Carboxylic acids, C5-9, triesters with 2-ethyl-2-(hydroxymethyl)propane-1,3-diol

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:

1995

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)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples for analysis were taken at 0, 24, 48, 72 and 96 hours old and new for all concentrations. A sample of the stock was also taken each day. Analysis indicated that mean measured concentrations were between 68 and 70 % of nominal over the duration of the test

Vehicle:

no

Details on test solutions:

At 0 hours 3.2 g of Priolube 3934 (Q038-03) was weighed out and dispersed in 5 Iitres of carbon filtered tap water by high-shear mixing at 20,000 rpm for 30
minutes in a 5 litre conical flask to maximize the shearing effect of the blade. This gave a 640 mg/I stock. This stock was prepared daily with the test solutions
prepared by appropriate dilution of the stock as outlined in Table 1 (see below)

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The fish used in this study were taken from batch 36Z which hatched on 17/3/95.
They were reared in carbon-filtered tap water and fed on proprietary fish food.
There were no significant mortalities of the test fish in the week prior to the test.
A fish survey was carried out at the end of the test. Fish from the control tank indicated a mean weight of 0.20 g and a mean length of 3.1 cm.
In a deviation from SOP 108 04 not all of the fish surveyed were 2.0 ± 1.0 cm in length. This is not considered to have affected the outcome of the study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

See table 2

Test temperature:

See table 2

pH:

See table 2

Dissolved oxygen:

See table 2

Nominal and measured concentrations:

See table 3

Details on test conditions:

The method was a static renewal procedure with test renewals every 24 hours. The test vessels were 6 litre capacity all-glass tanks containing 5 Iitres of test solution.
There were no replicates and all vessels were aerated. The fish were observed daily for any abnormalities in swimming activity and loss of balance.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 124 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities at any of the test concentrations. There were no visible abnormalities, and fish behaviour was unaffected at any of the test concentrations.

Validity criteria fulfilled:

yes

Conclusions:

Priolube 3934 is not acutely toxic to Zebra fish at a mean measured concentration of 124 mg/1. The 96 hour LC50 is greater than 124 mg/1. Observations of the fish
indicated that fish behaviour was not affected and there were no visible abnormalities at the tested concentrations. The 96 hour NOEC is > 124 mg/l.
LC50 (96h) >124 mg/L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

other: Read across on analogous substance

Adequacy of study:

supporting study

Study period:

1995

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)

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples for analysis were taken at 0, 24, 48, 72 and 96 hours old and new for all concentrations. A sample of the stock was also taken each day. Analysis indicated that mean measured concentrations were between 27 and 36 % of nominal over the duration of the test

Vehicle:

no

Details on test solutions:

At 0 hours 3.2 g of the substance was weighed out and dispersed in 5 litres of carbon filtered tap water by high-shear mixing at 15,000 rpm for 30
minutes in a 5 litre conical flask to maximize the shearing effect of the blade. This gave a 640 mg/I stock. This stock was prepared daily with the test solutions prepared by appropriate dilution of the stock as outlined in Table 1. (see below)

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The fish used in this study were taken from batch 36Z which hatched on 17/3/95.
They were reared in carbon-filtered tap water and fed on proprietary fish food.
There were no significant mortalities of the test fish in the week prior to the test.
A fish survey was carried out at the end of the test. Fish from the control tank indicated a mean weight of 0.20 g and a mean length of 3.1 cm.
In a deviation from SOP 108 04 not all of the fish surveyed were 2.0 ± 1.0 cm in length. This is not considered to have affected the outcome of the study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

See table 2

Test temperature:

See table 2

pH:

See table 2

Dissolved oxygen:

See table 2

Nominal and measured concentrations:

Nominal: 0, 18, 32, 56, 100 and 180 mg/L
Measured: 0, 6.5, 9.7, 16.1, 27.8 and 48.3 mg/L
See table 3

Details on test conditions:

The method was a static renewal procedure with test renewals every 24 hours. The test vessels were 6 litre capacity all-glass tanks containing 5 Iitres of test solution.
There were no replicates and all vessels were aerated. The fish were observed daily for any abnormalities in swimming activity and loss of balance.

TEST SYSTEM
- Test vessel:
- Material, size, fill volume: 6 L all-glass tanks containing 5 L of test solution
- Aeration: yes
- Renewal rate of test solution (frequency): every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Carbon filtered tap water
- Intervals of water quality measurement: Daily for pH, dissolved oxygen, total hardness and temperature.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/ 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities and symptoms of toxicity were determined daily. The fish from the control were weighed and measured at the end of the exposure period

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 48 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities at any of the test concentrations. There were no visible abnormalities, and fish behaviour was unaffected at any of the test concentrations.

Validity criteria fulfilled:

yes

Conclusions:

Priolube 3988 is not acutely toxic to Zebra fish at a mean measured concentration of 48 mg/l. The 96 hour LC50 is greater than 48 mg/l. Observations of the fish
indicated that fish behaviour was not affected and there were no visible abnormalities at the tested concentrations. The 96 hour NOEC is > 48 mg/l.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

no guideline required

Principles of method if other than guideline:

Ecosar v1.00, integrated in EpiSuite was used.

GLP compliance:

no

Test organisms (species):

other: fish

Test type:

other: (Q)SAR evaluation

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.008 mg/L

Nominal / measured:

estimated

Conc. based on:

other: QSAR

Basis for effect:

mortality (fish)

Remarks on result:

other: The QSAR model indicates that the chemical may not be soluble enough to measure this predicted effect.

Details on results:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 5.289 e-5 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 8.674.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Sublethal observations / clinical signs:

Chemical may not be soluble enough to measure this predicted effect.

Conclusions:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is 5.289e-5.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate) . The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 8.674.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

no guideline required

Principles of method if other than guideline:

Ecosar v1.00, integrated in EpiSuite was used.

GLP compliance:

no

Test organisms (species):

other: fish

Test type:

other: (Q)SAR evaluation

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.004 mg/L

Nominal / measured:

estimated

Conc. based on:

other: QSAR

Basis for effect:

mortality (fish)

Remarks on result:

other: The QSAR model indicates that the chemical may not be soluble enough to measure this predicted effect.

Details on results:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 1.641 e-5 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 9.165.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Sublethal observations / clinical signs:

Chemical may not be soluble enough to measure this predicted effect.

Conclusions:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is 1.641 e-5.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate) . The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 9.165.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

no guideline required

Principles of method if other than guideline:

Ecosar v1.00, integrated in EpiSuite was used.

GLP compliance:

no

Test organisms (species):

other: fish

Test type:

other: (Q)SAR evaluation

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.002 mg/L

Nominal / measured:

estimated

Conc. based on:

other: QSAR

Basis for effect:

mortality (fish)

Remarks on result:

other: The QSAR model indicates that the chemical may not be soluble enough to measure this predicted effect.

Details on results:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 5.084 e-6 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 9.656.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Sublethal observations / clinical signs:

Chemical may not be soluble enough to measure this predicted effect.

Conclusions:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 5.084 e-6 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 9.656.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

no guideline required

Principles of method if other than guideline:

Ecosar v1.00, integrated in EpiSuite was used.

GLP compliance:

no

Test organisms (species):

other: fish

Test type:

other: (Q)SAR evaluation

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.001 mg/L

Nominal / measured:

estimated

Conc. based on:

other: QSAR

Basis for effect:

mortality (fish)

Remarks on result:

other: The QSAR model indicates that the chemical may not be soluble enough to measure this predicted effect.

Details on results:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 1.574 e-6 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 10.147.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Sublethal observations / clinical signs:

Chemical may not be soluble enough to measure this predicted effect.

Conclusions:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 1.574 e-6 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 10.147.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Reference 7

Endpoint:

short-term toxicity to fish

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Qualifier:

no guideline required

Principles of method if other than guideline:

Ecosar v1.00, integrated in EpiSuite was used.

GLP compliance:

no

Test organisms (species):

other: fish

Test type:

other: (Q)SAR evaluation

Water media type:

freshwater

Total exposure duration:

96 h

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.001 mg/L

Nominal / measured:

estimated

Conc. based on:

other: QSAR

Basis for effect:

mortality (fish)

Remarks on result:

other: The QSAR model indicates that the chemical may not be soluble enough to measure this predicted effect.

Details on results:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 4.871 e-7 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 10.639.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Sublethal observations / clinical signs:

Chemical may not be soluble enough to measure this predicted effect.

Conclusions:

The water solubility as described in section 4.8 of IUCLID is < 0.04 mg/L. The QSAR estimate for the water solubility predicts that the actual solublity will be far below that value. The predicted water solubility is, in fact, 4.871 e-7 mg/L.
The log Kow of the substance as described in section 4.7 of IUCLID is > 6 (RA from the analogue TMP Pelargonate). The QSAR estimate for the Log Kow predicts that the partition coefficient will be far above that value. The predicted Log Kow is 10.639.

Based on the comparison of the water solubility with the estimated LC50 for fish it is clear that the substance is most likely not soluble enough to result in this predicted QSAR effect. In addition the QSAR model indicates that if the log Kow is > 5, and the LC50 exceeds the water solubility by a factor 10, no effects at saturation are predicted.
This is the case for this substance. Therefore, the conclusion is that no acute toxicity is predicted for this substance.

Reference 8

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:

The read across justification is reported at section 13

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 124 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

Priolube 3934 is not acutely toxic to Zebra fish at a mean measured concentration of 124 mg/1. The 96 hour LC50 is greater than 124 mg/1. Observations of the fish
indicated that fish behaviour was not affected and there were no visible abnormalities at the tested concentrations. The 96 hour NOEC is > 124 mg/l.
LC50 (96h) >124 mg/L

Description of key information

Two studies have been conducted (one on the target substance TMP Pelargonate and one on the analogue TMP Triisostearate) indicating no effect at the maximum tested concentration, equivalent to nominal 180 mg/l. The measured concentrations are much lower due to the water solubility and hydrolytic instability of the substances.

Because no hazard was identified, no key values for chemical safety assessment are given below.

LC0 of TMP tripelargonate > 124 mg/l

LC0 of TMP isotristearate > 48 mg/l

Qsar generated data are also available on short term toxicity for the constituents of this UVCB substance.