Aluminium cerium lutetium oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 05, 2013 - April 02, 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

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:

aluminium cerium lutetium oxide

EC Number:

942-299-9

Cas Number:

1279099-21-6

Molecular formula:

Lu2.8-2.99Ce0.01-0.2Al5O12

IUPAC Name:

aluminium cerium lutetium oxide

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Crl:WI (Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Gennany
- Age at study initiation: 9 weeks
- Weight at study initiation: 156 to 181 g
- Fasting period before study: Diet was withheld from about 17 hours before until up to 4 hours after treatment.
- Housing: separately in type III Makrolon cages
- Diet: ad libitum (Provimi Kliba 3433)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 °C
- Humidity (%): 43 - 61%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous Methocel K4M (aqueous hydroxypropylcellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no.: ZE10012N02; ZDP 04/13 and 05/13

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the chemical properties of the test material mortality was not expected at the highest
starting dose of 2000 mg/kg.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily. Mortality of all rats was monitored for at least 6 hours after administration and then checked
daily. All animals were weighed before treatment ( day 1) and on days 2, 4, 6, 8, 11, 13, and 15 of the
experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Prior to testing, an In Vitra Skin Irritation Test was performed with the test item. In this study, no irritating potential could be detected.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen in rats treated with 2000 mg/kg bw.

Clinical signs:

No clinical signs of toxicity were seen.

Body weight:

The body weight development was inconspicuous throughout the study.

Gross pathology:

The gross pathological examination revealed no organ alterations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, it is concluded that the test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats.

Executive summary:

The test material was tested for acute toxicity in 6 female rats after single oral administration of 2000 mg/kg body weight followed by a 2-week observation period.

The study was started with 2000 mg/kg bw in 3 female rats and continued with further 3 females at 2000 mg/kg bw.

No mortality was seen in the 6 female rats treated with 2000 mg/kg bw of the test item. The body weight development was inconspicuous throughout the study. No clinical signs of toxicity were observed. The gross pathological examination revealed no organ alterations.

The LD50 value of the test item is higher than 2000 mg/kg bw after single oral administration in female rats.