Registration Dossier
Registration Dossier
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EC number: 235-101-0 | CAS number: 12068-53-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Sep - 04 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 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
- Test type:
- standard acute 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:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 7 and 8 weeks for male and female rats, respectively
- Weight at study initiation: 229 - 255 g (males), 194 - 229 g (females)
- Housing: individual during treatment, 5 animals per cage thereafter in solid-bottomed clear polycarbonate cages with stainless steel mesh lids
- Diet: M20 (pelleted), Specific Diet Services, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- other: porous gauze dressing
- Vehicle:
- DMSO
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin of the dorsal area of the trunk
- % coverage: 10%
REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed with distilled water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 200 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: as control group, 5 male and female animals received 10 mL/kg bw DMSO by topical administration 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 1, 3 and 5 h after substance administration and daily thereafter and individual body weights were determined periodically on days 0 (prior to substance application), 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, testicles, treatment area, adrenals and pancreas
Results and discussion
Effect levels
- Sex:
- male/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. Erythema were noted on the treated areas of all test animals 24 h after substance application and they were totally reversible on day 2.
- 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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