Registration Dossier
Registration Dossier
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EC number: 800-777-3 | CAS number: 1351378-24-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Jun - 06 Jul 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on systemic effects are given in the test report
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no information on systemic effects are given in the test report
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES
Test material
- Reference substance name:
- dioxomolybdenum; oxonickel; trioxotungsten
- EC Number:
- 800-777-3
- Cas Number:
- 1351378-24-9
- Molecular formula:
- (Ni)z(Mo)x(W)yO(13 – 20)x
- IUPAC Name:
- dioxomolybdenum; oxonickel; trioxotungsten
- Test material form:
- other: grained solid
- Details on test material:
- - Name of test material (as cited in study report): 2-Butenedioic acid (2Z)-, reaction products with ammonium di-µ3-hydroxyhexacosa-µ-oxododecaoxododecatungstate(6-) (6:1), ammonium octa-µ-oxodi-µ3-oxo-µ4-oxododecaoxoheptamolybdate(6-) (6:1), nickel(2+) nitrate (1:2) and nickel(2+) sulfate (1:1)
- Physical state: green, grained solid
- Analytical purity: > 99%
- Lot/batch No.: 19266-184-1
- Expiration date of the lot/batch: May 2018
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome, Quartier Labaste, Linxe, France
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation: 2.39 - 2.70 kg
- Housing: individual
- Diet: SDS - C15, ad libitum
- Water: tap-water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- (the test item was moistened with distilled water prior to treatment to ensure good contact with the skin)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 1 female (initial test)
2 females (confirmatory test) - Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the flank
- Type of wrap if used: The patch containing the test substance was secured in position with a strip of surgical adhesive tape.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- other: mean out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight erythema were noted on the treated area in 2/3 animals starting 1 h after patch removal which lasted for up to 72 h.
- Other effects:
- Yellow coloration was noted on the treatment site of animal#2 which did not interfere with erythema assessment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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