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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no analysis of test concentrations during the study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
no
Analytical monitoring:
no
Details on sampling:
not applicable
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions in both the preliminary and the definitive test were prepared from stock solutions of the test substance in deionised water. The test substance dissolved well and a clear and homogenous solution was obtained. The test concentrations were prepared by the addition of the respective amounts of stock solution to the Dutch Standard Water.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: no data
- Age at study initiation: no data
- Length at study initiation: approx. 2 cm
- Weight at study initiation: medium wetweight = 0.3 g/fish
- Feeding during test: no

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
not applicable
Test temperature:
21.3-21.6 deg C
pH:
7.5-8.2
Dissolved oxygen:
>7.3 mg/L
Salinity:
not measured
Nominal and measured concentrations:
Nominal concentrations:
Preliminary test: 0, 0.1, 1, 10, 32, 100 or 1000 mg/L (equivalent to 0, 0.0237, 0.237, 2.37, 7.58, 23.7 or 237 mg AO/L)
Definitive test: 0, 100, 180, 324, 583 or 1050 mg/L (equivalent to 0, 23.7, 42.66, 76.79, 138.17 or 248.85 mg AO/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: Aquarium
- Type: Covered with glass plate
- Material, size, headspace, fill volume: glass, 2 L capacity filled to 1 L (preliminary test) 5 L capacity filled to 3 L (definitive test)
- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): Renewed after 2 days (semi-static test)
- No. of organisms per vessel: 3 fish (preliminary test) 7 fish (definitive test)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dutch Standard Water
- Total organic carbon: <2.0 mg/L
- Metals: < 10 ug Cu/L
- Conductivity: < 5 uS/cm

OTHER TEST CONDITIONS
- Adjustment of pH: not applicable
- Photoperiod: 12 hours ambient light per day provided by fluorescent tubes


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: 0, 0.1, 1, 10, 32, 100 or 1000 mg/L (equivalent to 0, 0.0237, 0.237, 2.37, 7.58, 23.7 or 237 mg AO/L)
- Results used to determine the conditions for the definitive study: no mortality and no sublethal effects were observed at concentrations up to and including 100 mg/L (23.7 mg AO/L)
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
134 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
31.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: at 180 mg/L the fish showed reduced activity before their death. At 100 mg/L no sublethal effects were observed.
- Mortality of control: There were no deaths among control animals in either the preliminary or definitive study
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
The LC50 was calculated with a programme (Akzo programme SKBT, version 1.0) using both the trimmed Spearman-Karber method (5.3) and the binomial test method (5.4).
Sublethal observations / clinical signs:

Table 1: Mortality in the definitive test

Mg test substance/L

No. of surviving animals

 

Hours

 

0

2

18

24

42

67

96

0

7

7

7

7

7

7

7

100

7

7

7

7

7

7

7

180

7

7

7*

4*

1*

0

0

324

7

5

0

0

0

0

0

583

7

0

0

0

0

0

0

1050

7

0

0

0

0

0

0

 

* Reduced activity

Validity criteria fulfilled:
yes
Executive summary:

The acute toxicity of C12 AO to Danio rerio was determined in a 96-hour semi-static test performed according to OECD TG 203. The fish (7 per group) were exposed at nominal concentrations of 0, 23.7, 42.66, 76.79, 138.17 or 248.85 mg AO/L. The 96-h LC50 was reported as 31.8 mg AO/L.

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:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Both the target and source substances contain identical functional groups and differ only by the C-chain length. The ecotoxicological properties of these substances will be similar or predictable.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: Dodecyl(dimethyl)amine oxide (EC 216-700-6; CAS 1643-20-5)
Target: N,N-dimethyldecylamine N-oxide (EC 220-020-5; CAS 2605-79-0)

3. ANALOGUE APPROACH JUSTIFICATION
The target and source substances contain identical functional groups. The only difference between the two substances is the alkyl chain length (C10 in the target and C12 in the source). Most of the available studies on fish toxicity have been performed using Danio rerio. Unfortunately, some of the studies only report the toxicity in terms of a range rather than a more precise value. However, the results on this species are consistent with results on Oryzias latipes, Lepomis macrochirus and Pimephales promelas. Onchoryncchus mykiss shows the lowest sensitivity to C12-C14 and is assumed to be more resistant to AO than other species of fish. Based on the available studies, toxicity to fish increases moving from the C12 AO monoconstituent to C14 AO monoconstituent or the C12-14 AO UVCB. It is anticipated that the toxicity of C10 AO to fish will be of the same order of magnitude as C12 AO or even lower. In this case it is acceptable to read across from the toxicity value of C12 AO, i.e. LC50 = 31.8 mg AO/L as this is likely to represent a worst case assessment for C10 AO.

4. DATA MATRIX
Target: No data
Source (EC 216-700-6): 96-h EC50 = 31.8 mg AO/L (Danio rerio)
Supporting data:
C14 AO (EC 222-059-3): 96-h LC50 = 2.4 mg AO/L (Danio rerio); 96-h LC50 = 2.5-25 mg AO/L (Danio rerio)
C12-14 AO: 96-h LC50 = 2.67-3.46 mg AO/L (Pimephales promelas); 96-h LC50 = 3.13 mg AO/L (Lepomis macrochirus); 96-h LC50 = 12.6 mg AO/L (Oncorhynchus mykiss); 96-h LC50 = 3-30 mg AO/L (Danio rerio)
Reason / purpose for cross-reference:
read-across source
GLP compliance:
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
134 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
31.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987-06-22 to 1987-07-31
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
No analytical monitoring
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No analysis of test substance
GLP compliance:
no
Analytical monitoring:
no
Details on sampling:
No data
Vehicle:
no
Details on test solutions:
Loading of the test medium with the test sample was done 2 hours before the start of the test.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Forellenhof Fredesloh, Dr O Muller, 3413 Moringen 1
- Length at study initiation (length definition, mean, range and SD): 5 ± 1 cm

ACCLIMATION
- Acclimation period: 17 days
- Food: Trout food Pelletgr S 1 (Rheinkrone Kraft-futter)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No data
Hardness:
No data
Test temperature:
14.0 ± 0.5 degrees Centigrade at 0 hours
14.4 ± 0.9 degrees Centigrade at 24 hours
14.6 ± 0.3 degrees Centigrade at 48 hours
14.7 ± 0.3 degrees Centigrade at 72 hours
14.7 ± 0.4 degrees Centigrade at 96 hours
pH:
pH 8 throughout the period of the test
Dissolved oxygen:
Oxygen concentration was reported without units:
10.4 ± 0.3 at 0 hours
10.1 ± 0.4 at 24 hours
10.1 at 48 hours
10.1 ± 0.3 at 72 hours
10.1 ± 0.3 at 96 hours
Salinity:
No data
Nominal and measured concentrations:
Nominal concentrations of test substance: 0, 2.0, 3.0, 4.5, 6.7, 10.0, 15.0, 22.5, 33.5 and 50.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass tank
- Type (delete if not applicable): Closed via specially fitted glass plates
- Material, size, headspace, fill volume: Length 300 mm, width 200 mm, height 200 mm
- Aeration: Air was bubbled into the test medium at a rate of 1 to 3 bubbles per second through Pasteur pippettes directly connected with the aerator by flexible PVC tubes
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water prepared by dechlorinating the city water supply via active charcoal filters served as the test medium

OTHER TEST CONDITIONS
- Feeding: Withdrawn 24 hours before the test started
- Photoperiod: 12 hours
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
42 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
12.6 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
A range finding test indicated a mortality of at least 50 mg/L. Regular inspections during the acute toxicity test gave the results shown in the table below.
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
The cumulative percentage mortality for the exposure period of 96 hours was plotted against the log of the concentration of the test substance. A line was fitted to the points and the concentration corresponding to 50 % mortality was read from that line.
Sublethal observations / clinical signs:

Cummulative mortality and (percentage mortality) at intervals during the test

Concentration [mg/L]

Time after test start [h]

0

1

24

48

72

96

50.0

 

0

0

9

10

10

10

(0)

(0)

(90)

(100)

(100)

(100)

33.5

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

22.5

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

15.0

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

10.0

0

0

0

0

0

6

(0)

(0)

(0)

(0)

(0)

(60)

6.7

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

4.5

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

3.0

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

2.0

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

Negative Control

0

0

0

0

0

0

(0)

(0)

(0)

(0)

(0)

(0)

Validity criteria fulfilled:
yes
Remarks:
Control mortality < 10 %; dissolved oxygen concentration > 60 % of air saturation value; test material concentration not measured, but based on biodegradation studies expected to remain constant over the duration of the test
Conclusions:
The LC50 (96 h) was 42 mg/L test substance, equivalent to 12.6 mg AO/L.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non GLP study performed in a similar manner to the OECD Guideline but with no analytical validification of the test concentrations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Dilution in synthetic water
- Controls: Yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Dutch Standard water (pH ca. 8.2, hardness of 11.7°dH) + 1L of deionised water.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None
- Stock solution: 1 g test substance/L deionised water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: Not specified
- Age at study initiation (mean and range, SD): Not specified
- Length at study initiation (length definition, mean, range and SD): approx. 2 cm
- Weight at study initiation (mean and range, SD): approx 0.3 g (wet weight)
- Feeding during test: No

ACCLIMATION
- Acclimation period: Not specified
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
Dutch Standard Water: 11.7°dH
Test temperature:
22.1 - 22.3°C
pH:
7.4 - 8.2
Dissolved oxygen:
≥ 8.4 mg/L (92% of air saturation value)
Nominal and measured concentrations:
Preliinary Test: 0.1, 1, 10, 32 and 100 mg/L (technical product)
Definitive Test: 1, 2, 4, 8, 16 mg/L (technical product)
Details on test conditions:
TEST SYSTEM
- Test vessel: Preliminary test: 2L aquaria, Definitive test: 5L aquaria
- Type (delete if not applicable): closed (glass plate)
- Fill volume: 3L test medium
- Aeration: Yes
- Renewal rate of test solution (frequency/flow rate): test fluids renewed after 2 days


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water
- Total organic carbon: not more than 2.0 mg/L
- Metals: not more than 10 µg copper/L
- Conductivity: less than 5 µS/cm

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 12 hours
- Light intensity: ambient (fluorescent tubes)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 0.1, 1, 10, 32 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
10.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 8.5 - 12.3 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.4 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Mortality in preliminary test

mg of test substance*/L

Number of surviving animals

Hours

0

2

3

19

24

27

43

48

67

72

75

91

96

Control

3

3

3

3

3

3

3

3

3

3

3

3

3

0.1

3

3

3

3

3

3

3

3

3

3

3

3

3

1

3

3

3

3

3

3

3

3

3

3

3

3

3

10

3

3

3

3”

3’

2”

2”

2”

2”

2”

2”

2”

2”

32+

3

1”

0

 

 

 

 

 

 

 

 

 

 

* = technical product

“ = reduced activity

‘ = one fish almost dead, reduced activity

+ = slight foaming

Mortality in definitive test

mg of test substance*/L

Number of surviving animals

Hours

0

3

19

24

26

42

48

50

67

70

73

90

96

Control

7

7

7

7

7

7

7

7

7

7

7

7

7

1

7

7

7

7

7

7

7

7

7

7

7

7

7

2

7

7

7

7

7

7

7

7

7

7

7

7

7

4

7

7

7

7

7

7

7

7

7

7

7

7

7

8

7

7

7

7

7

7

7

7

7

6

6

6

6

16+

7

7’

0

 

 

 

 

 

 

 

 

 

 

* = technical product

‘ = reduced activity

+ = slight foaming

Validity criteria fulfilled:
yes
Conclusions:
The LC50 (96h) was calculated to be 10.3 mg/L equivalent to 2.4 mg AO/L.
Executive summary:

In a 96 h acute toxicity study Zebra fish (Brachydanio rerio) were exposed to C14 AO under semi-static conditions. The LC 50 (96h) value based on nominal concentration of the test material was 10.3 mg/L. The LC50 (96h) based on 100% active ingredient was 2.4 mg/L. This toxicity study is classified as acceptable and is similar to the OECD 203 Guideline.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
not specified
Remarks:
but GLP conform
Analytical monitoring:
not specified
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The substance was stirred with a glass stirrer and added to test water without any pretreatment.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Length at study initiation: 2.8 cm (2.5 - 3.1 cm)

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
22 +/- 1 °C
pH:
7.6 - 8..1
Dissolved oxygen:
7.0 - 9.0 mg/L
Nominal and measured concentrations:
nominal concentrations: 0, 10, 100 mg/L
Details on test conditions:
TEST SYSTEM
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: O2, pH and temperature were measured daily

EFFECT PARAMETERS MEASURED : mortality and behavior after 2, 4, 24, 48, 72 and 96 hours

Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 - < 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Abnormal behavior in the concentration of 10 mg/L.

Conclusions:
In this study the test substance was found to be toxic to Danio rerio after 96 hrs at a nominal test iten concentration of 100 mg/L. The LC50 (96 hrs) is between 10 and 100 mg/L (equivalent to 3-30 mg AO/L). A NOEC could not be defined because all tested concentrations shows effects.
Executive summary:

The acute toxicity of the test substance to Danio rerio was dtermined in a 96 -hour static test according to the OECD Guideline 203.

The concentrations of the test item of 10 and 100 mg/L were tested in parallel with a control. There was no mortality at the control group. The tested concentration of 10 mg/L shows effects but no mortality. The highest tested concentration without lethality was 10 mg/L. The LC50 was between 10 and 100 mg/L (no calculation), equivalent to 3 -30 mg AO/L. The lowest tested concentration with 100 % effect (mortality) was 100 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Non GLP study. No analytical validification of the test concentrations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Length at study initiation: 2.80+/-0.16 cm

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
22 ± 1°C
pH:
7.8-8.1
Dissolved oxygen:
7.6-9.0 mg/L
Salinity:
no data
Nominal and measured concentrations:
0, 10, 100 mg/L nominal
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 - < 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 2.5 - < 25 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
All fish died within 2-4 h observation period at 100 mg/L test concentration
Executive summary:

In a study performed to OECD 203, the test material was dosed at 0, 10 or 100 mg/L (equivalent to 0, 2.5 or 25 mg AO/L) to Zebra fish for 96 h. No mortalities were observed at the 2.5 mg AO/L test concentration but all fish died within 2 - 4 hours of dosing with 25 mg AO/L. The LC50 is between 2.5 and 25 mg AO/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975-01-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no measurement of test concentration.
Qualifier:
according to guideline
Guideline:
other: APHA Standard Method (1971). Reliability, deviations, and validity evaluated against APHA Standard Method 8910 (1997).
Deviations:
yes
Remarks:
(No measurements of test concentrations. Acclimation period was 24 h instead of at east 48 h. DO not measured.
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Analytical monitoring:
no
Details on sampling:
- Concentrations: Not available
- Sampling method: Not available
- Sample storage conditions before analysis: Not available
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solutions of the toxicant were prepared by weighing out the compound in on an analytical balance and then bringing the stock solution to final volume with distilled water. Concentrations were based upon active ingradient.
- Eluate: Not applicable
- Differential loading: Not applicable
- Controls: Prepared using same dilution water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow
- Strain: Not available
- Source: National water quality laboratory, Duluth, Minnesota.
- Age at study initiation (mean and range, SD): 40-60 days old
- Length at study initiation (length definition, mean, range and SD): Maximun mean length: 33.6 mm
- Weight at study initiation (mean and range, SD): Mean weight: 0.31 g
- Method of breeding: Not available
- Feeding during test: Not available
- Food type: Not available
- Amount: Not available
- Frequency: Not available


ACCLIMATION
- Acclimation period: 24 hours
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Not fed
- Feeding frequency: Not applicable
- Health during acclimation (any mortality observed): Not available


QUARANTINE (wild caught)
- Duration: Not applicable
- Health/mortality: Not applicable
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96
Remarks on exposure duration:
h
Post exposure observation period:
Not applicable
Hardness:
For Soft water: 48 mg/L as CaCO3
For Well water: 220 mg/L as CaCO3
For well water: 212 mg/L as CaCO3
For well water: 214 mg/L as CaCO3
Test temperature:
For all water types temperature was maintained at 22 degree C
pH:
For Soft water: 7.5
For Well water: 6.0
For well water: 7.8
For well water: 9.0
Dissolved oxygen:
Not available
Salinity:
Not applicable
Nominal and measured concentrations:
Test concentrations were not specified.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed: Not available
- Material, size, headspace, fill volume: Jars
- Aeration: Not available
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: Not available
- No. of vessels per concentration (replicates): Not available
- No. of vessels per control (replicates): Not available
- No. of vessels per vehicle control (replicates): Not applicbale
- Biomass loading rate: Not available


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: 4 different dilution waters were used. One was a reconstituted water; the other 3 were partially softened well water, buffered to different pH's. See Table below for details of these 4 waters.
- Total organic carbon: Not available
- Particulate matter: Not available
- Metals: Not available
- Pesticides: Not available
- Chlorine: Not available
- Alkalinity: See Table below
- Ca/mg ratio: Not available
- Conductivity: Not available
- Culture medium different from test medium: Not available
- Intervals of water quality measurement:


OTHER TEST CONDITIONS
- Adjustment of pH: Not applicable
- Photoperiod: Not available
- Light intensity: Not available


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality was observed at 24, 48 and 96 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not available
- Justification for using less concentrations than requested by guideline: Not available
- Range finding study: Yes
- Test concentrations: Not available
- Results used to determine the conditions for the definitive study: Not available
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.46 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 3.29-3.63 mg/L; Reconstituted water (pH 7.5)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.18 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 2.83-3.58 mg/L; Well water (pH 6.0)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.67 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 2.50-2.87 mg/L; Well water (pH 7.9)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.41 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 3.22-3.60 mg/L; Well water (pH 9.0)
Details on results:
- Behavioural abnormalities: None
- Observations on body length and weight: None
- Other biological observations: None
- Mortality of control: Not available
- Other adverse effects control: Not available
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: None
Results with reference substance (positive control):
Not available
Reported statistics and error estimates:
LC50 and its 95% CL were determined by moving average (Thompson, 1947)
Validity criteria fulfilled:
yes
Remarks:
Criteria of Standard Method 8910: Mortality of controls <10%
Conclusions:
The nominal 96 h acute toxicity of Alkyl Dimethyl Amine Oxide to fathead minnow ranged from 2.67 to 3.46 mg a.i./L in 4 different dilution waters.
Executive summary:

In a 96 h acute toxicity study, Fathead minnow (Pimephales promelas) were exposed to Alkyl Dimethyl Amine Oxide under static conditions. The 96 h LC50 value based on nominal concentration of active ingradient ranged from 2.67 to 3.46 mg a.i./L as follows:

Reconstituted Water, pH 7.5       3.46 mg/L

Well water, pH 6.0                     3.18 mg/L

Well water, pH 7.9                     2.67 mg/L

Well water, pH 9.0                     3.41 mg/L

This toxicity study is classified as acceptable and satisfies the guideline requirements for the APHA Standard Method 8921 (1997) Fish acute toxicity study.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976-06-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no measurement of test concentration.
Qualifier:
according to guideline
Guideline:
other: APHA Standard Method (1970). Reliability, deviations and validity criteria evaluated against APHA Standard Method 8910 (1997).
Deviations:
yes
Remarks:
(10 fish per test concentration, not 20. Details on DO measurements not provided. No measurement of test concentration.)
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Analytical monitoring:
no
Details on sampling:
Note: samples were collected, preserved, and sent to sponsor for analysis. However, details of the analytical measurement, and results, are not provided in this study report.
- Concentrations: Samples of 100 ml of test solutions were removed from selected concentrations (0.65, 2.8, 8.7mg/L) at various time intervals 0, 4, 8, 24, 48, 96h. in each test
- Sampling method: 100ml of samples were collected at each sampling period and added to 1ml of 37% formaldehyde
- Sample storage conditions before analysis: All water samples were shipped to the Procter & Gamble Company for chemical analyses
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:Reconstituted water used in the test system was prepared by adding 2mg potassium chloride, 30mg calcium sulfate, 30mg magnesium sulfate, and 48mg sodium bicarbonate per liter. The pH of the diluent was 7.1 and methyl orange alkalinity was 35ppm as CaCO3 and total hardness was 35mg/L
- Eluate: Not applicable
- Differential loading: Not applicable
- Controls: Control vessel contained 100 % reconstituted dilution water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None
Test organisms (species):
Lepomis macrochirus
Details on test organisms:
TEST ORGANISM
- Common name: Bluegill
- Strain: Not available
- Source: Commercial fish hatchery in Nebraska
- Age at study initiation (mean and range, SD): Not available
- Length at study initiation (length definition, mean, range and SD): mean length of 43mm
- Weight at study initiation (mean and range, SD): mean weight of 1.2g
- Method of breeding: Not available
- Feeding during test: Not available
- Food type: Not available
- Amount: Not available
- Frequency: Not available


ACCLIMATION
- Acclimation period: at least 24h in the water quality and test conditions
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Not available
- Feeding frequency: Not available
- Health during acclimation (any mortality observed): Not available


QUARANTINE (wild caught)
- Duration: Not applicable
- Health/mortality: Not applicable
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not applicable
Hardness:
35mg/L as CaCO3
Test temperature:
Static bioassays were conducted at 18 (+/-0.5) degree C in water bath
pH:
pH measured at 0, 48 and 96h pH ranged as follows:
Control: 7.1
For 0.65 mg/L :7.1
For 2.8 mg/L: 7-7.1
For 8.7 mg/L: 6.8-7.3
Dissolved oxygen:
DO levels ranged from initially 9.8 to 5.4 mg/L at the end of the test.
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal laboratory exposure concentrations based on active ingredient were 0(control), 0.65, 1.2, 2.8, 4.9, 6.5, 8.7 mg/L.
No measurement of test concentrations
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed: Not available
- Material, size, headspace, fill volume: 5 gallon glass vessels
- Aeration: Not aerated
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: Not available
- No. of vessels per concentration (replicates):Not available
- No. of vessels per control (replicates): Not available
- No. of vessels per vehicle control (replicates): Not available
- Biomass loading rate: Not applicable


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The reconstituted water used in the test was prepared by adding NaHCO3 (48 mg/L), CaSO4 (30 mg/L), MgSO4 (30 mg/L), and KCl (2mg/L) to deionized water.
- Total organic carbon: Not available
- Particulate matter: Not available
- Metals: Not available
- Pesticides: Not available
- Chlorine: Not available
- Alkalinity: 35ppm as CaCO3
- Ca/mg ratio: 30mg/L CaSO4 / 30mg/L MgSO4
- Conductivity: Not available
- Culture medium different from test medium: No
- Intervals of water quality measurement: Temperature and DO were measured initially and at the end of the test, pH was observed at 24 and 96 hours.


OTHER TEST CONDITIONS
- Adjustment of pH: Not applicable
- Photoperiod: Not available
- Light intensity: Not available


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality of Bluegill was measured at 24 and 96h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.3 -2.3
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study: No
- Test concentrations: Not applicable
- Results used to determine the conditions for the definitive study: Not applicable
Reference substance (positive control):
yes
Remarks:
p,p' DDT
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.13 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL 2.02-4.84mg/L. The study report included the endpoints as TL50 values. TL50 and LC 50 values are equivalent.
Details on results:
- Behavioural abnormalities: None
- Observations on body length and weight: None
- Other biological observations: Fish generally became dark and lethargic, lost equilibrium, and expired
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: None
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Mortality: Not available
- LC50: 0.007mg/L
- Other: 95%CL at 96h: 0.004 - 0.011mg/L
Reported statistics and error estimates:
LC50 values and it's 95% confidence limits for 96h were calculated by converting the test concentrations and corresponding mortalities to logs and probits, respectively. These values were utilized to calculated linear regression equation.
Validity criteria fulfilled:
yes
Remarks:
Criteria of Standard Method 8910: Mortality of controls <10%
Conclusions:
The 96 h LC50 of Alkyl dimethyl amine oxide to Bluegill was 3.13 mg a.i./L (based on nominal test concentration) with 95% CL of 2.02- 4.84mg/L.
Executive summary:

In a 96 hours acute toxicity study, Bluegill (Lepomis macrochirus) were exposed to Alkyl dimethyl amine oxide (NPS-72.004) at nominal concentrations of 0 (control), 0.65, 1.2, 2.8, 4.9, 6.5, 8.7 mg a.i./L under static conditions. No measurement of test concentration. The 96h LC50 value based on mortality was 3.13 mg a.i./L with 95%CL of 2.02 -4.84mg a.i. /L.

This toxicity study is classified as acceptable and satisfies the guideline requirement for the APHA Standard Method (1997) acute fish toxicity study.

Description of key information

No acute fish toxicity studies have been performed using C10 AO. However, data are available C12 AO, C14 AO and C12-14 AO. Based on the trend seen in the results from these studies it is anticipated that the toxicity of C10 AO to fish will be of the same order of magnitude as C12 AO or even lower. In this case it is acceptable to read across from the toxicity value of C12 AO, i.e. LC50 = 31.8 mg AO/L as this is likely to represent a worst case assessment for C10 AO.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
31.8 mg/L

Additional information

No acute fish toxicity studies have been performed using C10 AO. However, data are available C12 AO, C14 AO and C12-14 AO.

The acute toxicity of C12 AO to Zebra fish (Danio rerio) was determined in a 96-hour semi-static test performed according to OECD TG 203. The fish (7 per group) were exposed at nominal concentrations of 0, 23.7, 42.66, 76.79, 138.17 or 248.85 mg AO/L. The 96-h LC50 was reported as 31.8 mg AO/L [Mark UE & Arends ICM (1992)].

Two reliable studies are available for C14 AO. In the first study, performed according to OECD TG 203, Danio rerio were exposed to the substance under semi-static conditions for 96 hours at nominal concentrations of 0, 0.23, 0.46, 0.92, 1.84 or 3.68 mg AO/L [Mark UE (1992)]. The 96-h LC50 was 2.4 mg AO/L. In the second study, also performed according to OECD TG 203, Danio rerio were exposed to the substance at 0, 2.5 or 25 mg/L AO for 96 hours [Jung R (1987)]. The 96-h LC50 was between 2.5 and 25 mg AO/L.

There are four reliable studies available for the C12-14 AO. Iwan GR et al (1975) exposed Fathead minnow (Pimephales promelas) to C12-14 AO under static conditions for 96 hours. The LC50 (96 h) based on nominal concentrations of amine oxide ranged from 2.67 to 3.46 mg AO/L depending on the source and pH of the water used. In a supporting study Bluegill (Lepomis macrochirus) were exposed to C12-14 AO under static conditions for 96 hours. The LC50 value was reported as 3.13 mg AO/L [Macek & Sleight (1972)]. Exposure of rainbow trout (Oncorhynchus mykiss) to C12-14 AO under static conditions for 96 hours resulted in a LC50 of 12.6 mg AO/L [Dommrose AM (1987)], whilst exposure of Danio rerio to C12-14 AO under static conditions resulted in a 96 -h LC50 of 3 -30 mg AO/L [Hoechst AG (1987)].

Most of the available studies on fish toxicity have been performed using Danio rerio. Unfortunately, some of the studies only report the toxicity in terms of a range rather than a more precise value. However, the results on this species are consistent with results on Oryzias latipes, Lepomis macrochirus and Pimephales promelas. Oncorhynchus mykiss shows the lowest sensitivity to C12-C14 and is assumed to be more resistant to AO than other species of fish. Based on the available studies, toxicity to fish increases moving from the C12 AO monoconstituent to C14 AO monoconstituent or the C12-14 AO UVCB. It is anticipated that the toxicity of C10 AO to fish will be of the same order of magnitude as C12 AO or even lower. In this case it is acceptable to read across from the toxicity value of C12 AO, i.e. LC50 = 31.8 mg AO/L as this is likely to represent a worst case assessment for C10 AO.