Diiron titanium pentaoxide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

For Read-Across Justification please refer to Section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

Positive control with Pentachlorophenol sodium salt performed in addition to blank control.

GLP compliance:

yes

Specific details on test material used for the study:

- Name: Titanium dioxide (bulk)
- Supplier : Sigma-Aldrich
- Lot No. : SZB90960
- Purity : 99.1%
- Appearance : White powder
- Storage condition : Room temperature

Analytical monitoring:

yes

Details on sampling:

- Sampling method: 50 mL of filtered (0.45 μm PTFE membrane filter) and non-filtered samples were transferred into 100 mL beaker in triplicate, respectively

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water Accomodated Fractions according to OECD guideline 23 (OECD, 2000)
- Stirring: 48 hours
- Settling period: 24 hours (suspension and precipitate
- Controls:
Negative control: groundwater without test item.
Positive control: 0.20, 0.30, 0.45, 0.68 and 1.01 mg/L (geometric series 1.5, nominal concentration) Pentachlorophenol sodium salt
- Evidence of undissolved material: No, highest test concentration of 100 mg/L evenly dispersed

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Ricefish (Oryzias latipes)
- Source: Health Care Research Laboratory, KTR (Korea)
- Age at study initiation: 3-4 months old
- Length at study initiation: 2.83 (+/-) 0.16 cm
- Weight at study initiation: 0.19 (+/-) 0.02 g

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not fed 24 hours prior to test
- Health during acclimation: no mortality observed

FEEDING DURING TEST :
- Food type: Tetramin flake (Tetra Co. Germany) in the morning, Blood worm (Hikari sales USA Inc., USA) in the afternoon
- Amount: not specified
- Frequency: two times a day

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

59.2 mg/L as CaCO3

Test temperature:

23.0 °C (Min. 22.9 - Max. 23.1 °C)

pH:

7.48 (Min. 7.33 - Max. 7.94)

Dissolved oxygen:

6.81 mg/L (Min. 5.43 mg/L - Max. 8.09 mg/L)

Salinity:

Not applicable

Conductivity:

Not specified

Nominal and measured concentrations:

Nominal loading rate (mg/L): 0 (control), 100
Measured concentration:
0 h: 0.03 mg/L (non-filtered test solution), <0.02 mg/L (filtered test solution, 0.45 μm PTFE membrane filter)
48 h: 0.04 (non-filtered test solution), <0.02 mg/L (filtered test solution, 0.45 μm PTFE membrane filter)
96 h: 0.03 mg/L (non-filtered test solution), <0.02 mg/L (filtered test solution, 0.45 μm PTFE membrane filter)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass, cylindric glass bath, nominal volume: 12.5 L
- Fill volume: 10 L
- Aeration: not specified
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: not specified

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Groundwater, filtered through 1.0 μm pre-filter and 0.2 μm micro-filter, aerated over 24 hours
- Culture medium different from test medium: no
- Intervals of water quality measurement: every 6 months; no alterating effects to test observed


OTHER TEST CONDITIONS
- Adjustment of pH: not specified
- Photoperiod: 16 hours light and 8 hours dark
- Light intensity: not specified

EFFECT PARAMETERS MEASURED: mortality and abnormal behavior

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study: not reported

Reference substance (positive control):

yes

Remarks:

Pentachlorophenol sodium salt

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities:
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: no (WAF performed)

Results with reference substance (positive control):

Not reported

Sublethal observations / clinical signs:

Table 1. Measured concentration by ICP-OES Analysis (Non-filtered)

Loading rate (mg/L)	Mean measured concentration (mg/L)
	0-hour	48-hour	96-hour
Control	ND	ND	ND
100	0.03(+/-)0.00	0.04(+/-)0.01	0.03(+/-)0.01

*ND : Not detected

Table 2. Measured concentration by ICP-OES Analysis (Filtered)

Loading rate (mg/L)	Mean measured concentration (mg/L)
	0-hour	48-hour	96-hour
Control	ND	ND	ND
100	< 0.02	< 0.02	< 0.02

*ND : Not detected, * 0.02 : Bottom limit of quantitation

Table 3. Cumulative mortality ofOryzias latipes

Loading rate (mg/L)	Number of organisms tested	Cumulative number of dead fish
		24-hour	48-hour	72-hour	96-hour
Control	10	0	0	0	0
100	10	0	0	0	0

Table 4. Symptoms of intoxication of the test substance toOryzias latipes

Loading rate (mg/L)	Symptoms of Intoxication
	24-hour	48-hour	72-hour	96-hour
Control	NOR	NOR	NOR	NOR
100	NOR	NOR	NOR	NOR

*NOR : Normal

Validity criteria fulfilled:

not specified

Conclusions:

In a GLP-compliant limit-test according to ECD Guideline 203 with Oryzias latipes (Ricefish) the 96-h LL50 and NOELR of titanium dioxide were determined to be >= 100 mg/L and 100 mg/L (nominal), respectively.

Executive summary:

A 96-hour Fish, Acute Toxicity Test according to OECD Guideline 203 with titanium dioxide was performed under static conditions and in compliance with the GLP principles. Because of the very low water solubility of titanium dioxide the test solutions were prepared by using Water Accommodated Fractions in accordance with OECD Guideline 23 (2000). Ten fish (Oryzias latipes) were exposed to a limit loading rate of 100 mg test substance/L (1 replicate). In addition, a negative control (10 fish in 1 replicate) and a positive control with the reference substance Pentachlorophenol sodium salt were performed. The results of the test are expressed as loading rates: The 48- and 96-hour LL50 was determined to be >= 100 mg/L. The 48- and 96-hour NOELR was found to be 100 mg/L.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

For Read-Across Justification please refer to Section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

other: TL50

Effect conc.:

> 1 000 mg/L

Conc. based on:

other: Salinity 5.0 ppt

Duration:

96 h

Dose descriptor:

other: TL50

Effect conc.:

> 1 000 mg/L

Conc. based on:

other: Salinity 25.3 ppt

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not specified

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Principles of method if other than guideline:

not further specified

GLP compliance:

not specified

Specific details on test material used for the study:

not specified

Analytical monitoring:

not specified

Details on sampling:

not specified

Vehicle:

not specified

Details on test solutions:

not specified

Test organisms (species):

Fundulus heteroclitus

Details on test organisms:

TEST ORGANISM
- Source: wild cought collected with seines from waters with salinities in excess of 17 ppt (New Jersey, included Shark River, Shrewsbury River and Horseshoe Cove at Sandy Hook)
- Weight at study initiation: 2.7 g (range 1.1 -6.0)

ACCLIMATION
- Acclimation period: not specified
- Acclimation conditions: not specified
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not specified
- Health during acclimation: not specified

QUARANTINE
- Duration: not specified
- Health/mortality: not specified

FEEDING DURING TEST
- Food type: not specified
- Amount: not specified
- Frequency: not specified

Test type:

not specified

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not specified

Hardness:

not specified

Test temperature:

20 °C

pH:

not specified

Dissolved oxygen:

not specified

Salinity:

low (3 to 8 ppt) and high (17 to 23 ppt)

Conductivity:

not specified

Nominal and measured concentrations:

nominal: 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: not specified
- Material, size, headspace, fill volume: not specified
- Aeration: not specified
- Renewal rate of test solution: not specified
- No. of organisms per vessel: 3
- No. of vessels per concentration: 3

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: not specified


OTHER TEST CONDITIONS
- Adjustment of pH: not specified
- Photoperiod: not specified
- Light intensity: not specified

EFFECT PARAMETERS MEASURED: not specified

TEST CONCENTRATIONS : not specified

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

other: TL50

Effect conc.:

> 1 000 mg/L

Conc. based on:

other: Salinity 5.0 ppt

Duration:

96 h

Dose descriptor:

other: TL50

Effect conc.:

> 1 000 mg/L

Conc. based on:

other: Salinity 25.3 ppt

Details on results:

not reported

Results with reference substance (positive control):

not specified

Reported statistics and error estimates:

not reported

Validity criteria fulfilled:

not specified

Conclusions:

In an acute in vivo toxicity test with Fundulus heteroclitus (wild caught) the 96-hour TL50 (median tolerance limit) of the test item at low (5.0 ppt ) and high (25.3 ppt) salinity levels was determined to be >1000 mg/L.

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

For Read-Across Justification please refer to Section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Reference 7

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not specified

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

not specified

GLP compliance:

not specified

Specific details on test material used for the study:

- Name: ultrafine TiO2

Analytical monitoring:

not specified

Details on sampling:

not specified

Vehicle:

not specified

Details on test solutions:

not specified

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

not specified

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not specified

Hardness:

not specified

Test temperature:

12.1-12.5 °C

pH:

not specified

Dissolved oxygen:

not specified

Salinity:

not sapplicable

Conductivity:

not specified

Nominal and measured concentrations:

nominal concentrations: 0.1, 1.0, 10, and 100 mg/L

Details on test conditions:

not reported

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Details on results:

After 96 hours no mortality observed, neither in control nor at test item concentrations of 0.1, 1.0, 10, and 100 mg/L.

Results with reference substance (positive control):

not specified

Reported statistics and error estimates:

not reported

Validity criteria fulfilled:

not specified

Conclusions:

In a static Fish, Acute Toxicity Test according to OECD Guideline 203 with Oncorhynchus mykiss the 96 hour LC50 for the test item was determined to be higher than 100 mg/L.

Description of key information

A study on short-term toxicity with diiron titanium pentaoxide does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur (study scientifically not necessary). However, following an analogue approach a 96-hour LC50 of >= 100 mg/L was determined.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Non-submission justification

No study data for the registration substance diiron titanium pentaoxide are available. The substance was assessed in three guideline studies to be sparingly soluble in water (references 4.8-2,  4.8-3 and 4.8-1). In a worst case approach the water solubility of the test item was determined to be 2.715 µg/L at a temperature of 20 °C (please refer to the endpoint summary in IUCLID section 4.8). Furthermore, the maximum of the mono-modal particle size distribution was observed at approximately between 10 µm and 20 µm. The D10, D50 and D90 percentile were determined as L10 = 7.07 µm, L50 = 13.1 µm and L90 = 22.9 µm, respectively. Considering these physico-chemical properties, diiron titanium dioxide is unlikely to cross biological membranes (please also refer to IUCLID section 7.1). Therefore, in accordance with the criteria given in column 2 of Annex VIII to Regulation (EC) No 1907/2006 (REACH), the study on short-term toxicity to fish is considered scientifically not necessary and was waived.

Nevertheless, information available for the read across source substances titanium dioxide (CAS 13463-67-7) and diiron trioxide (CAS 1309-37-1) is summarized below.

Titanium dioxide

Data from two guideline studies and one non-guideline study with the source substance titanium dioxide (bulk form) is publicly available and is discussed in a Weight of Evidence approach..

One reliable guideline study (Klimisch 1, reliable without restriction) is publicly available for the read across substance titanium dioxide in its bulk form (reference 6.1.1 -1). A 96-hour Fish, Acute Toxicity Test according to OECD Guideline 203 was performed under static conditions and in compliance with the GLP principles. Because of the very low water solubility of the test substance the test solutions were prepared by using Water Accommodated Fractions in accordance with OECD Guideline 23 (2000). Ten fish (Oryzias latipes) were exposed to a limit loading rate of 100 mg test substance/L (1 replicate). In addition, a negative control (10 fish in 1 replicate) and a positive control with the reference substance Pentachlorophenol sodium salt were performed. The results of the test are expressed as loading rates: the 48- and 96-hour LL50 was determined to be >= 100 mg/L. The 48- and 96-hour NOELR was found to be 100 mg/L.

In an acute in vivo toxicity test with Fundulus heteroclitus (wild caught) the 96-hour TL50 (median tolerance limit) of the test item at low (5.0 ppt ) and high (25.3 ppt) salinity levels was determined to be >1000 mg/L (reference 6.1.1 -2).The reliability of the study was classified to be not assignable (Klimisch 4) because its documentation is not sufficient for assessment.

In a static Fish, Acute Toxicity Test according to OECD Guideline 203 with Oncorhynchus mykiss the 96 hour LC50 for the test item was determined to be higher than 100 mg/L (reference 6.1.1 -3). The reliability of the study was classified to be not assignable (Klimisch 4) because its documentation is not sufficient for assessment.

Key information on short-term toxicity to fish provided in public ECHA REACH dossiers for the read across substances titanium dioxide and diiron trioxide

Titanium dioxide

According to the public ECHA REACH dossier for titanium dioxide (last accessed on: 18 March 2020) dispersions of microsized titanium dioxide are not acutely toxic to fish as the LC50 determined in experimental studies was found to be at least higher than 1000 mg/L and up to > 10,000 mg/L in fresh- and saltwater, respectively. Taking into account that microsized titanium dioxide is sparingly soluble in water, the substance is considered to be not acutely toxic to fish up to its solubility limit.

Diiron trioxide

Referring to the public ECHA REACH dossier for diiron trioxide (last accessed on: 18 March 2020) no short-term toxicity to fish was observed up to a concentration of 50000 mg/l (96-h LC0 ≥ 50000 mg/l).

Conclusion

The study does not need to be conducted as the substance is highly insoluble in water and unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur. This conclusion is supported by assessments for the structural analogues diiron trioxide (CAS 1309-37-1) and titanium dioxide (CAS 13463-67-7) demonstrating that short-term toxicity to fish is not to be expected. Both source substances are neither classified for short-term (acute) nor for long-term (chronic) aquatic toxicity according to Regulation (EC) No 1272/2008 (CLP).

Target and source substances are metal-containing inorganic oxides. The target substance diiron titanium pentaoxide is a mixed oxide of titanium dioxide and diiron trioxide. The source substances share the common atoms Ti, O and Fe with the target substance and have very similar physico-chemical properties. Therefore, diiron titanium pentaoxide is also not considered acutely toxic to fish. Additional data on short-term toxicity of diiron titanium pentaoxide to fish are thus scientifically not necessary. Following a weight of evidence approach and based on the most reliable information for the source substance TiO2 (reference 6 .1.1-1) the 96-hour LC50 for diiron titanium pentaoxide is determined to be >= 100 mg/L.