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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
Study period:
04 - 09 April 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF) were prepared by stirring the test substance in the dilution water for 24 hours to reach equilibrium
concentration. A 20 L complete glass basin was appointed with a glass tube, by what the aqueous phase could be take off witout contamination of the unsolved film of the hydrocarbon. Before the take off of the aqueous phase the preparation was left for 1 hour for complete phase separation.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: MPI für Entwicklungsbiologie, Tübingen, Germany
- Length at study initiation (length definition, mean, range and SD): 3.1 - 3.5 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: At least 12 d
- Health during acclimation (any mortality observed): Mortality ≤ 5%

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
23 ± 2 °C
pH:
8.2 - 8.4
Dissolved oxygen:
> 91%
Nominal and measured concentrations:
Nominal: 10000 mg/L (WAF)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 10 L/ basin
- Aeration: yes, constant with Pasteur pipettes
- Renewal rate of test solution (frequency): every 24 h
- No. of organisms per concentration: 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: By aeration (1-2 d) dechlorinated tap water
- Intervals of water quality measurement: Oxygen content, pH-value and temperature were registered after 24 h, 48 h, 72 h and 96 h.

OTHER TEST CONDITIONS
- Photoperiod: 14 light, 10 h dark (Gro-Lux)

EFFECT PARAMETERS MEASURED: Schooling behaviour, activity (mobility), surfacing, floatability
(equilibrium behaviour), dead animals, breathing frequency
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: WAF loading rate
Details on results:
- Behavioural abnormalities: 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the school
and showed lower activity. After 72 h the schooling behaviour of the rest of the fish was also disturbed. The activity and the equilibrium behaviour
was equal to the control fish.
- Other biological observations: The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same
behaviour as the control fish.
- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: WAFs showed light turbidity, but
contained no visible emulsion drops.

No mortality of the fish could be observed in the control and the test concentration (10000 mg/l WAF) after 96h under conditions tested. 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the swarm and showed lower activity. But after 72 h the swarm behaviour of the rest of the fish was also disturbed. However, the activity and the equilibrium behaviour was equal to the control fish. The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same behaviour as the control fish. As WAFs showed light turbidity and the water solubility of the test substance is < 0.3 mg/l, the abnormal behaviour could cause in unsolved test substance. Overall no mortality could be observed and therefore the LL50 is > 10000 mg/l. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance were observed and therewith the LC50 (96h) is > water solubility of the test substance.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
Qualifier:
according to
Guideline:
other: OECD series on testing and assessment 23, 2000
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: During the limit test singular samples for possible analysis were taken from the limit concentration and the control at t=0 h, t=24 h, and t=96 h
- Sampling method: 2 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis

Additionally, singular reserve samples of 2 mL were taken from all test solutions for possible analysis. If not already used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with a loading rate of 100 mg/L applying 2 days of magnetic stirring to ensure maximum dissolution in test medium. The resulting dispersion was left to settle for 1 hour (range-finding test) or 2 hours (final limit test) were after the Water Accomodated Fraction (WAF) was collected by siphoning for use as highest test concentration. Note that in the final limit test the WAF was siphoned twice using a tube containing glass wool in the first siphoning step. The lower test concentrations for the range-finding test were prepared by subsequent dilutions in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The final test solutions were clear and colourless in the range-finding test and slightly hazy in the final limit test with a slight floating layer.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Age at study: F1 from a single parent-pair bred in UV-treated water
- Length at study initiation (mean): Range-finding test: 3.3 ± 0.2 cm, Limit test: 3.3 ± 0.1 cm
- Weight at study initiation (mean): Range-finding test: 1.09 ± 0.29 g, Limit test: 0.97 ± 0.06 g
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Type and amount of food: pelleted fish food (Cyprico Crumble Excellent (300-500 µm), Coppens International bv, Helmond, The Netherlands)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
180 mg/L expressed as CaCO3
Test temperature:
21.1 °C - 22.5 °C
pH:
7.3 - 8.0
Dissolved oxygen:
6.4 - 9.1 mg/L
Nominal and measured concentrations:
range finding test: 0.1, 1.0, 10 and 100% of the WAF prepared at a loading rate of 100 mg/L (nominal)
final limit test: control, 100% of the WAF prepared at a loading rate of 100 mg/L (nominal)
final limit test: control, 4.8 mg/L (measured)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: glass vessels, 40-L, 15 L fill volume
- Aeration: no
- No. of organisms per vessel: 3 (range finding test), 7 (final limit test)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.45 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands) with the following composition:
CaCl2.2H2O: 211.5 mg/l
MgSO4.7H2O: 88.8 mg/l
NaHCO: 346.7 mg/l
KCl: 4.2 mg/l
- Intervals of water quality measurement: pH, nitrate, nitrite and ammonia concentration: once a week. Temperature: continuous. In addition, pH and temperature were measured before transferring the fish to the test system

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 16 hours light, 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observation for any dead or severely distressed fish at 2.25, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10 (range-finding test)
- Justification for using less concentrations than requested by guideline: No mortality or clinical effects were observed at any of the test concentrations during the test period
- Range finding study
- Test concentrations: 0.1, 1.0, 10 and 100% of the WAF
- Results used to determine the conditions for the definitive study: No mortality or clinical effects were observed at any of the test concentrations during the test period. Based on these results samples taken from the WAF prepared at 100 mg/L were analysed. The initial concentration was 2.2 mg/L. The concentration after 24 hours was 1.1 mg/L and after 96 hours a concentration of 1.7 mg/L was measured. Hence, the concentration remained fairly stable during the test period despite the extremely low water solubility. The expected LC50 was above 2 mg/L, being three orders of magnitude above the maximum solubility in water as was determined (< 6 µg/L).
Reference substance (positive control):
yes
Remarks:
Pentachlorophenol (PCP)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 4.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test mat. WAF
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
4.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test mat. WAF
Basis for effect:
mortality
Details on results:
Analytical results range finding test: No mortality or clinical effects were observed at any of the test concentrations during the test period. Based on these results samples taken from the WAF prepared at 100 mg/L were analysed. The initial concentration was 2.2 mg/L. The concentration after 24 hours was 1.1 mg/L and after 96 hours a concentration of 1.7 mg/L was measured. Hence, the concentration remained fairly stable during the test period despite the extremely low water solubility. The expected LC50 was above 2 mg/L, being three orders of magnitude above the maximum solubility in water as was determined (< 6 µg/L).

Analytical results final limit test: Analysis of the samples taken from the WAF prepared at 100 mg/L showed that measured concentrations decreased from 9.9 mg/L at the start to 5.1 mg/L after 24 hours and further to 3.1 mg/L after 96 hours of exposure. The decrease was expected to be related to the extremely low solubility (<6 µg/L in water) and as such it was justified to conclude that testing was performed at or above the limit of solubility. The average exposure concentration was calculated to correspond to 4.8 mg/L.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50 = 0.25 mg/L (95% CL: 0.20 - 0.41 mg/L
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
04 - 09 April 1998
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF) were prepared by stirring the test substance in the dilution water for 24 hours to reach equilibrium
concentration. A 20 L complete glass basin was appointed with a glass tube, by what the aqueous phase could be take off witout contamination of the unsolved film of the hydrocarbon. Before the take off of the aqueous phase the preparation was left for 1 hour for complete phase separation.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: MPI für Entwicklungsbiologie, Tübingen, Germany
- Length at study initiation (length definition, mean, range and SD): 3.1 - 3.5 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: At least 12 d
- Health during acclimation (any mortality observed): Mortality ≤ 5%

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
23 ± 2 °C
pH:
8.2 - 8.4
Dissolved oxygen:
> 91%
Nominal and measured concentrations:
Nominal: 10000 mg/L (WAF)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 10 L/ basin
- Aeration: yes, constant with Pasteur pipettes
- Renewal rate of test solution (frequency): every 24 h
- No. of organisms per concentration: 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: By aeration (1-2 d) dechlorinated tap water
- Intervals of water quality measurement: Oxygen content, pH-value and temperature were registered after 24 h, 48 h, 72 h and 96 h.

OTHER TEST CONDITIONS
- Photoperiod: 14 light, 10 h dark (Gro-Lux)

EFFECT PARAMETERS MEASURED: Schooling behaviour, activity (mobility), surfacing, floatability
(equilibrium behaviour), dead animals, breathing frequency
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: WAF loading rate
Details on results:
- Behavioural abnormalities: 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the school
and showed lower activity. After 72 h the schooling behaviour of the rest of the fish was also disturbed. The activity and the equilibrium behaviour
was equal to the control fish.
- Other biological observations: The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same
behaviour as the control fish.
- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: WAFs showed light turbidity, but
contained no visible emulsion drops.

No mortality of the fish could be observed in the control and the test concentration (10000 mg/l WAF) after 96h under conditions tested. 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the swarm and showed lower activity. But after 72 h the swarm behaviour of the rest of the fish was also disturbed. However, the activity and the equilibrium behaviour was equal to the control fish. The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same behaviour as the control fish. As WAFs showed light turbidity and the water solubility of the test substance is < 0.3 mg/l, the abnormal behaviour could cause in unsolved test substance. Overall no mortality could be observed and therefore the LL50 is > 10000 mg/l. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance were observed and therewith the LC50 (96h) is > water solubility of the test substance.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
Qualifier:
according to
Guideline:
other: OECD series on testing and assessment 23, 2000
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: During the limit test singular samples for possible analysis were taken from the limit concentration and the control at t=0 h, t=24 h, and t=96 h
- Sampling method: 2 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis

Additionally, singular reserve samples of 2 mL were taken from all test solutions for possible analysis. If not already used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of test solutions started with a loading rate of 100 mg/L applying 2 days of magnetic stirring to ensure maximum dissolution in test medium. The resulting dispersion was left to settle for 1 hour (range-finding test) or 2 hours (final limit test) were after the Water Accomodated Fraction (WAF) was collected by siphoning for use as highest test concentration. Note that in the final limit test the WAF was siphoned twice using a tube containing glass wool in the first siphoning step. The lower test concentrations for the range-finding test were prepared by subsequent dilutions in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The final test solutions were clear and colourless in the range-finding test and slightly hazy in the final limit test with a slight floating layer.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Age at study: F1 from a single parent-pair bred in UV-treated water
- Length at study initiation (mean): Range-finding test: 3.3 ± 0.2 cm, Limit test: 3.3 ± 0.1 cm
- Weight at study initiation (mean): Range-finding test: 1.09 ± 0.29 g, Limit test: 0.97 ± 0.06 g
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Type and amount of food: pelleted fish food (Cyprico Crumble Excellent (300-500 µm), Coppens International bv, Helmond, The Netherlands)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
180 mg/L expressed as CaCO3
Test temperature:
21.1 °C - 22.5 °C
pH:
7.3 - 8.0
Dissolved oxygen:
6.4 - 9.1 mg/L
Nominal and measured concentrations:
range finding test: 0.1, 1.0, 10 and 100% of the WAF prepared at a loading rate of 100 mg/L (nominal)
final limit test: control, 100% of the WAF prepared at a loading rate of 100 mg/L (nominal)
final limit test: control, 4.8 mg/L (measured)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: glass vessels, 40-L, 15 L fill volume
- Aeration: no
- No. of organisms per vessel: 3 (range finding test), 7 (final limit test)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.45 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands) with the following composition:
CaCl2.2H2O: 211.5 mg/l
MgSO4.7H2O: 88.8 mg/l
NaHCO: 346.7 mg/l
KCl: 4.2 mg/l
- Intervals of water quality measurement: pH, nitrate, nitrite and ammonia concentration: once a week. Temperature: continuous. In addition, pH and temperature were measured before transferring the fish to the test system

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 16 hours light, 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observation for any dead or severely distressed fish at 2.25, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10 (range-finding test)
- Justification for using less concentrations than requested by guideline: No mortality or clinical effects were observed at any of the test concentrations during the test period
- Range finding study
- Test concentrations: 0.1, 1.0, 10 and 100% of the WAF
- Results used to determine the conditions for the definitive study: No mortality or clinical effects were observed at any of the test concentrations during the test period. Based on these results samples taken from the WAF prepared at 100 mg/L were analysed. The initial concentration was 2.2 mg/L. The concentration after 24 hours was 1.1 mg/L and after 96 hours a concentration of 1.7 mg/L was measured. Hence, the concentration remained fairly stable during the test period despite the extremely low water solubility. The expected LC50 was above 2 mg/L, being three orders of magnitude above the maximum solubility in water as was determined (< 6 µg/L).
Reference substance (positive control):
yes
Remarks:
Pentachlorophenol (PCP)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 4.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test mat. WAF
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
4.8 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: test mat. WAF
Basis for effect:
mortality
Details on results:
Analytical results range finding test: No mortality or clinical effects were observed at any of the test concentrations during the test period. Based on these results samples taken from the WAF prepared at 100 mg/L were analysed. The initial concentration was 2.2 mg/L. The concentration after 24 hours was 1.1 mg/L and after 96 hours a concentration of 1.7 mg/L was measured. Hence, the concentration remained fairly stable during the test period despite the extremely low water solubility. The expected LC50 was above 2 mg/L, being three orders of magnitude above the maximum solubility in water as was determined (< 6 µg/L).

Analytical results final limit test: Analysis of the samples taken from the WAF prepared at 100 mg/L showed that measured concentrations decreased from 9.9 mg/L at the start to 5.1 mg/L after 24 hours and further to 3.1 mg/L after 96 hours of exposure. The decrease was expected to be related to the extremely low solubility (<6 µg/L in water) and as such it was justified to conclude that testing was performed at or above the limit of solubility. The average exposure concentration was calculated to correspond to 4.8 mg/L.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50 = 0.25 mg/L (95% CL: 0.20 - 0.41 mg/L

Description of key information

Conclusions are based on read-across from analogue substances of a known category.
No effects up to the limit of water solubility (OECD 203); read-across

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of Pentaerythritol, mixed esters with linear and branched fatty acids to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances and Fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) was conducted. The source substances are representative to evaluate the short-term toxicity of the target substance to fish. The target substance is characterized as a tetraester of pentaerythritol and linear and branched fatty acids. The source substances are structurally very similar to the target substance. Fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2) is characterized as a tetraester of pentaerythritol with fatty acids of C5-C9. The source substance Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6) is a triester of trimethylolpropane and C8-C10 fatty acids (even numbered).

This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13.

The first study investigated the short-term toxicity of the source substance fatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2) to freshwater fish according to OECD 203 (GLP) under static conditions using Cyprinus carpio as test organism (Migchielsen, 2012). A nominal loading rate of 100 mg/L (prepared as WAF) was applied. Test substance monitoring measured a concentration of 4.8 mg/L. The final test solution was slightly hazy with a floating layer; however, this is considered negligible, because no mortality was observed in the treatment throughout the test period of 96 h. Hence, the LL50 (96 h) is determined to be > 100 mg/L (nominal) and > 4.8 mg/L (measured) and thus above the limit of water solubility (< 0.006 mg/L, purified water).

The second study investigating the short-term toxicity to freshwater fish of Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS-No. 11138-60-6) with Brachydanio rerio (Danio rerio) according to OECD 203 determined LL50 (96 h) > 10000 mg/L (WAF loading rate)(Kuttler, 1998).As WAFs showed light turbidity and the water solubility of the test substance is < 0.3 mg/l, the abnormal behaviour could cause in unsolved test substance. Overall no mortality could be observed and therefore the LL50 is > 10000 mg/l. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance were observed and therewith the LC50 (96h) is > water solubility of the test substance.

Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Pentaerythritol, mixed esters with linear and branched fatty acids will not exhibit short-term effects to fish up to the limit of water solubility.


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