Registration Dossier
Registration Dossier
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EC number: 692-448-4 | CAS number: 170621-28-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 - 21 Feb 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministère de l'Économie, des Finances et de l'Industrie, Secrétariat général du groupe interministériel des produits chimiques, DGCIS, Service de l'industrie, bureau de la chimie, Paris, France
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide
- EC Number:
- 692-448-4
- Cas Number:
- 170621-28-0
- Molecular formula:
- Mg2xAl2xVyOz
- IUPAC Name:
- divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide
- Test material form:
- solid: particulate/powder
- Details on test material:
- light yellow
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, Le Genest Saint Isle, France
- Age at study initiation: 7 weeks (males) and 8 weeks (females)
- Weight at study initiation: 217-246 g (males) and 198-206 g (females)
- Housing: animals were housed individually during treatment and then in groups of 5 during the observation period. Rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contained sawdust bedding.
- Diet: pelleted diet M20 (SDS), ad libitum
- Water: tap-water from the public distribution system, 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
- Type of coverage:
- semiocclusive
- Vehicle:
- other: liquid paraffin
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed by rinsing with liquid paraffin.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 10 mL/kg bw
- Concentration: 0.2 g/mL
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animal was weighed on Day 0 (before test substance administration), 2, 7 and 14. Systemic examinations were carried out daily during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, necropsy included macroscopic examination of animals - Statistics:
- For body weights, mean values and standard deviations were calculated for all animals.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred 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:
- The macroscopic examination revealed no treatment-related changes.
- Other findings:
- - Other observations: a slight yellow coloration was noted on the treatment site 24 and 48 h after test substance application in all males (5/5).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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