Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

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

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)

EC Number:

807-888-6

Cas Number:

110621-40-4

Molecular formula:

Al10.33Mg0.67Na1.67O17

IUPAC Name:

Aluminum magnesium sodium oxide (Al10.33Mg0.67Na1.67O17)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 10978-52 H_K
- Expiration date of the lot/batch: March 03, 2018
- Purity: 90.8%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: given
- Solubility and stability of the test substance in the solvent/vehicle: given

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 10 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: in fully air-conditioned rooms
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: September 12, 2016-October 19, 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 3 g/100 mL (300 mg/kg group); 20 g/100 mL (2000 mg/kg groups)
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: 0.5% solution of CMC in deionized water to ensure a homogeneous mixture of the test item

MAXIMUM DOSE VOLUME APPLIED: 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg because no information on the toxicity of the substance was available

SELECTION OF DOSES/CONCENTRATIONS: A starting dose of 300 mg/kg bw was chosen in the first step with 3 female animals.
Because no mortality occurred, 2000 mg/kg bw were administered to 3 female rats in the second step. As no animal died, 2000 mg/kg bw were administered to another group of 3 female animals in the third step.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter. A check for any dead or moribund animals was made at least once each workday. Individual body weights were determined shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in the 300 and 2000 mg/kg bw test groups.

Clinical signs:

In the single 300 mg/kg bw test group all animals showed impaired general state and piloerection from hour 2 until hour 3, 4 or 5 after administration.
In the first 2000 mg/kg bw test group no clinical signs were observed during clinical examination.
In two animals of the second 2000 mg/kg bw test group impaired general state and piloerection was seen from hour 4 until hour 5 after administration. The third animal was free of any clinical symptoms.

Body weight:

The body weights of the test groups increased throughout the study period within the normal range.

Gross pathology:

There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.

Any other information on results incl. tables

Mortality
Dose (mg/kg bw):	300
Sex:	female
Administration:	1
No. of animals:	3
Mortality (animals):	No mortality

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	female	female
Administration:	1	2
No. of animals:	3	3
Mortality (animals):	No mortality	No mortality

Maximum incidence of systemic clinical signs
Dose (mg/kg bw):	300
Sex:	female
Administration:	1
No. of animals:	3
Animal No.:	R 197	R 198	R 199
Abnormalities:
Impaired general state:	h2 - h3	h2 - h5	h2 - h4
Piloerection:	h2 - h3	h2 - h5	h2 - h4

Maximum incidence of systemic clinical signs
Dose (mg/kg bw):	2000
Sex:	female
Administration:	1
No. of animals:	3
Animal No.:	R 213	R 214	R 215
Abnormalities:	-	-	-

Maximum incidence of systemic clinical signs
Dose (mg/kg bw):	2000
Sex:	female
Administration:	2
No. of animals:	3
Animal No.:	R 219	R 220	R 221
Abnormalities:
Impaired general state:	-	h4 - h5	h4 - h5
Piloerection:	-	h4 - h5	h4 - h5

Individual body weight changes
Dose (mg/kg bw):	300
Administration:	1
Animal No.:	R	R	R	Mean weight	Standard- deviation
	197	198	199
Body weight at study day (g):
0	179	177	170	175.3	4.73
7	194	200	194	196.0	3.46
14	207	208	200	205.0	4.36

Individual body weight changes
Dose (mg/kg bw):	2000					2000
Administration:	1					2
Animal No.:	R	R	R	Mean weight	Standard- deviation	R	R	R	Mean weight	Standard- deviation
	213	214	215			219	220	221
Body weight at study day (g):
0	187	188	174	183.0	7.81	177	176	183	178.7	3.79
7	207	211	190	202.7	11.15	183	198	201	194.0	9.64
14	215	226	195	212.0	15.72	190	206	210	202.0	10.58

Gross Pathology
Dose (mg/kg bw):	300
Administration:	1
No. of animals:	3
Animal No.:	R 197	R 198	R 199
Macroscopic pathologic abnormalities :	-	-	-

Gross Pathology
Dose (mg/kg bw):	2000			2000
Administration:	1			2
No. of animals:	3			3
Animal No.:	R 213	R 214	R 215	R 219	R 220	R 221
Macroscopic pathologic abnormalities :	-	-	-	-	-	-

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose of ß''-Alumina (BASF) after oral administration was found to be greater than 2000 mg/kg bw in rats.