Fatty acids, tall-oil, compds. with triethanolamine

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:

key study

Study period:

12th April 2001 - 14th June 2002

Reliability:

1 (reliable without restriction)

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 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

maximum temperature during the definitive test was slightly outside the protocol range, and was therefore logged as a protocol deviaiton - but this was not regarded as affecting the validity of the test.

Qualifier:

according to guideline

Guideline:

other: OECD Paris (2000) Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment, No. 23. ENV/JM/MONO 6.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Test material: Fatty acids, tall oil (CAS No. 61790-12-3)
- Source: Pine Chemicals Association, Inc.
- Appearence: Viscous brown liquid
- Batch No.of test material: 5-10-00-17 (Definitive Test)
- Expiration date of the batch: 23rd March 2006 (Range Finding Test); 15th May 2006 (Definitive Test)
- Purity test date: No Certificate of Analysis or details regarding test item purity were supplied. Study conducted using the test substance as received.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Under ambient conditions in the dark.

Analytical monitoring:

no

Details on sampling:

- No sampling was performed for this study.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The Water Accommodated Fraction (WAF) was prepared in 2 litre capacity glass vessels with sidearm, with 2 litres of ASTM Daphnia medium. Vessels were placed on a magnetic stirrer and a stir bar added. The appropriate weight of test item was added to each vessel, the vessels then sealed to avoid loss of any volatile fractions. The stir bars speed were adjusted to give a stirring vortex of 5-10% of the water column. After an approximate 48-h stirring period, test solutions were allowed to settle for approximately 1-h and the aqueous phase removed via a glass siphon taking care no to remove any undissolved material form the top or bottom of the water column. The first ca.100ml of siphoned medium was discarded before ca. 800ml 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 were exposed to the WAF.

- Differential loading: Definitive-limit test was conducted with WAF prepared from an initial loading rate of 1000 mg.l-1, with an untreated control. this test was conducted using unfiltered WAF and with no pH adjustments.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea (Daphnia Magna)
- Source: Bred within the laboratory by acyclical parthenogenesis. Neonates used were <24h old. Daphnia cultures were maintained in ASTM, a synthetic medium. MEDIUM..
- Feeding during test: Daphnia were not fed during the test. When not testing Daphnia cultures were fed on a diet of axenic cultures of Selenastrum capricornutum (Strain 278/4, CCAP, Ambleside, Cumbria).

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

176 mg CaCO3 l-1 (at commencement of the definitive-limit test).

Test temperature:

21.0 - 22.2°C (definitive-limit test). The maximum recorded temperature was slightly outside protocol specifications and was recorded accordingly as a protocol deviation. This deviation was not considered to have affected the validity of the study.

pH:

7.08 - 8.20 (definitive-limit test).

Dissolved oxygen:

80.9 - 92.5% (definitive-limit test).

Conductivity:

0.56 - 0.59 mS (definitive-limit test).

Nominal and measured concentrations:

Four vessels were prepared for 1000 mg.l-1 and the untreated control, with each vessel containing 100 ml WAF medium (test or control) and 5 daphnia. Concentrations were tested as nominal as no analytical analysis was performed.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass crystallising dishes (capacity ca. 200 ml) covered with perspex lids to prevent contamination and evaporation.
- Type: closed
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 100 ml of WAF medium (test or control)

TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: 0, 24 and 48h.

OTHER TEST CONDITIONS
- Adjustment of pH: None in the definitive-limit test.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 48h EL50 and 48h NOELr.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: The initial loading rates were 1000, 100, 10, 1 and 0 mg.l-1. The dose range finding study was conducted under static condition for a duration of 48-hrs using medium prepared as WAF. At the highest loading rate further WAF treatment was undertaken to evaluate a filtered and pH adjusted test solution against the standard WAF.
- Results used to determine the conditions for the definitive study: After 48h, 2 immobile Daphnia were observed at 1 mg.l-1 and 4 immobile Daphnia were observed in the control group (0 mg/l.-1). As the observed deaths (immobilisation) only occurred in single replicates they are not considered as test item related. No further immobile Daphnia or other effects were observed at any other test level.

Reference substance (positive control):

not required

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: None
- Mortality of control: None.

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

		Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)
Time (h)	Tank Replicate	1000	0
24	A	0/5	0/5
24	B	0/5	0/5
24	C	0/5	0/5
24	D	0/5	0/5
24	% Immobile Daphnia	0	0
48	A	0/5	0/5
48	B	0/5	0/5
48	C	0/5	0/5
48	D	0/5	0/5
48	% Immobile Daphnia	0	0

Water Quality Parameters Recorded at 0 and 48h During the Definitive-Limit Test

	Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)
Time/Parameter	1000	0
At 0 h
pH	7.08	7.97
Temperature (°C)	22.2	22.2
Conductivity (mS)	0.57	0.59
Dissolved Oxygen (%)	83.5	92.5
At 24h
pH	8.15	8.20
Temperature (°C)	21.0	21.2
Conductivity (mS)	0.57	0.59
Dissolved Oxygen (%)	87.8	87.6
At 48h
pH	8.07	8.16
Temperature (°C)	21.6	21.5
Conductivity (mS)	0.56	0.57
Dissolved Oxygen (%)	80.9	84.0

Validity criteria fulfilled:

not specified

Remarks:

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

Conclusions:

No mortality or other effects were observed in the Daphnia during the study. The 48h EL50 was >1000 mg.l-1, the highest loading rate tested. The No Observed Effect Loading Rate (NOELr) was 1000 mg.l-1.

Executive summary:

The study was designed to determine the median effective loading (EL50) of Fatty acids, Tall oil, CAS No. 61790 -12 -3, by exposing Daphnia under static conditions to solutions prepared as Water Accomodated Fractions (WAF) at different loading rates; and was performed based on procedures in OECD (1984) Guideline 202, 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: 7.08 -8.20, dissolved oxygen: 80.9 -92.5%, temperature: 21.0 -22.2°C and conductivity 0.56 -0.59 mS.

No mortality or other effects were observed in the Daphnia during the study. The 48h EL50 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 aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

12th April 2001 - 14th 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

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

maximum temperature during the definitive test was slightly outside the protocol range, and was therefore logged as a protocol deviaiton - but this was not regarded as affecting the validity of the test.

Qualifier:

according to guideline

Guideline:

other: OECD Paris (2000) Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures. OECD Series on Testing and Assessment, No. 23. ENV/JM/MONO 6.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Test material: Fatty acids, tall oil (CAS No. 61790-12-3)
- Source: Pine Chemicals Association, Inc.
- Appearence: Viscous brown liquid
- Batch No.of test material: 5-10-00-17 (Definitive Test)
- Expiration date of the batch: 23rd March 2006 (Range Finding Test); 15th May 2006 (Definitive Test)
- Purity test date: No Certificate of Analysis or details regarding test item purity were supplied. Study conducted using the test substance as received.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Under ambient conditions in the dark.

Analytical monitoring:

no

Details on sampling:

- No sampling was performed for this study.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The Water Accommodated Fraction (WAF) was prepared in 2 litre capacity glass vessels with sidearm, with 2 litres of ASTM Daphnia medium. Vessels were placed on a magnetic stirrer and a stir bar added. The appropriate weight of test item was added to each vessel, the vessels then sealed to avoid loss of any volatile fractions. The stir bars speed were adjusted to give a stirring vortex of 5-10% of the water column. After an approximate 48-h stirring period, test solutions were allowed to settle for approximately 1-h and the aqueous phase removed via a glass siphon taking care no to remove any undissolved material form the top or bottom of the water column. The first ca.100ml of siphoned medium was discarded before ca. 800ml 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 were exposed to the WAF.

- Differential loading: Definitive-limit test was conducted with WAF prepared from an initial loading rate of 1000 mg.l-1, with an untreated control. this test was conducted using unfiltered WAF and with no pH adjustments.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea (Daphnia Magna)
- Source: Bred within the laboratory by acyclical parthenogenesis. Neonates used were <24h old. Daphnia cultures were maintained in ASTM, a synthetic medium. MEDIUM..
- Feeding during test: Daphnia were not fed during the test. When not testing Daphnia cultures were fed on a diet of axenic cultures of Selenastrum capricornutum (Strain 278/4, CCAP, Ambleside, Cumbria).

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

176 mg CaCO3 l-1 (at commencement of the definitive-limit test).

Test temperature:

21.0 - 22.2°C (definitive-limit test). The maximum recorded temperature was slightly outside protocol specifications and was recorded accordingly as a protocol deviation. This deviation was not considered to have affected the validity of the study.

pH:

7.08 - 8.20 (definitive-limit test).

Dissolved oxygen:

80.9 - 92.5% (definitive-limit test).

Conductivity:

0.56 - 0.59 mS (definitive-limit test).

Nominal and measured concentrations:

Four vessels were prepared for 1000 mg.l-1 and the untreated control, with each vessel containing 100 ml WAF medium (test or control) and 5 daphnia. Concentrations were tested as nominal as no analytical analysis was performed.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass crystallising dishes (capacity ca. 200 ml) covered with perspex lids to prevent contamination and evaporation.
- Type: closed
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 100 ml of WAF medium (test or control)

TEST MEDIUM / WATER PARAMETERS
- Intervals of water quality measurement: 0, 24 and 48h.

OTHER TEST CONDITIONS
- Adjustment of pH: None in the definitive-limit test.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 48h EL50 and 48h NOELr.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: The initial loading rates were 1000, 100, 10, 1 and 0 mg.l-1. The dose range finding study was conducted under static condition for a duration of 48-hrs using medium prepared as WAF. At the highest loading rate further WAF treatment was undertaken to evaluate a filtered and pH adjusted test solution against the standard WAF.
- Results used to determine the conditions for the definitive study: After 48h, 2 immobile Daphnia were observed at 1 mg.l-1 and 4 immobile Daphnia were observed in the control group (0 mg/l.-1). As the observed deaths (immobilisation) only occurred in single replicates they are not considered as test item related. No further immobile Daphnia or other effects were observed at any other test level.

Reference substance (positive control):

not required

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: None
- Mortality of control: None.

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

		Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)
Time (h)	Tank Replicate	1000	0
24	A	0/5	0/5
24	B	0/5	0/5
24	C	0/5	0/5
24	D	0/5	0/5
24	% Immobile Daphnia	0	0
48	A	0/5	0/5
48	B	0/5	0/5
48	C	0/5	0/5
48	D	0/5	0/5
48	% Immobile Daphnia	0	0

Water Quality Parameters Recorded at 0 and 48h During the Definitive-Limit Test

	Initial Loading Rates of Fatty acids, tall oil (mg.l^-1)
Time/Parameter	1000	0
At 0 h
pH	7.08	7.97
Temperature (°C)	22.2	22.2
Conductivity (mS)	0.57	0.59
Dissolved Oxygen (%)	83.5	92.5
At 24h
pH	8.15	8.20
Temperature (°C)	21.0	21.2
Conductivity (mS)	0.57	0.59
Dissolved Oxygen (%)	87.8	87.6
At 48h
pH	8.07	8.16
Temperature (°C)	21.6	21.5
Conductivity (mS)	0.56	0.57
Dissolved Oxygen (%)	80.9	84.0

Validity criteria fulfilled:

not specified

Remarks:

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

Conclusions:

No mortality or other effects were observed in the Daphnia during the study. The 48h EL50 was >1000 mg.l-1, the highest loading rate tested. The No Observed Effect Loading Rate (NOELr) was 1000 mg.l-1.

Executive summary:

The study was designed to determine the median effective loading (EL50) of Fatty acids, Tall oil, CAS No. 61790 -12 -3, by exposing Daphnia under static conditions to solutions prepared as Water Accomodated Fractions (WAF) at different loading rates; and was performed based on procedures in OECD (1984) Guideline 202, 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: 7.08 -8.20, dissolved oxygen: 80.9 -92.5%, temperature: 21.0 -22.2°C and conductivity 0.56 -0.59 mS.

No mortality or other effects were observed in the Daphnia during the study. The 48h EL50 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 aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Protocol referenced as: Warne, M. St. J., and Julli, M. Protocol for acute and chronic toxicity tests using the cladocerans Ceriodaphnia cf. dubia Richard and Daphnia carinata King. New South Wales Environment Protection Authority, in press. Guidance is a national australian guideline and is considered appliable to standard guidance.

Justification for type of information:

Read across justification is attached in section 13

Qualifier:

according to guideline

Guideline:

other: Protocol referenced as: Warne, M. St. J., and Julli, M. Protocol for acute and chronic toxicity tests using the cladocerans Ceriodaphnia cf. dubia Richard and Daphnia carinata King. New South Wales Environment Protection Authority, in press

Version / remarks:

Guidance is a national Australian guideline and is considered appliable to standard guidance.

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

ASTM (1988). Standard Guide for Conducting Acute Toxicity Tests on Aqueous E/uents with Fishes, Macroinvertebrates, and Amphibians. American Society for Testing and Materials. Designation E1192.

Principles of method if other than guideline:

ASTM (1988). Standard Guide for Conducting Acute Toxicity Tests on Aqueous E/uents with Fishes, Macroinvertebrates, and Amphibians. American Society for Testing and Materials. Designation E1192.

Guidance is a national Australian guideline and is considered appliable to standard guidance.

GLP compliance:

not specified

Specific details on test material used for the study:

-Test substance name: Triethanolamine
- Source and lot/batch No.of test material: Not stated
- Purity: No data
- Storage: All components were stored in the dark at 22±2°C.
- Expiration date of the lot/batch: Not stated

Analytical monitoring:

not specified

Details on test solutions:

Stock solutions of each component (except the enzymes), were made by dissolving the appropriate amount in 1 or 2 L of the water described previously and then gently stirred for 12 h in the dark at 23±1°C using Teflon magnetic stirrers. Stock solutions of the enzymes were made immediately prior to commencing the bioassays and were stirred for a maximum of 15 min. Stirring was conducted so that no bubbles were formed when the surfactants were dissolved, as the formation of bubbles leads to depletion of surfactants in the solution (Aboul-Kassim and Simoneit, 1993). Light was excluded during the stirring to minimize photodegradation of the chemicals. Stock solutions were diluted to the appropriate concentrations immediately prior to the commencement of a test.

Ref: Aboul-Kassim, T. A., and Simoneit, B. R. T. (1993). Detergents: A review of the nature, chemistry and behavior in the aquatic environment: Part 1. Chemical composition and analytical techniques. Crit. Rev. Environ. Sci. & Technol. 24, 325-346.

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Strain/clone: The cladoceran used in this study was identified as C. dubia Richard (Julli et al., 1990). However, while the cladoceran conforms (cf.) to the description of C. dubia it was not identical and to denote that it may be a different species it has been called C. cf. dubia.
- Source: C. cf. dubia were cultured and tested at 23±1°C in dechlorinated Sydney mains water which was filtered (1 µm), aged (1 month), and adjusted to 500µS/cm with seawater.
- Cultures of C. cf. dubia were maintained in 2 L glass beakers and transferred to fresh water three times weekly.
- Food was provided after water renewal at a concentration of 25,000 cells/mL of each of the unicellular algae Pseudokirchneriella subcapitata Printz (formerly named Selenastrum capricornutum) and Ankistrodesmus sp.
- All neonates used in the toxicity tests were less than 24 h old.
- Animals were not fed during the tests.
Ref: Julli, M., Chapman, J., and Thomson, G. T. (1990). Use of Australian cladocerans to generate life-cycle toxicity data. Environ. Monitor Assess. 14, 353-362.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

Tests were terminated after 48 h and the numbers of immobile cladocera counted. Immobilization was defined as the absence of visible movement by the cladocera within 15 s of gentle agitation of the test solution (ASTM, 1988).

Hardness:

Not specified.

Test temperature:

Beakers were randomly positioned in constant temperature cabinets and maintained at 23±1°C

pH:

Measured immediately prior to the addition of the cladocera and on completion of each bioassay. Values not specified.

Dissolved oxygen:

Measured immediately prior to the addition of the cladocera and on completion of each bioassay. Values not specified.

Conductivity:

Measured immediately prior to the addition of the cladocera and on completion of each bioassay. Values not specified.

Nominal and measured concentrations:

Each bioassay consisted of five concentrations of a detergent component arranged in a geometric series, plus a control.

Details on test conditions:

TEST SYSTEM
- Test vessel: The test vessels were 250 mL glass beakers which held 200 mL of the test solution or control solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 3
- Biomass loading rate: 1 animal / 40 mL

OTHER TEST CONDITIONS
- Photoperiod: 16:8 h light to dark cycle
- Light intensity: Below 1000 Lux at the surface of the solutions

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 48 h EC50 (number of immobile cladocera counted at the end of test). Temperature, dissolved oxygen, pH, and conductivity of the test solutions were measured immediately prior to the addition of the cladocera and on completion of each bioassay.

RANGE-FINDING STUDY
- Triethanolamine was tested in a range-finder and definitive test over the period of the study.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

609.98 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mobility

Remarks on result:

other: 95% CL: 565.2 - 658.3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.089 mmol/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mobility

Remarks on result:

other: 95% CL: 3.79 - 4.41

Reported statistics and error estimates:

The 48-h EC50 (immobilization) values and 95% confidence intervals were based on nominal concentrations and were determined by the trimmed Spearman-Karber method (Hamilton et al., 1977). The toxicity of the components was expressed in three different units: EC50 mg/L, EC50 mmol/L, and toxic units (mean % detergent toxicity range).

Ref: Hamilton, M. A., Russo, R. C., and Thurston, R. V. (1977). Trimmed Spearman}Karber method for estimating median lethal concentrations in toxicity bioassays. Environ. Sci. Technol. 11, 714-719. Correction (1978). 12, 417.

Component Name and Number, CAS Number, Molecular Weight, Toxicity Values (EC50) Expressed in mg/L and mmol/L and

the Percentage of Toxicity the Component Contributes to the Toxicity of the Detergent

 

Component number and name	CAS No.	MWb	EC50 mg/L (95% CL))	EC50 (mmol/L) (95% CL)	Mean % detergent toxicity (range)
Triethanolamine	102-71-6	149.19	609.98 (565.2 - 658.3)	4.0886 (3.79 - 4.41)	0.02

 

 

Validity criteria fulfilled:

yes

Conclusions:

The 48-h EC50 (immobilisation) value from a static acute toxicity test with was calculated as 609.88 mg/L based on nominal concentrations.

Executive summary:

The 48 -h EC50 (immobilisation) value from the static acute toxicity test with Ceriodaphnia dubia was calculated as 609.88 mg/L based on nominal concentrations. The test procedure is in accordance with national standard methods with acceptable restrictions.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Protocol referenced as: Warne, M. St. J., and Julli, M. Protocol for acute and chronic toxicity tests using the cladocerans Ceriodaphnia cf. dubia Richard and Daphnia carinata King. New South Wales Environment Protection Authority, in press. Guidance is a national australian guideline and is considered appliable to standard guidance.

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:

other: Protocol referenced as: Warne, M. St. J., and Julli, M. Protocol for acute and chronic toxicity tests using the cladocerans Ceriodaphnia cf. dubia Richard and Daphnia carinata King. New South Wales Environment Protection Authority, in press

Version / remarks:

Guidance is a national Australian guideline and is considered appliable to standard guidance.

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

ASTM (1988). Standard Guide for Conducting Acute Toxicity Tests on Aqueous E/uents with Fishes, Macroinvertebrates, and Amphibians. American Society for Testing and Materials. Designation E1192.

GLP compliance:

not specified

Specific details on test material used for the study:

-Test substance name: Triethanolamine
- Source and lot/batch No.of test material: Not stated
- Purity: No data
- Storage: All components were stored in the dark at 22±2°C.
- Expiration date of the lot/batch: Not stated

Analytical monitoring:

not specified

Details on test solutions:

Stock solutions of each component (except the enzymes), were made by dissolving the appropriate amount in 1 or 2 L of the water described previously and then gently stirred for 12 h in the dark at 23±1°C using Teflon magnetic stirrers. Stock solutions of the enzymes were made immediately prior to commencing the bioassays and were stirred for a maximum of 15 min. Stirring was conducted so that no bubbles were formed when the surfactants were dissolved, as the formation of bubbles leads to depletion of surfactants in the solution (Aboul-Kassim and Simoneit, 1993). Light was excluded during the stirring to minimize photodegradation of the chemicals. Stock solutions were diluted to the appropriate concentrations immediately prior to the commencement of a test.

Ref: Aboul-Kassim, T. A., and Simoneit, B. R. T. (1993). Detergents: A review of the nature, chemistry and behavior in the aquatic environment: Part 1. Chemical composition and analytical techniques. Crit. Rev. Environ. Sci. & Technol. 24, 325-346.

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Strain/clone: The cladoceran used in this study was identified as C. dubia Richard (Julli et al., 1990). However, while the cladoceran conforms (cf.) to the description of C. dubia it was not identical and to denote that it may be a different species it has been called C. cf. dubia.
- Source: C. cf. dubia were cultured and tested at 23±1°C in dechlorinated Sydney mains water which was filtered (1 µm), aged (1 month), and adjusted to 500µS/cm with seawater.
- Cultures of C. cf. dubia were maintained in 2 L glass beakers and transferred to fresh water three times weekly.
- Food was provided after water renewal at a concentration of 25,000 cells/mL of each of the unicellular algae Pseudokirchneriella subcapitata Printz (formerly named Selenastrum capricornutum) and Ankistrodesmus sp.
- All neonates used in the toxicity tests were less than 24 h old.
- Animals were not fed during the tests.
Ref: Julli, M., Chapman, J., and Thomson, G. T. (1990). Use of Australian cladocerans to generate life-cycle toxicity data. Environ. Monitor Assess. 14, 353-362.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

Tests were terminated after 48 h and the numbers of immobile cladocera counted. Immobilization was defined as the absence of visible movement by the cladocera within 15 s of gentle agitation of the test solution (ASTM, 1988).

Hardness:

Not specified.

Test temperature:

Beakers were randomly positioned in constant temperature cabinets and maintained at 23±1°C

pH:

Measured immediately prior to the addition of the cladocera and on completion of each bioassay. Values not specified.

Dissolved oxygen:

Measured immediately prior to the addition of the cladocera and on completion of each bioassay. Values not specified.

Conductivity:

Measured immediately prior to the addition of the cladocera and on completion of each bioassay. Values not specified.

Nominal and measured concentrations:

Each bioassay consisted of five concentrations of a detergent component arranged in a geometric series, plus a control.

Details on test conditions:

TEST SYSTEM
- Test vessel: The test vessels were 250 mL glass beakers which held 200 mL of the test solution or control solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 3
- Biomass loading rate: 1 animal / 40 mL

OTHER TEST CONDITIONS
- Photoperiod: 16:8 h light to dark cycle
- Light intensity: Below 1000 Lux at the surface of the solutions

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 48 h EC50 (number of immobile cladocera counted at the end of test). Temperature, dissolved oxygen, pH, and conductivity of the test solutions were measured immediately prior to the addition of the cladocera and on completion of each bioassay.

RANGE-FINDING STUDY
- Triethanolamine was tested in a range-finder and definitive test over the period of the study.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

609.98 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mobility

Remarks on result:

other: 95% CL: 565.2 - 658.3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.089 mmol/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mobility

Remarks on result:

other: 95% CL: 3.79 - 4.41

Reported statistics and error estimates:

The 48-h EC50 (immobilization) values and 95% confidence intervals were based on nominal concentrations and were determined by the trimmed Spearman-Karber method (Hamilton et al., 1977). The toxicity of the components was expressed in three different units: EC50 mg/L, EC50 mmol/L, and toxic units (mean % detergent toxicity range).

Ref: Hamilton, M. A., Russo, R. C., and Thurston, R. V. (1977). Trimmed Spearman}Karber method for estimating median lethal concentrations in toxicity bioassays. Environ. Sci. Technol. 11, 714-719. Correction (1978). 12, 417.

Component Name and Number, CAS Number, Molecular Weight, Toxicity Values (EC50) Expressed in mg/L and mmol/L and

the Percentage of Toxicity the Component Contributes to the Toxicity of the Detergent

 

Component number and name	CAS No.	MWb	EC50 mg/L (95% CL))	EC50 (mmol/L) (95% CL)	Mean % detergent toxicity (range)
Triethanolamine	102-71-6	149.19	609.98 (565.2 - 658.3)	4.0886 (3.79 - 4.41)	0.02

 

 

Validity criteria fulfilled:

yes

Conclusions:

The 48-h EC50 (immobilisation) value from a static acute toxicity test with was calculated as 609.88 mg/L based on nominal concentrations.

Executive summary:

The 48 -h EC50 (immobilisation) value from the static acute toxicity test with Ceriodaphnia dubia was calculated as 609.88 mg/L based on nominal concentrations. The test procedure is in accordance with national standard methods with acceptable restrictions.

Description of key information

The acute toxicity of the target substance, TOFA, compounds with triethanolamine, to Daphina, 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 Daphina, with the lowest measured 48 hr 609.98 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 invertebrates

Fresh water invertebrates

Effect concentration:

609.98 mg/L