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EC number: 942-643-8 | CAS number: -
- 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
The substance lutetium aluminium oxide, cerium doped, garnet (variation L174) was tested for acute oral toxicity and for acute dermal toxicity.
The substance did not show any acute toxicity or other treatment-related adverse effects in both routes.
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:
- 2009-04-21 to 2009-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: animals 1 - 3: 177 - 198 g; animals 4 - 6: 180 - 220 g
- Fasting period before study: 16 - 19 h. Access to water was permitted.
- Housing: Semi-barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: all animals 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: all animals: 2009-04-21 To: animals 1 - 3: 2009-05-12; animals 4 - 6: 2009-05-14
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g /mL
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: non-toxic characteristics
- Lot/batch no. (if required): B. Braun Melsungen, lot no. 7494A191
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
DOSAGE PREPARATION (if unusual): Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before every dose administration.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No severe toxicity expected. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days)
- Frequency of observations and weighing: day 0 (pre-dose, 30 minutes and 4 h post dose), day 7, day 14 as a minimum
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut off
- Mortality:
- No mortality observed
- Clinical signs:
- other: Prior to the administration a detailed clinical observation was made of all animals. A careful clinical observation was made several times on the day of dosing; at least once during the first 30 minutes and with special attention during the first 4 hours
- Gross pathology:
- No special gross pathological changes were recorded for any animal.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 cut off (rat) of L174 via the oral route was 5000 mg/kg body weight.
- Executive summary:
The oral toxicity of L174 was examined in a GLP guideline study according to OECD 423.
Under the conditions of the study, a single oral application to rats at a dose of 2000 mg/kg body weight was neither associated with signs of toxicity nor mortality.
The median lethal dose of L174 after single oral administration to female rats, observed over a period of 14 days is:
LD50 cut off (rat): 5000 mg/kg body weight.
The substance does not require classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- K1
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-04-07 to 2009-05-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation (administration): males 342 - 392 g, females 215 - 232 g
- Housing: Semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2009-04-07 To: 2009-05-12 - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area
- % coverage: 10
- Type of wrap if used: Gauze dressing and non-irrittating tape, fixed with an additional dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: moisted with water "aqua ad injectionem"
VEHICLE
- Lot/batch no. (if required): B. Braun Melsungen, lot. no. 7494A191
- Purity: aqua ad injectionem - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on day 0, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: No findings.
- Gross pathology:
- No special gross pathological changes.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After an application period of 24 hours followed by an observation period of 14 days, no mortality and other adverse effects were observed. L174 is non-toxic via the dermal route according to CLP
- Executive summary:
The acute dermal toxicity of L174 was assessed in a GLP limit test according to OECD 402. 2000 mg/kg of the test item were applied on the skin of Wistar rats (5 females, 5 males). The exposure period was 24 h followed by an observation period of 14 days.
No mortalities and no other treatment related other adverse effects were observed.
The substance is considered non-toxic via the dermal route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K1
LD50 > 2000 mg/kg bw
Additional information
The substance lutetium aluminium oxide, cerium doped, garnet (variation L174) was tested for acute oral toxicity and for acute dermal toxicity. The substance did not exhibit any acute toxicity or other treatment-related adverse effects in both routes of exposure. The same toxicological profile is expected for other variations than L174 of the substance lutetium aluminium oxide, cerium doped, garnet.
Justification for selection of acute toxicity – oral endpoint
Available GLP guideline study
Justification for selection of acute toxicity – dermal endpoint
Available GLP guideline study
Justification for classification or non-classification
Lutetium aluminium oxide, cerium doped, garnet did not reveal any toxicity via the oral or dermal route. C&L is not required.
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