewal rate of test solution (frequency/flow rate): -
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): -
- Biomass loading rate: 0.34 g/L

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Carbon-filtered well water. 3M Well No.2, St. Paul, MN
- Treatment process : Water aerated 24-hours prior to test initiation. Well water (100%) was used for culturing the fish.
- Total organic carbon: 3.4 mg/L
- Total dissolved solids : 280 mg/L
- Total solids : 470 mg/L
- Total suspended solids : < 2 mg/L
- Metals: no data
- Pesticides: no data
- Total residual chlorine: < 0.02 mg/L
- Alkalinity: 250 mg/L
- Ca/mg ratio: no data
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hrs light; 8-hrs dark
- Lighting : Cool-white fluorecent light

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

4.87 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits = 3.92 - 6.06 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.12 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

Percent mortality values obtained after 24, 48, 72 and 96 hours of exposure to the test item are summarized in table 1.
In duplicated measurements, the median lethal concentration (96-hour LC50) for the test item was reported as 4.87 mg/L (equivalent to 2.12 mg active ingredient/L). The 95% confidence interval were 3.92 to 6.06 mg/L. The NOEC is < 0.1 mg/L. The LOEC is 1.0 mg/L.

Reported statistics and error estimates:

The reported values were based on nominal concentrations in the test media at the beginning of the test.
A total of 20 fish were exposed to each concentration. The concentrations tested and the corresponding response data derived from the duplicated toxicity test used to calculate, if possible, the median lethal concentration, LC50 and the 95% confidence interval by standard logistic regression methods (i.e., Probit Analysis, Trimmed Spearman-Karber).
The LC50 is defined as the concentration estimated to kill 50 percent of the fish after 96 hours exposure. The NOEC (No observed Effect Concentration) and LOEC (Lowest Observed Effect Concentration) are also determinated from the data.

Sublethal observations / clinical signs:

Table 1 -Percent mortality during the exposure period

PERCENT MORTALITY (%)
Test concentrations mg/L *	24-hrs	48-hrs	72-hrs	96-hrs
Blank control 1	0	0	0	0
Blank control (duplicate)	0	0	0	0
1 mg/L	0	10	20	20
1 mg/L (duplicate)	0	10	10	20
2.5 mg/L	0	10	10	20
2.5 mg/L (duplicate)	0	10	20	20
5 mg/L	0	30	30	40
5 mg/L (duplicate)	0	30	40	40
7.5 mg/L	100	100	100	100
7.5 mg/L (duplicate)	100	100	100	100
10.0 mg/L	100	100	100	100
10.0 mg/L (duplicate)	100	100	100	100

- 10 fish per replicate. A total of 20 fish were exposed per concentration

Validity criteria fulfilled:

yes

Remarks:

See remarks "Rationale for reliability incl. deficienties"

Conclusions:

The toxicity test meets quality criteria provides in test Guidelines :
- not more than 10% of the control fish were dead
- the Dissolved Oxygen Cocentrations were greater than 60% of the air saturation value at the temperature tested at the end of the test
- test temperature did not vary more than 1°C in any 24-hour period

Executive summary:

The acute toxicity of the test item to Fathead Minnow (Pimephales promelas) was determined in a 96-hour static test according the OECD Guideline for Testing of Chemicals No. 203 (1992) but not according to the principles of Good Laboratory Practices. Fathead Minnow were exposed to control and test chemical at the nominal concentrations of 1.0, 2.5, 5.0, 7.5, and 10.0 mg/L. The test fish were observed after 24, 48, 72 and 96 hours test duration for mortality and visible abnormalities. At the test concentrations of 1.0 and 2.5 mg/L, 20% of mortality was observed at the end of the test (96 -hours exposure). At the test concentrations of 7.5 and 10 mg/L (20 fish exposed/concentration), the death of all the fish was recorded during the first 24h of test duration. Clinical signs were exposed during the study period as : erratic swimming and some hemorrhaging.

The 96-hour LC50 to Fathead Minnow was calculated to be 4.87 mg test item/L (2.12 mg active ingredient/L).

Reference 3

Endpoint:

short-term toxicity to fish

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:

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:

96 h

Dose descriptor:

LC50

Effect conc.:

4.87 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits = 3.92 - 6.06 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.12 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

Percent mortality values obtained after 24, 48, 72 and 96 hours of exposure to the test item are summarized in table 1.
In duplicated measurements, the median lethal concentration (96-hour LC50) for the test item was reported as 4.87 mg/L (equivalent to 2.12 mg active ingredient/L). The 95% confidence interval were 3.92 to 6.06 mg/L. The NOEC is < 0.1 mg/L. The LOEC is 1.0 mg/L.

Reported statistics and error estimates:

The reported values were based on nominal concentrations in the test media at the beginning of the test.
A total of 20 fish were exposed to each concentration. The concentrations tested and the corresponding response data derived from the duplicated toxicity test used to calculate, if possible, the median lethal concentration, LC50 and the 95% confidence interval by standard logistic regression methods (i.e., Probit Analysis, Trimmed Spearman-Karber).
The LC50 is defined as the concentration estimated to kill 50 percent of the fish after 96 hours exposure. The NOEC (No observed Effect Concentration) and LOEC (Lowest Observed Effect Concentration) are also determinated from the data.

Sublethal observations / clinical signs:

Table 1 -Percent mortality during the exposure period

PERCENT MORTALITY (%)
Test concentrations mg/L *	24-hrs	48-hrs	72-hrs	96-hrs
Blank control 1	0	0	0	0
Blank control (duplicate)	0	0	0	0
1 mg/L	0	10	20	20
1 mg/L (duplicate)	0	10	10	20
2.5 mg/L	0	10	10	20
2.5 mg/L (duplicate)	0	10	20	20
5 mg/L	0	30	30	40
5 mg/L (duplicate)	0	30	40	40
7.5 mg/L	100	100	100	100
7.5 mg/L (duplicate)	100	100	100	100
10.0 mg/L	100	100	100	100
10.0 mg/L (duplicate)	100	100	100	100

- 10 fish per replicate. A total of 20 fish were exposed per concentration

Validity criteria fulfilled:

yes

Conclusions:

The toxicity test meets quality criteria provides in test Guidelines :
- not more than 10% of the control fish were dead
- the Dissolved Oxygen Cocentrations were greater than 60% of the air saturation value at the temperature tested at the end of the test
- test temperature did not vary more than 1°C in any 24-hour period

Executive summary:

The acute toxicity of the target substance, C12 -14 cocamidopropyl hydroxysultaine (C12 -14 AAPHS), to fathead minnow (Pimephales promelas) 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.

 

The acute toxicity of C12-18 AAPHS to Fathead Minnow (P. promelas) was determined in a 96-hour static test according the OECD Guideline for Testing of Chemicals No. 203 (1992) but not according to the principles of Good Laboratory Practices. Fathead Minnow were exposed to control and test chemical at the nominal concentrations of 1.0, 2.5, 5.0, 7.5, and 10.0 mg/L. The test fish were observed after 24, 48, 72 and 96 hours test duration for mortality and visible abnormalities. At the test concentrations of 1.0 and 2.5 mg/L, 20% of mortality was observed at the end of the test (96 -hours exposure). At the test concentrations of 7.5 and 10 mg/L (20 fish exposed/concentration), the death of all the fish was recorded during the first 24h of test duration. Clinical signs were exposed during the study period as erratic swimming and some haemorrhaging.

 

The 96-hour LC50 to Fathead Minnow was calculated to be 4.87 mg C12-18 AAPHS /L (equivalent to 2.12 mg active ingredient/L), and is considered appropriate for read-across purposes to C12 -14 AAPHS.

Description of key information

The 96-hour LC50 to Fathead Minnow was calculated to be 4.87 mg C12-18 AAPHS /L (equivalent to 2.12 mg active ingredient/L) and is considered appropriate for read-across purposes to C12 -14 AAPHS.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2.12 mg/L

Additional information

A fish study was conducted with Zebra fish and resulted in a 96 h LC50 for Betadet SH-R, based on nominal exposure concentrations of calculated to be 6.4 mg/L (95% CI of 5.12 - 7.96 mg/L). This study is considered to be a supporting study.