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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-14 to 2009-05-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Not yet available.
EC Number:
701-019-3
Molecular formula:
(Lu(1-x) Cex)3 Al(5-y) Gay O12, x= 0.005-0.05 and y= 0.1-1.5
IUPAC Name:
Not yet available.
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L173
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: DP/SL 040c/09
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

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: 181 - 197 g; animals 4 - 6: 174 - 177 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: 2009-04-29; animals 4 - 6: 2009-05-12

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 cut off (rat) of L173 via the oral route was 5000 mg/kg body weight.
Executive summary:

The oral toxicity of L173 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 L173 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.