Lutetium aluminium oxide, cerium doped, garnet

Endpoint summary

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

Reference

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.

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

Reference

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.

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.