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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1991-01-31 until 1991-03-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study comparable to guideline study, conducted under GLP. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than the particular alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the fate and pathways of the substance. The aquatic toxicity testing is considered scientifically unjustified as the substance degrades immediately releasing alcohol and hydrated insoluble titanium dioxides in water. The testing conducted with analogue substances of the category proves that the aquatic toxicity in daphnia and algae studies is similar to the aquatic toxicity of alcohol released to the test water, and the insoluble hydrated titanium oxides precipitated on the bottom of the test vessels. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the aquatic toxicity of the target substance compared to the toxicity of the pure alcohol. As there is a mechanistic reasoning to the read-across, the read-across from the degradation product (relevant alcohol) is used to evaluate the aquatic toxicity and the fate and pathways of the target substance in the environment.
Justification for type of information:
The substance is hydrolytically unstable. When it comes in contact with water or moisture, a complete hydrolysis will take place with no significant reaction products other than the particular alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the fate and pathways of the substance. The aquatic toxicity testing is considered scientifically unjustified as the substance degrades immediately releasing the particular alcohol and hydrated insoluble titanium dioxides in water.
The testing conducted with analogue substance of the category justifies that the aquatic toxicity in daphnia and algae studies is similar to the aquatic toxicity of the alcohol released to test water as the insoluble hydrated titanium oxide, precipitated on the bottom of the test vessels; lacking bioavailability. The identification of the degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance which might change the aquatic toxicity of the target substance compared to the toxicity of the pure alcohol.
As there is a mechanistic reasoning to the read-across, the read-across from the degradation product (relevant alcohol) is used to evaluate the aquatic toxicity and the fate and pathways of the target substance in the environment.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Cited as Directive 84/449/EEC, C.1 ("Acute toxicity for fish")
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Flow-through. The volume of the aquarium was 35 L. The stock solution was prepared using an emulsifier before it was pumped to the aquarium.
- Eluate: 10L/hour
- Controls: negative control and emulsifier control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): MARLOWET R40
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): vehicle control: 28 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms (species):
Leuciscus idus melanotus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Strain: Leuciscus idus melanotus HECKEL
- Source: Eggers, Hohenwestedt, Germany
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): mean 6cm, SD 2 cm
- Weight at study initiation (mean and range, SD): not reported
- Method of breeding: no data
- Feeding during test: none
- Food type:
- Amount:
- Frequency:


ACCLIMATION
- Acclimation period: min. 14 days
- Acclimation conditions (same as test or not): same as test conditions
- Type and amount of food: Tetramin, 3% of body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): animals were free of symptoms


QUARANTINE (wild caught)
- Duration: 14 days, following a prophylactic treatment with ZEPHIROL 1:50,000 for 1 hour
- Health/mortality: no mortalities; all animals were free of symptoms
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
15 °d; Ca/Mg 4:1
Test temperature:
21 °C +/- 1 °C
pH:
7.8 to 7.9 at beginning of the experiment
Dissolved oxygen:
8.6 - 9.1 mg/l at beginning of the experiment
Nominal and measured concentrations:
Nominal: 0, 5, 7, 10, 14, 20, 28 mg/l
Measured: (means): -, 4, 5, 6, 8, 14, 21 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed (no data)
- Material, size, headspace, fill volume: glass, 35 L
- Aeration: flow-through was aerated
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): 10 L/hour
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: no data


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water, dechlorinated
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/Mg ratio: 4:1
- Conductivity: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: 24 hours


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark
- Light intensity: no data


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality; interval 24 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.41
- Justification for using less concentrations than requested by guideline: n.a.
- Range finding study: no range-finding study reported
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
14 mg/L
Nominal / measured:
meas. (arithm. mean)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
17.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
21 mg/L
Nominal / measured:
meas. (arithm. mean)
Details on results:
- Mortality of control: 0%
- Mortality of emulsifier control: 0%
Sublethal observations / clinical signs:

1) The measured test concentrations were less than 80% of the nominal concentrations (Table 1)

Nominal concentration (mg/L)

Measured concentration

(mg/L, means)

5

4

7

5

10

6

14

8

20

14

28

21

2) Mortalities: all fish died at the highest tested dose of 21 mg/L; no mortalities were seen at lower dose levels. A dose-response curve could not be established.

The emulsifier caused no deaths at 28 mg/L (Table 2)

Test concentration
(measured, mg/L)

Number of fish
(alive/dead)

24 h

48 h

72 h

96 h

0

10/0

10/0

10/0

10/0

4

10/0

10/0

10/0

10/0

5

10/0

10/0

10/0

10/0

6

10/0

10/0

10/0

1/9

8

10/0

10/0

10/0

10/0

14

10/0

10/0

10/0

10/0

21

8/2

0/10

0/10

0/10

(Emulsifier: 28)

10/0

10/0

10/0

10/0

3) The following values were calculated from the measured concentrations:

LC0: 14 mg/L; LC50: 17.1 mg/L; LC100: 21 mg/L.

4) The oxygen concentration was always >60%and the pH-value ranged between 7.3 and 8.2 throughout the test.

Read-across justifications and data matrices are presented in IUCLID section 13.

Validity criteria fulfilled:
yes
Conclusions:
The 96 -h LC50 (mortality) of 2 -ethylhexanol to Leuciscus idus melanotus is 17.1 mg/L conducted according to EEC 84/44 similar to OECD test guideline 203 based on measured concentrations.
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1983-11-29 to 1983-12-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study. Not conducted under GLP, but this has no impact on the reliability. Read-across justification: The substance is hydrolytically unstable. When it comes in contact with water or moisture complete hydrolysis will take place with no significant reaction products other than the particular alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the fate and pathways of the substance. The aquatic toxicity testing is considered scientifically unjustified as the substance degrades immediately releasing alcohol and hydrated insoluble titanium dioxides in water. The testing conducted with analogue substances of the category proves that the aquatic toxicity in daphnia and algae studies is similar to the aquatic toxicity of alcohol released to the test water, and the insoluble hydrated titanium oxides precipitated on the bottom of the test vessels. The identification of degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance, which might change the aquatic toxicity of the target substance compared to the toxicity of the pure alcohol. As there is a mechanistic reasoning to the read-across, the read-across from the degradation product (relevant alcohol) is used to evaluate the aquatic toxicity and the fate and pathways of the target substance in the environment.
Justification for type of information:
The substance is hydrolytically unstable. When it comes in contact with water or moisture, a complete hydrolysis will take place with no significant reaction products other than the particular alcohol and hydrated titanium dioxide. This rapid hydrolysis (hydrolysis half-life < 3 minutes to < 2 hours) is the driving force for the fate and pathways of the substance. The aquatic toxicity testing is considered scientifically unjustified as the substance degrades immediately releasing the particular alcohol and hydrated insoluble titanium dioxides in water.
The testing conducted with analogue substance of the category justifies that the aquatic toxicity in daphnia and algae studies is similar to the aquatic toxicity of the alcohol released to test water as the insoluble hydrated titanium oxide, precipitated on the bottom of the test vessels; lacking bioavailability. The identification of the degradation products from the hydrolysis study conducted for the target substance verifies that there are no impurities in the alcohol released from the target substance which might change the aquatic toxicity of the target substance compared to the toxicity of the pure alcohol.
As there is a mechanistic reasoning to the read-across, the read-across from the degradation product (relevant alcohol) is used to evaluate the aquatic toxicity and the fate and pathways of the target substance in the environment.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
- Concentrations: nominal 0, 7.1, 10.9, 16.8, 25.9, and 39.9 mg/L
- Sampling method: samples were taken at 0,24, 48,72 and 96 hours in all exposure chambers
- Sample storage conditions before analysis: samples were analysed immidiately or adequately preserved for later analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: preparation of stock solution (260 mg/L)
- Controls: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none
- Evidence of undissolved material (e.g. precipitate, surface film, etc): not reported
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow
- Strain:
- Source: US PA Research Laboratory-Duluth
- Age at study initiation (mean and range, SD): mean 28-34 days
- Length (mean, SD): 21.9 (+/- 2.0) mm
- Weight (mean, SD): 0.163 (+/- 0.0471) g
- Loading (g/L): 1.630
- Feeding during test: no; not fed 24 hr before or during a test


ACCLIMATION
- Acclimation period: n.a.; fish were bred at the testing facility
- Type and amount of food: brine shrimp

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
46.4 (+/- 0.48) mg/L CaCO3
Test temperature:
24.2 (+/- 0.3) °C
pH:
7.62 (+/- 0.11)
Dissolved oxygen:
6.7 (+/- 0.51) m/L
Nominal and measured concentrations:
Nominal: 0, 7.1, 10.9, 16.8, 25.9, 39.9 mg/L
Measured Corrected): <0.97, 6.55, 9.71, 14.3, 23.2, 36.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: mini-diluter, high flow
- Type (delete if not applicable): open / closed: no data
- Material, size, headspace, fill volume: glass, 2.0 L
- Aeration: >60% saturation
- Type of flow-through (e.g. peristaltic or proportional diluter): mini-diluter, high flow
- Renewal rate of test solution (frequency/flow rate): 25 mL/min to each test chamber; 18 additions/day
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: < 5g/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:


OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 16 hours
- Light intensity: 28-48 lumen at teh water surface


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : behavior and mortality at 0, 24, 48, 72 and 96 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.53
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
28.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

1) The measured test concentrations were between 85 to 92.2% of the nominal concentrations (Table 1)

Nominal concentration (mg/L)

Measured concentration

(mg/L, means)

0

<0.97

7.1

6.55

10.9

9.71

16.8

14.3

25.9

23.2

39.9

36.0

2) Mortalities: after 96 hours mortality was complete at 36 mg/L and 1/20 at 23.2 mg/L. The LC50(96 h) of 28.2 mg/L (confidence limits 27.0 -29.5) was calculated based on the corrected measured values.

Test concentration
(measured, mg/L)

Number of dead fish
(alive/dead)

24 h

48 h

72 h

96 h

0

20/0

20/0

20/0

20/0

6.55

20/0

20/0

20/0

20/0

9.71

20/0

20/0

20/0

20/0

14.3

20/0

20/0

20/0

20/0

23.2

20/0

20/0

20/0

19/1

36.0

20/0

20/0

20/0

0/20

Read-across justifications and data matrices are presented in IUCLID section 13.

Validity criteria fulfilled:
yes
Conclusions:
The 96 -h LC50 (mortality) of 2 -ethylhexanol to Pimephales promelas is 28.2 mg/L conducted by using a method similar to OECD test guideline 203 based on measured concentrations.
Executive summary:

.

Endpoint:
short-term toxicity to fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Testing is not scientifically justified as this substance is hydrolytically unstable and the decomposition products have a low potential

for aquatic bioaccumulation and a low potential to cross biological membranes. Acute toxicity (96-h LC50) of the structuraly similair decomposition product 2-ethylhexanol is used as a key value.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
17.1 mg/L

Additional information

When this substance comes in contact with water or moisture, a complete hydrolysis will take place with no significant reaction products other than EHD and hydrated titanium dioxide (half-life < 10 minutes; structurally similair titanate, Brekelmans M.J.C. 2013). The organic decomposition product EHD is readily biodegradable and not persistent based on the log Kow 3.09 - 3.63 @ 20 °C. The CSA indicates that toxicity of this substance is similar than that of 2-ethylhexanol. Key studies (short-term toxicity to daphnia and algae) conducted for the analogue category member (titanium tetra(octanolate), branched and linear, CAS 68526 -83 -0) justify that these organometallic titanates hydrolyse during toxicity testing and the aquatic toxicity is similar to the alcohol released in water. Category and read-across justifications are presented in the annexes of the CSR.

Therefore, and for reasons of animal welfare, a short-term toxicity study on fish is unjustified, and the key value for CSA is obtained from the studies conducted for 2 -ethylhexanol.

According to Scholz 1991, the 96 -h LC50 (mortality) of 2 -ethylhexanol to Leuciscus idus melanotus is 17.1 mg/L conducted according to EEC 84/44 similar to OECD test guideline 203 based on measured concentrations. According to Geiber et al. 1985, The 96 -h LC50 (mortality) of 2 -ethylhexanol to Pimephales promelas is 28.2 mg/L conducted by using a method similar to OECD test guideline 203 based on measured concentrations. Both these studies are considered as reliable for C&L purposes, and the lowest value is selected as a key value for CSA.