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EC number: 234-679-1 | CAS number: 12023-27-7
- 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
Endpoint summary
Administrative data
Description of key information
No adverse effects are observed in an oral toxicity study according to OECD TG 401 with the test substance in rats at the limit dose of 5000 mg/kg bw (reference 7.2.1 -1).
Effects have been observed in an acute inhalation toxicity study according to OECD TG 403 using the pigment, which contains 11% of the target substance. However, the effects observed are only due to the massive overload effects (at 14600 mg/m3). No effects are expected at the limit dose recommended by the current OECD guideline (i.e. 2000 mg/m3). The test material is considered not toxic after acute inhalation (reference 7.2.2-1).
No study is available for the acute dermal toxicity. However, due to 1) the composition of this mixed metal oxide (oxides of iron and titanium), 2) the very low solubility in water, and 3) the assumed negligible bioavailability after dermal application, the performance of an acute dermal toxicity study in rats is considered not necessary.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 February 1990 - 29 March 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Chbb:THOM
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: mean initial weight 182 (172-196) g
- Fasting period before study: rats did not receive any food from 17 h before up to 4 hours after treatment
- Housing: treated rats were kept separately in Makrolon cages type III
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 26
- Humidity (%): 38 - 45
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous 0.25% hydroxypropyl methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 g ad 100 mL
- Amount of vehicle: 20 mL/kg
- Justification for choice of vehicle: solubility
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
- Doses:
- Control: 0 mg/kg bw
Treatment group: 5000 mg/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Behavior and general condition of all rats were monitored for 4-6 hours after administration and then checked daily. All rats were weighted before treatment, as well as on days 2,4,6,8,11,13 and 15 of the study.
- Necropsy of survivors performed: yes - Statistics:
- The bw data were processed by means of the program TOX 511 A.
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during this study.
- Clinical signs:
- other: No clinical findings were observed.
- Gross pathology:
- Gross pathology did not reveal any abnormalities in rats treated the test material.
- Other findings:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the discriminating dose in rats after single oral administration was > 5000 mg/kg body weight.
- Executive summary:
The acute toxicity potential of the test item was evaluated following single oral administration to male and female Wistar rats at a dose level of 5000 mg/kg bw in aqueous 0.25% hydroxypropyl methylcellulose. No deaths were observed during the study. No clinical signs were observed after application up to the end of the 15 -day observation period. Body weight gain of the treated rats was unaffected. Gross pathology did not reveal any abnormalities.
Based on the results of this study, the maximum non-lethal dose of the test material in rats after single oral administration is >5000 mg/kg bw, and Diiron titanium pentaoxide is considered to have no toxic potential after single administration by the oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- OECD TG 401, GLP
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratory Ltd, Füllinsdorf Switzerland
- Age at delivery:
Males: 8 weeks
Females: 10 weeks
- Weight at delivery:
Males: 180 - 200 g
Females: 180 - 200 g
- Fasting period before study:
- Housing: Groups of 5 in Macrolon type-4 cages
- Diet: Pelleted standard Kliba 343 ad libitum
- Water: Community tab water ad libitum
- Acclimation period:12 or 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C +/- 3°C
- Humidity: 30 - 70%
- Air changes: 10 - 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: according to the method of Sachsse. The animals are confined separately in tubes which are positioned radially around the exposure chamber.
- Exposure chamber volume: 1 liter
- Method of holding animals in test chamber: Macrolon animal restraint tubes
- Exposure airflow rate: 1.3 L/min/animal
- System of generating particulates/aerosols: Piston/brush aerosol generator (RBG 1000, Palas GmbH, Karlsruhe, germany)
- Method of particle size determination: Mercer 7-stage cascade impactor
- Treatment of exhaust air: Rebreathing of exhaled air is precluded
- Temperature, humidity: 21°C, 10 - 15% humidity
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric determination of concentration. The test material was collected on glass fiber filters using a stainless steel filter sampling device. The relative aerosol concentration was monitored using a RAM-1 light scattering type aerosol monitor.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- Particle size distribution (in cumulative %):
Group 2 (4.6 mg/L):
> 4.6 µm 3.0 µm 2.13 µm 1.6 µm 1.06 µm 0.715 µm 0.325 µm < 0.325 µm
100 % 81.5 % 71.7 % 57.9 % 40.9 % 26.3 % 15.5 % 6.8 %
Group 3 (14.9 mg/L):
> 4.6 µm 3.0 µm 2.13 µm 1.6 µm 1.06 µm 0.715 µm 0.325 µm < 0.325 µm
100 % 51.4 % 38.8 % 38.2 % 38.0 % 35.9 % 29.1 % 12.8 %
- MMAD (Mass median aerodynamic diameter):
Group 2 (4.6 mg/L): 1.2 µm
Group 3 (14.9 mg/L): 4.6 µm (slightly exceeds the MMAD-range recommended by the guideline) - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric determination
- Duration of exposure:
- 4 h
- Concentrations:
- Group 1 (control): 0 mg/L
Group 2: 4.6 mg/L
Group 3: 14.9 mg/L - No. of animals per sex per dose:
- 5 per sex per group
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality: Once per h during exposure, twice daily until day 15
Body weights: On days 1 (before exposure), 8 and 15
Clinical signs: At least once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 4.6 - < 14.9 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: local effects on overload on the respiratory tract
- Key result
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- > 14.9 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Mortality was observed in 60% of the males exposed to the high conc. (14.9 mg/L).
No mortalities have been observed in the control group and the low conc. group (4.6 mg/L) - Clinical signs:
- other: During exposure, restlessness in all rats (both sexes) exposed to the high concentration (14.9 mg/L) and in a few animals of both sexes of the lower conc. (4.6 mg/L). At the high conc. (14.9 mg/L): labored respiration in surviviing males, hunched posture
- Body weight:
- no effects
- Gross pathology:
- Slightly increased lung weights (not clearly dose-dependent).
In two of the three rats which died sponatneously in the high dose group, the lumen of the trachea was coated with a thick, resistant layer of particles which appeared to be the test material. - Other findings:
- High concentration group:
In the 3 males that died spontaneously, irregular brownish particles were noted in bronchi, bronchioles and alveoli. In addition, one of these rats showed slight alveolar hemorrhage and another showed alveolar edema and acute congestion.
In the 7 rats sacrificed on schedule, a slight to moderate alveolar histiocytosis was noted. Most histiocytes (macrophages) contained mainly brownish birefringent particles. Particles were also noted in the bronchi, bronchioles and alveoli of these rats. Granulomas (slight to marked in extent) containing particles were noted in 6 of these rats. Alveolar hemorrhage was noted in 1 of these rats. Perivascular lymphoid cuffing was noted in 5 rats, and chronic alveolitis in all rats sacrificed on schedule.
Low concentration group:
A slight to moderate alveolar histiocytosis was noted in all rats. Most of these histiocytes contained particles. Slight granulomas were noted in 4 rats. Perivascular lymphoid cuffing and chronic alveolitis were noted in 6 rats in 1 of these rats, slight emphysema was also noted.
Control group:
Minimal to slight perivascular lymphoid cuffing and chronic alveolitis were noted in 4 rats. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The deaths observed in the high concentration group (14.9 mg/L) are assumed to be essential due to local effects of overload on the respiratory tract due to the very high exposure concentration, even in absence of true toxicity of the test material. Deaths may have occured by suffocation produced by overload of inhaled solid particles which exceeded the clearance capacity of the lungs and by partial obstruction of the respiratory airways.
- Executive summary:
An acute inhalation toxicity study has been performed. The study was performed according to OECD guideline No. 403 under GLP regulation. Two groups of rats (5 males + 5 females per group) were exposed via the inhalation route (nose only) to the test material at a low or a high concentration (4.6 or 14.9 mg/L, respectively) during a 4h-period. The test material concentrations of both dose groups exceed the limit dose of 2 mg/L as recommended by the guideline. A control group of 5 males and 5 females were exposed under the same conditions to air only.
The MMADs have been determined as 1.2 µm and 4.6 µm for the low and the high concentration, respectively. The MMAD of the high concentration exceeds the specifications of testing guideline of 1 - 4 µm, which is due to the high concentration. Mortality was observed in animals of the high dose group only: 3 of 5 males died spontaneously shortly after start of exposure. Those deaths are assumed to be essential due to local effects of overload on the respiratory tract due to the very high exposure concentration, even in absence of true toxicity of the test material. Deaths may have occured by suffocation produced by overload of inhaled solid particles which exceeded the clearance capacity of the lungs and by partial obstruction of the respiratory airways. No mortality was observed in the females of the high dose group and in the animals of the lower dose group. Therefore, the overall LC50 (male + female rats) was > 4.6 mg/L. Mean body weights were unremarkable and comparable to those of the respective controls. The test material is considered not toxic and the effects observed can be explained by the very high concentrations tested in the course of this study.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea pigs have been exposed for 1 to 2 hours to iron oxide dust and lung functional parameters were determined: Resistance, compliance, tidal volume, frequency, minute volume.
- GLP compliance:
- no
- Test type:
- traditional method
- Limit test:
- yes
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- >= 0.03 - <= 0.3 µm
- Remark on MMAD/GSD:
- The geometric mean diameter by count of the iron oxide was 0.076 µm with a geometric standard deviation of 2.0.
- Details on inhalation exposure:
- Ferric oxide fume was generated by the combustion of iron pentacarbonyl.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- mass concentration: samples were collected on PTFE filters. For aerosol concentrations above 2 mg/m3 amount of aerosol sampled was determined by weighing. At lower concentrations amount of Fe in sample was determined colorimetrically or by AA.
- Duration of exposure:
- >= 1 - <= 2 h
- Remarks on duration:
- Measurements were made every five minutes during a half-hour control period and every five minutes during a one-hour or in some instances a two-hour exposure period.
- Concentrations:
- 7 mg/m3 (nominal)
- No. of animals per sex per dose:
- 7 to 9 (sex not determined)
- Control animals:
- yes
- Remarks:
- Each animal served as its own control.
- Details on study design:
- Measurement of the mechanical behavior of the lungs of unanesthetized guinea pigs was used as a means of assessing the respiratory response to the substances tested. The rate of flow of gas in the lungs and airway was measured by electrical differentiation of the volume signal with respect to time.
- Dose descriptor:
- LC0
- Effect level:
- > 7 mg/m³ air (nominal)
- Exp. duration:
- 2 h
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Iron oxide aerosol produced no detectable effect on the respiration of the animals.
- Executive summary:
Guinea pigs were exposed head-only for 1 to 2 hours to iron oxide aerosols (7 mg/m3 air nominal) in an plethysmograph and lung functional parameters have been determined. As a result inhalation of iron oxide did not produce any detectable effects. A determination of the LC50 was not possible from this study.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guinea pigs have been exposed to different airborne dusts and freshly generated cigarette smoke. The effect was evaluated by counting the number of lung macrophages and leucocytes using a lavage method 24 h after exposure to TiO2 dusts (0.9 mg/m3).
- GLP compliance:
- no
- Test type:
- traditional method
- Limit test:
- yes
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remark on MMAD/GSD:
- < 3 µm = 90 ± 2%
< 7 µm = 99 ± 0.44% - Details on inhalation exposure:
- The dust aerosol was generated using a RagPe generator which consists of a fan circulating an airstream with the dust through a circular plastic tube.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The concentration of dust in the chambers was determined by sucking air through Millipore membrane filters which were weighted.
- Duration of exposure:
- 8 h
- Concentrations:
- 0.9 mg/m3
- No. of animals per sex per dose:
- 10 (sex not determined) for test item and 45 for control
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 24 hours
- Frequency of observations and weighing: no data on bodyweight or clinical signs have been reported
- Necropsy of survivors performed: no
- Clinical signs including body weight
- Other examinations performed: BAL measurements performed (macrophasges and leucocytes); number of cells in the preparation was counted under a microscope and a differentiation was made between macrophages and leukocytes. Samples of the washout fluid in certain animals were used to prepare a smear for differential counts using a Shandon-Southern Cytospin (SCA-0030). - Statistics:
- Student's t-test
- Dose descriptor:
- LC50
- Remarks on result:
- not determinable
- Remarks:
- number of macrophages slightly increased
- Mortality:
- No mortality was observed.
- Body weight:
- no data
- Gross pathology:
- no data
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Exposure to TiO2 dusts caused a slight increase in the number of lung macrophages in guinea pigs.
- Executive summary:
Guinea pigs have been exposed to different airborne dusts and freshly generated cigarette smoke. The effect was evaluated by counting the number of lung macrophages and leucocytes using a lavage method 24 h after exposure to TiO2 dusts (0.9 mg/m3). TiO2 caused a slight increase in the number of macrophages. No mortality occurred. A determination of the LC50 was not possible from this study.
- Endpoint:
- acute toxicity: inhalation
- 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
- Dose descriptor:
- LC0
- Effect level:
- > 7 mg/m³ air (analytical)
- Exp. duration:
- 2 h
- Endpoint:
- acute toxicity: inhalation
- 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
- Dose descriptor:
- LC50
- Remarks on result:
- not determinable
- Remarks:
- number of macrophages slightly increased
- Endpoint:
- acute toxicity: inhalation
- 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
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 4.6 - < 14.9 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: local effects on overload on the respiratory tract
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 14.9 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 600 mg/m³ air
- Quality of whole database:
- OECD TG 403, GLP
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral
The acute toxicity potential of the test item was evaluated accordimng OECD TG 401 following single oral administration to male and female Wistar rats at a dose level of 5000 mg/kg bw in aqueous 0.25% hydroxypropyl methylcellulose. No deaths were observed during the study. No clinical signs were observed after application up to the end of the 15 -day observation period. Body weight gain of the treated rats was unaffected. Gross pathology did not reveal any abnormalities.
Based on the results of this study, the maximum non-lethal dose of the test material in rats after single oral administration is >5000 mg/kg bw, and Diiron titanium pentaoxide is considered to have no toxic potential after single administration by the oral route.
Acute inhalation
A WoE Approach was used to investigate the acute inhalation toxicity of diiron titanium pentaoxide using data from pigments which contain diiron titanium pentaoxide and data from the oxides titanium dioxide (TiO2) and iron oxide (Fe2O3). There are no data available for diiron titanium pentaoxide.
An acute inhalation toxicity study has been performed with the pigment. The study was performed according to OECD guideline No. 403 under GLP regulation. Two groups of rats (5 males + 5 females per group) were exposed via the inhalation route (nose only) to the test material at a low or a high concentration (4.6 or 14.9 mg/L, respectively) during a 4h-period. The test material concentrations of both dose groups exceed the limit dose of 2 mg/L as recommended by the guideline. A control group of 5 males and 5 females were exposed under the same conditions to air only. The MMADs have been determined as 1.2 µm and 4.6 µm for the low and the high concentration, respectively. The MMAD of the high concentration exceeds the specifications of testing guideline of 1 - 4 µm, which is due to the high concentration. Mortality was observed in animals of the high dose group only: 3 of 5 males died spontaneously shortly after start of exposure. Those deaths are assumed to be essential due to local effects of overload on the respiratory tract due to the very high exposure concentration, even in absence of true toxicity of the test material. Deaths may have occurred by suffocation produced by overload of inhaled solid particles which exceeded the clearance capacity of the lungs and by partial obstruction of the respiratory airways. No mortality was observed in the females of the high dose group and in the animals of the lower dose group. Therefore, the overall LC50 (male + female rats) was > 4.6 mg/L. Mean body weights were unremarkable and comparable to those of the respective controls. The test material is considered not toxic and the effects observed can be explained by the very high concentrations tested in the course of this study.
Furthermore, studies with TiO2 and Fe2O3 are available showing no adverse effects after acute inhalation. However, form these studies no LC50 values could be determined to methodological shortcomings:
Guinea pigs were exposed head-only for 1 to 2 hours to iron oxide aerosols (7 mg/m3 air nominal) in a plethysmograph and lung functional parameters have been determined. As a result inhalation of iron oxide did not produce any detectable effects. In another study Guinea pigs have been exposed to different airborne dusts of TiO2. The effect was evaluated by counting the number of lung macrophages and leucocytes using a lavage method 24 h after exposure to TiO2 dusts (0.9 mg/m3). TiO2 caused a slight increase in the number of macrophages. No mortality occurred.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data for acute oral and inhalation toxicity are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not classified for acute toxicity under Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) 2019/521.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.