Registration Dossier
Registration Dossier
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EC number: 268-006-8 | CAS number: 67989-22-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 42535, molybdatephosphate salt.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January - March 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates
- EC Number:
- 309-916-8
- EC Name:
- Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates
- Cas Number:
- 101357-19-1
- Molecular formula:
- Reaction mass of C25 H30 N3. P Moy Wz O40 (y +z = 12) , C24 H28 N3. P Moy Wz O40 (y +z = 12) and C23 H26 N3. P Moy Wz O40 (y +z = 12)
- IUPAC Name:
- Reaction mass of [4-[bis[4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates, [4-[[4-(dimethylamino)phenyl]-[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates and [4-[bis[4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]-dimethyl-ammonium. molybdatetungstatephosphates
- Test material form:
- other: Violet paste
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5 cm).
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day.
- Water: tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 -21.7°C
- Humidity (%): 32 - 57%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
CONTROL
Adjacent areas of the untreated skin of each animal served as controls. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2x3 cm
- Type of wrap if used: Micropore tape, secured with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with tab water
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no evidence of a corrosive or irritation effect on the skin.
- Other effects:
- Purple staining of the treated skin by the test substance was observed throughout the study period, which did not hamper the scoring of the skin reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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