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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
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

Constituent 1
Chemical structure
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

(1st) 2000

0

/

0

/

3

 

--

 

 

--

 

0

(2nd) 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.