Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (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:

dioxo-2,4-dioxa-1,5-dialumina-3-magnesapentane oxomagnesium alumane

EC Number:

701-289-2

Molecular formula:

Al, MgO, Mg(AlO2)2

IUPAC Name:

dioxo-2,4-dioxa-1,5-dialumina-3-magnesapentane oxomagnesium alumane

Details on test material:

- Name of test material (as cited in study report): Aluminium-Skimmings
- Physical state: grey solid
- Analytical purity: Aluminium: 708.0 g/kg
Ammonium(NH4): 22.0 g/kg
Magnesium: 68.0 g/kg
- Lot/batch No.: Lieferung vom 21.04.2009
- Stability under test conditions: until August 21, 2011
- 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: Harlan GmbH, 5960 AD Horst, The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 165 - 187 g
- Fasting period before study: yes
- Housing: group caged conventionally in polycarbonate cages on low dust wood granulate bedding
- Diet (e.g. ad libitum): standard diet “Provimi Kliba 3883 PM S15 Maus/Ratte Haltung, Kaiseraugst Switzerland”
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2°C
- Humidity (%): 55 ±5%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2010-06-09 To: 2010-06-30

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5 and 200 mg/mL
- Justification for choice of vehicle: preferred non-aqueous vehicle

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000 mg/kg bw was chosen based on the suspected lack of toxicity

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 + 3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily for an observation period of at least 14 days. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 value was estimated according to OECD - Guideline for Testing of Chemicals No. 423 -"Acute Oral Toxicity - Acute Toxic Class Method"; adopted: December 17, 2001.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off value according to OECD 423

Mortality:

no mortality

Clinical signs:

other: no clinical signs

Gross pathology:

no effects

Any other information on results incl. tables

dose mg/kg bw	toxicological result*						occurrence of signs			time of death				mortality (%)
female
(1^st) 2000	0	/	0	/	3			--				--			0
(2^nd) 2000	0	/	0	/	3			--				--			0
*    number of animals which died spontaneously and/or were sacrificed in moribund state / number of animals with signs of toxicity / total number of animals used per group

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No classification for acute oral toxicity.