Registration Dossier
Registration Dossier
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EC number: 692-448-4 | CAS number: 170621-28-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 - 15 Feb 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministère du redressement productif, Secrètariat general du GIPC DGCIS SI, Ivry-sur-Seine, France
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:
- rabbit
- Strain:
- other: albino New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Linxe, France
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.64-2.88 kg
- Housing: animals were housed individually in boxes.
- Diet: food (SAFE – 112), ad libitum
- Water: drinking water from the public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on one flank of each animal
- Type of wrap if used: the patch was held in place with a strip of surgical adhesive tape under semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was rinsed with distilled water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: 1 h reading time point: very slight erythema in 1 animal
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: 1 h reading time point: very slight edema in 1 animal
- Irritant / corrosive response data:
- One hour after patch removal, a very slight erythema associated with a very slight edema was noted on the treated area of one animal, which was fully reversible at the 24 h reading time point.
- Other effects:
- No further local or systemic effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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