Registration Dossier
Registration Dossier
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EC number: 235-101-0 | CAS number: 12068-53-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Sep - 05 Oct 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dialuminium zinc tetraoxide
- EC Number:
- 235-101-0
- EC Name:
- Dialuminium zinc tetraoxide
- Cas Number:
- 12068-53-0
- Molecular formula:
- ZnAl2xO(3x+1), x = 1 – 9
- IUPAC Name:
- dialuminum; zinc(2+); oxygen(2-)
- Details on test material:
- - Name of test material (as cited in study report): D-PrisM
- Physical state: white powder
- Analytical purity: 100%
- Composition of test material: zinc aluminate
- Lot/batch No.: PC080519/1
- Expiration date of the lot/batch: 01.06.2018
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley (SPF Caw)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 178 - 208 g
- Fasting period before study: animals were fasted one day prior to substance administration until 4 hrs after substance administration (diet only).
- Housing: 3 animals per cage in solid-bottomed clear polycarbonate cages with stainless steel mesh lids
- Diet: M20 (pelleted), Specific Diet Services, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 (controls), 6 (test substance group; 3 animals per step in a two-step testing procedure)
- Control animals:
- other: as control group, 3 animals received 10 mL/kg bw DMSO via gavage in an additional study performed from 28 Jun - 12 Jul 2011.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 0.5, 1, 3 and 4 h after substance administration and daily thereafter and individual body weights were determined periodically on day 0 (prior to substance administration), 2, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: macroscopical examination of oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals and pancreas
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Macroscopical examinations revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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