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EC number: 271-591-2 | CAS number: 68585-82-0
- 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
Several acute oral studies are available both with yttrium oxide itself as well as with europium oxide itself. As all studies indicated an LD50 >2000 mg/kg no further studies were performed. No acute dermal toxicity is available as the inhalation exposure is more likely due to the small particle size of the substance. An acute inhalation toxicity study with yttrium oxide is available showing an LD50 >5.09 mg/L. These results are read-across to yttrium oxide, europium doped.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The rationale to read across the data is attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- 3 doses (1000, 2500 and 5000 mg/kg bw) were tested. The vehicle was an aqueous dispersion of 10% arabic gum. 2 males and 2 females were used per dose. Mortality checks were performed at 1, 2, 4h, and then on days 1, 2, 4, 7 and 14.
No mortality was observed. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality were observed in rats dosed with 0 or 5000 mg/kg bw yttrium oxide.
- Clinical signs:
- other: No clinical signs were observed in rats dosed with 0 or 5000 mg/kg bw yttrium oxide.
- Gross pathology:
- No gross abnormalities were observed at necropsy.
- Other findings:
- - Organ weights: no data
- Histopathology: no data
- Potential target organs: no data
- Other observations: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute oral toxicity study was performed with yttrium oxide according to OECD guideline 401. As the LD50 in males and females (Oral LD50 Combined (males and females)) exceeded 5000 mg/kg bw,Yttrium oxide is not classified for acute oral toxicity. This result is read across to yttrium oxide, europium-doped.
- Executive summary:
In an acute oral toxicity study performed according to OECD guideline 401, groups of fasted, 6-7 week old Sprague Dawley rats (5/sex) were given a single oral dose of yttrium oxide (> 99.9 % a.i.) in aqueous dispersion of 10% arabic gum at dose of 5000 mg/kg bw (limit test). The rats were observed for 14 days. No clinical signs and no mortality were observed during the study. Therefore, the oral LD50 combined (males and females) of yttrium oxide is > 5000 mg/kg bw. This result is read across to yttrium oxide, europium-doped.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- One key study is available (performed on a substance analogue) and several studies supporting the result of the selected key study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The rationale to read across the data is attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.09 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortallity observed
- Clinical signs:
- other: Following exposure, all animals exhibited irregular respiration. However, all animals recovered from this symptom by Day 2 and appeared active and healthy for the remainder of the 14-day observation period.
- Body weight:
- Although all animals lost body weight by Day 1, all animals showed a continued weight gain thereafter through Day 14.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute inhalation study was performed with yttrium oxide according to OECD guideline 436 and GLP principles. Under the conditions of this study, the single exposure acute inhalation LC50 of the test substance is greater than 5.09 mg/L (limit test, OECD) in male and female rats. In accordance with the provisions of Regulation (EC) No. 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures, classification is not required based on the results of this study. This result is read across to yttrium oxide, europium-doped.
- Executive summary:
In an acute inhalation nose only toxicity study, female and male rats were exposed to 5.13 mg/L (nominal) yttrium oxide as aerosol according to OECD test guideline 436. The gravimetric and nominal chamber concentrations were 5.09 mg/L and 9.31 mg/L, respectively. Based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler, the mass median aerodynamic diameter was estimated to be 2.97 μm. The total amount of test substance used was 81.0 grams.
All animals survived exposure to the test atmosphere. Following exposure, all animals exhibited irregular respiration. However, all animals recovered from this symptom by Day 2 and appeared active and healthy for the remainder of the 14-day observation period. Although all animals lost body weight by Day 1, all animals showed a continued weight gain thereafter through Day 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Therefore, the LC50 was determined to be >5.09 mg/L. This result is read across to yttrium oxide, europium-doped.
Reference
TABLE 1: PRE-TEST EXPOSURE TRIALS
Trial N° | Compressed/Mixing Air Pressure (psi) | Compressed Air Volume (Lpm) | Compressed Mixing Air (Lpm) | Total Air Volume (Lpm) | Dust Generator Motor Setting | Packing Pressure (lbs/in2) | Chamber Conc. (mg/L) | Particle Size Sampled |
1 | 30/30 | 30.0 | 6.0 | 36.0 | 15.0 | 2,000 | 11.60 | No |
2 | 30/30 | 30.0 | 6.0 | 36.0 | 10.0 | 2,000 | 6.88 | No |
3 | 30/30 | 30.0 | 6.0 | 36.0 | 8.0 | 2,000 | 5.13 | Yes |
TABLE 2: SUMMARY OF PRE-TEST EXPOSURE TRIAL
Trial No. | Chamber Concentration (mg/L) | Mass Median Aerodynamic Diameter2 (μm) |
3 | 5.13 | 2.88 |
TABLE 3: GRAVIMETRIC CHAMBER CONCENTRATIONS
Sample Number Chamber | Time of Sample (hour) | Mass Collected (mg) | Airflow Sampled (Lpm) | Collection Time (min) | Concentration (mg/L) |
1 | 0.5 | 20.4 | 4 | 1 | 5.10 |
2 | 1 | 20.3 | 4 | 1 | 5.08 |
3 | 2 | 21.2 | 4 | 1 | 5.30 |
4 | 2.5 | 20.3 | 4 | 1 | 5.08 |
5 | 3.5 | 19.5 | 4 | 1 | 4.88 |
6 | 3.75 | 20.4 | 4 | 1 | 5.10 |
Average + standrad deviation: 5.09 + 0.13
Table 4: SAMMARY OF PARTICULE SIZE DISTRIBUTION:
Sample No. | Time of Sample (hours) | Collection Time (minutes) | Mass Median Aerodynamic Diameter (μm) | Geometric Standard Deviation |
1 | 1.5 | 1 | 3.07 | 2.17 |
2 | 3 | 1 | 2.86 | 2.14 |
TABLE 5: INDIVIDUAL BODY WEIGHTS
Animal No. | Sex | Body Weight (g) | Body Weight (g) | Body Weight (g) | Body Weight (g) | Body Weight (g) |
Initial | Day 1 | Day 3 | Day 7 | day 14 | ||
3301 | M | 309 | 296 | 304 | 322 | 340 |
3302 | M | 288 | 280 | 285 | 300 | 315 |
3303 | M | 305 | 294 | 300 | 318 | 330 |
3304 | F | 196 | 194 | 195 | 207 | 211 |
3305 | F | 209 | 206 | 209 | 219 | 230 |
3306 | F | 200 | 194 | 199 | 209 | 217 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 090 mg/m³ air
- Quality of whole database:
- Study on substance analogue was performed according to current OECD test guideline and GLP principles.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No study with yttrium oxide, europium doped is available. However, several studies with yttrium oxide and also with europium oxide are present. The justification for this analogue approach is described in a report (see section 13 of IUCLID).
Oral:
In an acute oral toxicity study performed according to OECD test guidelines, groups of fasted, 6-7 week old Sprague Dawley rats (5/sex) were given a single oral dose of yttrium oxide in aqueous dispersion of 10% arabic gum at dose of 5000 mg/kg bw (limit test) and observed for 14 days. No clinical signs and no mortality were observed during the study. The LD50 was determined to be >5000 mg/kg bw.
In supporting acute oral toxicity studies, groups of fasted, Sprague-Dawley rats (5/sex) were given a single oral dose of yttrium oxide or of europium oxide in distilled water at dose of 5000 mg/kg bw and observed for 14 days. The LD50 for both substances is determined to be > 5000 mg/kg bw.
Inhalation:
In an acute inhalation toxicity study performed according to OECD test guideline and GLP principles, rats were exposed to yttrium oxide aerosols at limit concentration. The gravimetric and nominal chamber concentrations were 5.09 mg/L and 9.31 mg/L, respectively. Based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler, the mass median aerodynamic diameter was estimated to be 2.97 μm. All animals survived exposure to the test atmosphere. Following exposure, all animals exhibited irregular respiration. However, all animals recovered from this symptom by Day 2 and appeared active and healthy for the remainder of the 14-day observation period. Although all animals lost body weight by Day 1, all animals showed a continued weight gain thereafter through Day 14. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Therefore, the LC50 was determined to be > 5.09 mg/L.
Dermal:
No acute dermal toxicity study is available as already studies for two routes of exposure are available, and the inhalation exposure is due to its low particle size much more likely compared to the dermal exposure (low absorption potential).
Justification for classification or non-classification
Based on all the availabe data, yttrium oxide, europium doped is not classified for acute toxicity according to CLP Regulation (EC) No. 1272/2008 including its amendments.
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