Fatty acids, tall-oil, compds. with triethanolamine

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:

key study

Study period:

12th April 2001 - 18th June 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Read across Justification is attached in section 13.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

The pH of the holding water was <6.5 prior to test commencement which deviated from protocol. The pH also dropped below 6.5 in the control vessels at the end of the study. These deviations were not considered to affect the vailidity of the study.

Qualifier:

according to guideline

Guideline:

other: OECD Paris (2000), Guidence Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment , No. 23. ENV/JM/MONO

Deviations:

yes

Remarks:

The pH of the holding water was <6.5 prior to test commencement which lies outside protocol limits and is a deviation. The pH also dropped below 6.5 in the control vessels at the end of the study. These deviations were not considered to affect the study.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: Piine Chemical Association, Inc
- Appearence: Viscous brown liquid
- Batch No.of test material: 5-10-00-17
- Expiration date of the batch: 15 May 2006

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Preparation of Water Accommodated Fractions (WAF):

An individual WAF was prepared for each test level. Exposure levels were based on the initial weight of test item added to each vessel (initial loading rate). WAF were prepared in 20 litre capacity glass vessels, with 20 litres of Inveresk reconstituted freshwater. Vssels were placed on a magnetic stirrer and a stir bar added. The appropriate weight of the test item was added to the stirring medium and the vessels were sealed to avoid contamination and loss of volatile fractions. After the test item addition, the stirring speed was adjusted to give a stirring vortex 5 - 10% of the water column.

After a stirring period of ca. 48h, the medium was allowed to settle for ca. 1h and the aqueous phase removed via a glass siphon. The first ca. 100 ml of siphoned medium was discarded before ca. 15 litres of WAF was collected for use as test medium. Control medium, without the addition of test item, was stirred and extracted in an identical way to the treated media, using the same volume of extract.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnows
- Source: Osage Catfisheries (USA), received on 3 May 2001.
- Length at study initiation (length definition, mean, range and SD): 1 to 3 cm

ACCLIMATION
- Acclimation period: All fish were acclimatised to laboratory conditions for a minimum of 12 days prior to study commencement.
- Type and amount of food during acclimation: Fish were fed on a suitable standard fish diet during holding. The fish were not fed for a period of 24h before the commencement of the tests or throughout the duration of the tests.

FEEDING DURING TEST
- Frequency: Not fed throughout the duration of the tests.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Water hardness was determined at commencement of the definitive-limit test as 66 mg CaCO3 l-1.

Test temperature:

22.5 - 24.9°C

pH:

5.27 - 6.77.
* The pH of the holding water was <6.5 prior to test commencement, which is outside protocol limits and a protocol deviation. However, the pH was >6.0, the guideline minimum. Similarly the pH dropped below 6.5 in the control vessels at the end of the study.

These protocol deviations did not affect the outcome of the test as no mortality or other effects were observed. The pH of the highest loading rate was

Dissolved oxygen:

80.9 - 96.0%

Conductivity:

0.17 - 0.24 mS

Nominal and measured concentrations:

Based on results of the range finding test a definitive-limit test was conducted with WAF prepared at a maximum initial loading rate of 1000 mg.l-1, with an untreated control.

Details on test conditions:

TEST SYSTEM
- Test vessel: Tanks of ca. 15 litre capacity (moulded glass construction) and covered with perspex lids to minimise contamination and evaporation loss.
- Type (delete if not applicable): closed
- Aeration: Tanks were constantly aerated throughout the duration of the test.
- 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: Parameters were recorded at 0 and 24h during the range finding test and 0, 24, 48, 72 and 96h during the definitive-limit test.

OTHER TEST CONDITIONS
- Photoperiod: A light cycle of 16h light and 8 hours dark throughout the test.
- Light intensity: Artificial daylight fluorescent tubes provided illumination. Light intensity range in test rooms was 540 - 800 lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 96h LL50 and 96h NOELr. Fiish in the definitive-limit test were observed at 1, 3, 6, 24, 48, 72 and 96h.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: A range finding test was conducted under static conditions over a 24h period using medium prepared as WAF from initial loading rates of 1000, 100, 10, 1 and 0 mg.l-1.
- Results used to determine the conditions for the definitive study: Based on the results of the range finding test, the definitive test was conducted with a WAF prepared at an initial loading rate of 1000 mg.l-1. In the dose range finding test, no mortality or other effects were observed at any test level, including the pH adjusted and filtered test groups.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none seen.
- Observations on body length and weight: At the termination in the definitive-limit test, the length (tip of the snout to the caudal peduncle) and weight of each surviving fish was recorded, including any visible abnormalities. For the initial loading rate of 1000 mg.l-1 the mean length was 217.6 mm (S.D. 14.0 mm) and the mean weight was 86.9 mm (S.D. 15.0 mm). For the control the mean length was 209.5 mm (S.D. 16.9 mm) and the mean weight was 84.5 mm (S.D. 27.8 mm).
- Mortality of control: None.

Sublethal observations / clinical signs:

Cumulative Mortality Recorded at 0, 24, 48, 72 and 96h During the Definitive-Limit Test

Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)	0h Mortality	24h Mortality	48h Mortality	72h Mortality	96h Mortality
1000	0/10	0/10	0/10	0/10	0/10
0	0/10	0/10	0/10	0/10	0/10

No mortality was observed at 1, 3 and 6h.

Surviving Fish Lengths and Weights

Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)	Fish No.	Length (mm)	Weight (mg)
1000	1	226	95.2
1000	2	236	94.0
1000	3	211	99.9
1000	4	191	54.4
1000	5	217	104.6
1000	6	219	82.7
1000	7	226	94.8
1000	8	198	76.1
1000	9	226	92.1
1000	10	226	74.9
1000	Mean	217.6	86.9
1000	S.D.	14.0	15.0
0	1	239	150.7
0	2	182	47.3
0	3	220	90.7
0	4	194	79.7
0	5	202	68.7
0	6	220	80.0
0	7	196	62.7
0	8	215	92.8
0	9	204	74.4
0	10	223	98.3
0	Mean	209.5	84.5
0	S.D.	16.9	27.8

S.D = Standard Deviation

Water Quality Parameters Recorded at 0, 24, 48, 72 and 96h During the Definitive-Limit Test

	Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)
Parameter	1000	0
At 0h
pH	5.27	6.54
Temperature (°C)	24.9	23.3
Conductivity (mS)	0.21	0.22
Dissolved Oxygen (%)	82.0	91.0
At 24h
pH	5.83	6.53
Temperature (°C)	23.4	23.1
Conductivity (mS)	0.23	0.24
Dissolved Oxygen (%)	84.3	89.9
At 48h
pH	6.39	6.72
Temperature (°C)	22.9	22.6
Conductivity (mS)	0.20	0.20
Dissolved Oxygen (%)	83.4	85.6
At 72h
pH	6.77	6.57
Temperature (°C)	23.2	23.3
Conductivity (mS)	0.17	0.18
Dissolved Oxygen (%)	80.9	81.7
At 96h
pH	6.37	6.38
Temperature (°C)	23.2	22.5
Conductivity (mS)	0.19	0.18
Dissolved Oxygen (%)	92.3	96.0

Validity criteria fulfilled:

not specified

Remarks:

although not stated in the report, validity criteria appear to have been sufficiently met.

Conclusions:

No mortalities or other effects were observed in fathead minnows during the study. The 96h LL50 was >1000 mg.l-1 Fatty acids, Tall oil (CAS No. 61790-12-3), the highest initial loading rate. The No Observed Effect Loading Rate (NOELr) was 1000 mg.l-1, under the conditions of the test.

Executive summary:

The study was designed to determine the median lethal loading (LL50) of Fatty acids, Tall oil, CAS No. 61790 -12 -3, by exposing fathead minnows (Pimephales promelas) under static conditions to solutions prepared as Water Accomodated Fractions (WAF) at different loading rates; and was performed based on procedures in OECD (1992) Guideline 203, and following procedures in OECD (2000) Guidance Document No. 23 on Testing Difficult Substances, according to GLP. Following the results of a range finding test, a definitive-limit test was conducted at a maximum loading rate of 1000 mg.l-1, with an untreated control.

 

During the definitive-limit test, environmental conditions were within the following ranges, pH: 5.27 -6.77, dissolved oxygen: 80.9 -6.0%, temperature: 22.5 -24.9°C and conductivity 0.17 -0.24 mS. The light level in the test room was 640 lux.

 

No mortality or other effects were observed in the test fish during the study. The 96h LL50 was >1000 mg.l-1, the highest loading rate tested. The No Observed Effect Loading Rate (NOELr) was also 1000 mg.l-1, under the conditions of the test.

 

This guideline, GLP-compliant study has been evaluated as being reliable without restriction.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Read across Justification is attached in section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

The pH of the holding water was <6.5 prior to test commencement which deviated from protocol. The pH also dropped below 6.5 in the control vessels at the end of the study. These deviations were not considered to affect the vailidity of the study.

Qualifier:

according to guideline

Guideline:

other: OECD Paris (2000), Guidence Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment , No. 23. ENV/JM/MONO

Deviations:

yes

Remarks:

The pH of the holding water was <6.5 prior to test commencement which lies outside protocol limits and is a deviation. The pH also dropped below 6.5 in the control vessels at the end of the study. These deviations were not considered to affect the study.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source: Piine Chemical Association, Inc
- Appearence: Viscous brown liquid
- Batch No.of test material: 5-10-00-17
- Expiration date of the batch: 15 May 2006

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Preparation of Water Accommodated Fractions (WAF):

An individual WAF was prepared for each test level. Exposure levels were based on the initial weight of test item added to each vessel (initial loading rate). WAF were prepared in 20 litre capacity glass vessels, with 20 litres of Inveresk reconstituted freshwater. Vssels were placed on a magnetic stirrer and a stir bar added. The appropriate weight of the test item was added to the stirring medium and the vessels were sealed to avoid contamination and loss of volatile fractions. After the test item addition, the stirring speed was adjusted to give a stirring vortex 5 - 10% of the water column.

After a stirring period of ca. 48h, the medium was allowed to settle for ca. 1h and the aqueous phase removed via a glass siphon. The first ca. 100 ml of siphoned medium was discarded before ca. 15 litres of WAF was collected for use as test medium. Control medium, without the addition of test item, was stirred and extracted in an identical way to the treated media, using the same volume of extract.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnows
- Source: Osage Catfisheries (USA), received on 3 May 2001.
- Length at study initiation (length definition, mean, range and SD): 1 to 3 cm

ACCLIMATION
- Acclimation period: All fish were acclimatised to laboratory conditions for a minimum of 12 days prior to study commencement.
- Type and amount of food during acclimation: Fish were fed on a suitable standard fish diet during holding. The fish were not fed for a period of 24h before the commencement of the tests or throughout the duration of the tests.

FEEDING DURING TEST
- Frequency: Not fed throughout the duration of the tests.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

Water hardness was determined at commencement of the definitive-limit test as 66 mg CaCO3 l-1.

Test temperature:

22.5 - 24.9°C

pH:

5.27 - 6.77.
* The pH of the holding water was <6.5 prior to test commencement, which is outside protocol limits and a protocol deviation. However, the pH was >6.0, the guideline minimum. Similarly the pH dropped below 6.5 in the control vessels at the end of the study.

These protocol deviations did not affect the outcome of the test as no mortality or other effects were observed. The pH of the highest loading rate was

Dissolved oxygen:

80.9 - 96.0%

Conductivity:

0.17 - 0.24 mS

Nominal and measured concentrations:

Based on results of the range finding test a definitive-limit test was conducted with WAF prepared at a maximum initial loading rate of 1000 mg.l-1, with an untreated control.

Details on test conditions:

TEST SYSTEM
- Test vessel: Tanks of ca. 15 litre capacity (moulded glass construction) and covered with perspex lids to minimise contamination and evaporation loss.
- Type (delete if not applicable): closed
- Aeration: Tanks were constantly aerated throughout the duration of the test.
- 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: Parameters were recorded at 0 and 24h during the range finding test and 0, 24, 48, 72 and 96h during the definitive-limit test.

OTHER TEST CONDITIONS
- Photoperiod: A light cycle of 16h light and 8 hours dark throughout the test.
- Light intensity: Artificial daylight fluorescent tubes provided illumination. Light intensity range in test rooms was 540 - 800 lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 96h LL50 and 96h NOELr. Fiish in the definitive-limit test were observed at 1, 3, 6, 24, 48, 72 and 96h.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: A range finding test was conducted under static conditions over a 24h period using medium prepared as WAF from initial loading rates of 1000, 100, 10, 1 and 0 mg.l-1.
- Results used to determine the conditions for the definitive study: Based on the results of the range finding test, the definitive test was conducted with a WAF prepared at an initial loading rate of 1000 mg.l-1. In the dose range finding test, no mortality or other effects were observed at any test level, including the pH adjusted and filtered test groups.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none seen.
- Observations on body length and weight: At the termination in the definitive-limit test, the length (tip of the snout to the caudal peduncle) and weight of each surviving fish was recorded, including any visible abnormalities. For the initial loading rate of 1000 mg.l-1 the mean length was 217.6 mm (S.D. 14.0 mm) and the mean weight was 86.9 mm (S.D. 15.0 mm). For the control the mean length was 209.5 mm (S.D. 16.9 mm) and the mean weight was 84.5 mm (S.D. 27.8 mm).
- Mortality of control: None.

Sublethal observations / clinical signs:

Cumulative Mortality Recorded at 0, 24, 48, 72 and 96h During the Definitive-Limit Test

Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)	0h Mortality	24h Mortality	48h Mortality	72h Mortality	96h Mortality
1000	0/10	0/10	0/10	0/10	0/10
0	0/10	0/10	0/10	0/10	0/10

No mortality was observed at 1, 3 and 6h.

Surviving Fish Lengths and Weights

Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)	Fish No.	Length (mm)	Weight (mg)
1000	1	226	95.2
1000	2	236	94.0
1000	3	211	99.9
1000	4	191	54.4
1000	5	217	104.6
1000	6	219	82.7
1000	7	226	94.8
1000	8	198	76.1
1000	9	226	92.1
1000	10	226	74.9
1000	Mean	217.6	86.9
1000	S.D.	14.0	15.0
0	1	239	150.7
0	2	182	47.3
0	3	220	90.7
0	4	194	79.7
0	5	202	68.7
0	6	220	80.0
0	7	196	62.7
0	8	215	92.8
0	9	204	74.4
0	10	223	98.3
0	Mean	209.5	84.5
0	S.D.	16.9	27.8

S.D = Standard Deviation

Water Quality Parameters Recorded at 0, 24, 48, 72 and 96h During the Definitive-Limit Test

	Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)
Parameter	1000	0
At 0h
pH	5.27	6.54
Temperature (°C)	24.9	23.3
Conductivity (mS)	0.21	0.22
Dissolved Oxygen (%)	82.0	91.0
At 24h
pH	5.83	6.53
Temperature (°C)	23.4	23.1
Conductivity (mS)	0.23	0.24
Dissolved Oxygen (%)	84.3	89.9
At 48h
pH	6.39	6.72
Temperature (°C)	22.9	22.6
Conductivity (mS)	0.20	0.20
Dissolved Oxygen (%)	83.4	85.6
At 72h
pH	6.77	6.57
Temperature (°C)	23.2	23.3
Conductivity (mS)	0.17	0.18
Dissolved Oxygen (%)	80.9	81.7
At 96h
pH	6.37	6.38
Temperature (°C)	23.2	22.5
Conductivity (mS)	0.19	0.18
Dissolved Oxygen (%)	92.3	96.0

Validity criteria fulfilled:

not specified

Remarks:

although not stated in the report, validity criteria appear to have been sufficiently met.

Conclusions:

No mortalities or other effects were observed in fathead minnows during the study. The 96h LL50 was >1000 mg.l-1 Fatty acids, Tall oil (CAS No. 61790-12-3), the highest initial loading rate. The No Observed Effect Loading Rate (NOELr) was 1000 mg.l-1, under the conditions of the test.

Executive summary:

The study was designed to determine the median lethal loading (LL50) of Fatty acids, Tall oil, CAS No. 61790 -12 -3, by exposing fathead minnows (Pimephales promelas) under static conditions to solutions prepared as Water Accomodated Fractions (WAF) at different loading rates; and was performed based on procedures in OECD (1992) Guideline 203, and following procedures in OECD (2000) Guidance Document No. 23 on Testing Difficult Substances, according to GLP. Following the results of a range finding test, a definitive-limit test was conducted at a maximum loading rate of 1000 mg.l-1, with an untreated control.

 

During the definitive-limit test, environmental conditions were within the following ranges, pH: 5.27 -6.77, dissolved oxygen: 80.9 -6.0%, temperature: 22.5 -24.9°C and conductivity 0.17 -0.24 mS. The light level in the test room was 640 lux.

 

No mortality or other effects were observed in the test fish during the study. The 96h LL50 was >1000 mg.l-1, the highest loading rate tested. The No Observed Effect Loading Rate (NOELr) was also 1000 mg.l-1, under the conditions of the test.

 

This guideline, GLP-compliant study has been evaluated as being reliable without restriction.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Test date: 20th January 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

USEPA Ecotox Database evaluation: Reliability: 2A: “Remarks: Reliable with restrictions; Acceptable, well-documented publication report which meets basic scientific principles”

Justification for type of information:

Read across Justification is attached in section 13.

Principles of method if other than guideline:

Guideline: Not specified.

GLP compliance:

not specified

Specific details on test material used for the study:

Purity 97%

Analytical monitoring:

yes

Remarks:

Gas-Liquid Chromatography

Vehicle:

not specified

Details on test solutions:

Toxicant Stock: 90.4 g/L Diluted (Stirred)

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead Minnow
- Age at study initiation (mean and range, SD): 30 d
- Length at study initiation: 18.1 mm (mean); 0.788 mm (SD)
- Weight at study initiation: 0.083 g (mean); 0.0083 g (SD)
- Loading: 0.1153 g/L/d
- Source: Cultured at the U.S. EPA Environmental Laboratory-Duluth or the University of Wisconsin-Superior campus (both used identical culturing methods).

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Not given

Test temperature:

25.7°C

pH:

7.8

Dissolved oxygen:

7.3 mg/L

Salinity:

n/a

Conductivity:

Not given

Nominal and measured concentrations:

Nominal: Control (0 g/L); 7.30, 11.2, 17.3, 26.6 and 40.9 g/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 fish/concentration
- tank volume (l): 1.0 (additions 14.4 v/d)
- pH: the pH of the stock solution (90.4 mg/l) was adjusted to that of lake water using HCl.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 11 800 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Remarks on result:

other: Conf. Lim: 10600 -13000 g/L

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

7 300 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

Affected fish lost schooling behaviour, were hypoactive and darkly coloured, had increased respiration and lost equilibrium prior to death. Hardness and alkalinity values were not recorded. Samples were not taken at 96 h for determination of toxicant concentrations. The pH of the stock solution was adjusted to that of lake water using HCl.

Sublethal observations / clinical signs:

	Toxicant Concentrations (g/L)
Date	Control	A	B	C	D	E
Nominal:	0	7.3	11.2	17.3	26.6	40.9
01/20/87	<0.02	6.42	10.4	16.2	26.4	41.8
01/21/87	<0.02	6.21	10.2	16.2	25.8	40.1
01/22/87	<0.02	6.53	10.7	16.4	27.0	40.7
01/23/87	<0.02	7.16	11.0	17.1	25.6	40.9
01/24/87
Average	<0.02	6.58	10.6	16.5	26.2	40.9
Cor Ave	<0.02	6.14	9.86	15.4	24.4	38.1
Percent Recovery	107.2 (3.8) N=4

	Mortalities
Hour	Control	A	B	C	D	E
Initial	20	20	20	20	20	20
24			1	15	20	20
48			3	17	20	20
72			4	18	20	20
96			4	18	20	20

	Effects
Hour	Control		B	C	D	E
Initial	20	20	20	20	20	20
24			1	15	20	20
48			3	17	20	20
72			4	18	20	20
96			4	18	20	20

Validity criteria fulfilled:

yes

Conclusions:

In a study conducted with Pimephales promelas the 96 h LC50 was calculated to be 11800 mg/L (nominal). The following results were obtained:
96 h LC50 = 11800 mg/L (Conf. Lim. 10600 -13000 mg/L)
96 h NOEC 7300 mg/L

Executive summary:

In a study conducted with Pimephales promelas the 96h LC50 was calculated to be 11800 mg/L. The study was considered to be well documented and to meet generally accepted scientific principles, and should be considered acceptable for assessment.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

USEPA Ecotox Database evaluation: Reliability: 2A: “Remarks: Reliable with restrictions; Acceptable, well-documented publication report which meets basic scientific principles”

Justification for type of information:

Read across Justification is attached in section 13.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

Guideline: Not specified.

GLP compliance:

not specified

Specific details on test material used for the study:

Purity 97%

Analytical monitoring:

yes

Remarks:

Gas-Liquid Chromatography

Vehicle:

not specified

Details on test solutions:

Toxicant Stock: 90.4 g/L Diluted (Stirred)

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead Minnow
- Age at study initiation (mean and range, SD): 30 d
- Length at study initiation: 18.1 mm (mean); 0.788 mm (SD)
- Weight at study initiation: 0.083 g (mean); 0.0083 g (SD)
- Loading: 0.1153 g/L/d
- Source: Cultured at the U.S. EPA Environmental Laboratory-Duluth or the University of Wisconsin-Superior campus (both used identical culturing methods).

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Not given

Test temperature:

25.7°C

pH:

7.8

Dissolved oxygen:

7.3 mg/L

Salinity:

n/a

Conductivity:

Not given

Nominal and measured concentrations:

Nominal: Control (0 g/L); 7.30, 11.2, 17.3, 26.6 and 40.9 g/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 fish/concentration
- tank volume (l): 1.0 (additions 14.4 v/d)
- pH: the pH of the stock solution (90.4 mg/l) was adjusted to that of lake water using HCl.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 11 800 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Remarks on result:

other: Conf. Lim: 10600 -13000 g/L

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

7 300 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

Affected fish lost schooling behaviour, were hypoactive and darkly coloured, had increased respiration and lost equilibrium prior to death. Hardness and alkalinity values were not recorded. Samples were not taken at 96 h for determination of toxicant concentrations. The pH of the stock solution was adjusted to that of lake water using HCl.

Sublethal observations / clinical signs:

	Toxicant Concentrations (g/L)
Date	Control	A	B	C	D	E
Nominal:	0	7.3	11.2	17.3	26.6	40.9
01/20/87	<0.02	6.42	10.4	16.2	26.4	41.8
01/21/87	<0.02	6.21	10.2	16.2	25.8	40.1
01/22/87	<0.02	6.53	10.7	16.4	27.0	40.7
01/23/87	<0.02	7.16	11.0	17.1	25.6	40.9
01/24/87
Average	<0.02	6.58	10.6	16.5	26.2	40.9
Cor Ave	<0.02	6.14	9.86	15.4	24.4	38.1
Percent Recovery	107.2 (3.8) N=4

	Mortalities
Hour	Control	A	B	C	D	E
Initial	20	20	20	20	20	20
24			1	15	20	20
48			3	17	20	20
72			4	18	20	20
96			4	18	20	20

	Effects
Hour	Control		B	C	D	E
Initial	20	20	20	20	20	20
24			1	15	20	20
48			3	17	20	20
72			4	18	20	20
96			4	18	20	20

Validity criteria fulfilled:

yes

Conclusions:

In a study conducted with Pimephales promelas the 96 h LC50 was calculated to be 11800 mg/L (nominal). The following results were obtained:
96 h LC50 = 11800 mg/L (Conf. Lim. 10600 -13000 mg/L)
96 h NOEC 7300 mg/L

Executive summary:

In a study conducted with Pimephales promelas the 96h LC50 was calculated to be 11800 mg/L. The study was considered to be well documented and to meet generally accepted scientific principles, and should be considered acceptable for assessment.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Description of key information

The acute toxicity of the target substance, TOFA, compounds with triethanolamine, to fish, was assessed by read-across from its components, tall oil & triethanolamine. Based on read-across data obtained, the target substance is not expected to be hazardous to fish, with the lowest measured 96 -h LL50 > 1000 mg/L. The read-across justification document covering this and other endpoints is attached in Section 13.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 000 mg/L