Pentaaluminium triyttrium dodecaoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-12-02 to 2011-01-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Test material information

Constituent 1

Reference substance name:

Pentaaluminium triyttrium dodecaoxide

EC Number:

234-465-8

EC Name:

Pentaaluminium triyttrium dodecaoxide

Cas Number:

12005-21-9

Molecular formula:

Al5O12Y3

IUPAC Name:

pentaaluminium triyttrium dodecaoxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): L181
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: VS 503G/10
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:

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: 9 - 10 weeks
- Weight at study initiation: animals 1 - 3: 158 - 165 g; animals 4 - 6: 176 - 182 g
- Fasting period before study: 16 - 19 h. Access to water was permitted.
- Housing: Full barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals 1 - 3: 12 days; animals 4 - 6: 12 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: animals 1 - 3: 2010-12-02; animals 4 - 6: 2010-12-09 To: animals 1 - 3: 2011-12-28; animals 4 - 6: 2011-01-04

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

cotton seed oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle (if gavage): 5 mL
- Justification for choice of vehicle: non-toxic characteristics
- Lot/batch no. (if required): Sigma, lot no. MKBB7604, expiry date 2011-03-01

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

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: daily observation; weighing on days 1 (prior to the administration), 8 and 15
- 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:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

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 post-dose. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.

Clinical signs were not observed during the whole observation period.

Body weight:

Absolute body weights in g and body weight grain in %

day 1 day 8 day 15 % day 1-15
animal 1 158 172 183 16
animal 2 163 178 191 17
animal 3 165 185 190 15
animal 4 182 193 201 10
animal 5 176 198 203 15
animal 6 177 206 222 25

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific 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 value of L181 via the oral route was > 2000 mg/kg body weight.

Executive summary:

The oral toxicity of L181 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 associated with no signs of toxicity or mortality.

The median dose level of L181 after a single oral administration to female rats, observed over a period of 14 days is:

LD50 cut-off (rat): unclassified