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EC number: 226-949-2 | CAS number: 5575-43-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- 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:
Referenceopen allclose all
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.
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