Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-888-6 | CAS number: 110621-40-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 016
- 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
- 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)
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.