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EC number: 444-340-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP (1997) regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- MV31 K-Salz
- IUPAC Name:
- MV31 K-Salz
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): MV31 K-Salz
- Substance type: Mono-constituent
- Physical state: Solid (Grey granules)
- Analytical purity: 88%
- Purity test date: 19 September 2000
- Lot/batch No.: Lot no. 1268147/1-1268154/1
- Expiration date of the lot/batch:31 December 2001
- Stability under test conditions: Guranteed for 4 hours
- Storage condition of test material: Darkness at approximately 20 C in a fume cupboard
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 GmbH, 88353 Kissleg
- Age at study initiation: No data
- Weight at study initiation: 2.1-3.7 kg
- Housing: Individually in a fully air-conditioned room
- Diet (e.g. ad libitum): Ssniff K-H (V2333), ad libitum and hay (approx. 15g daily)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 C
- Humidity (%): 30-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23 January 2001 To: 09 February 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): 0.5 g of the test article was pasted with 0.15 mL deionized water prior to application
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL of deionized water was used to create a paste of the test article - Duration of treatment / exposure:
- 3 minutes, 1 hour, and 4 hours
- Observation period:
- Observations for skin irritation were recorded at 30-60 minutes and 24, 48 and 72 hours after unwrapping.
- Number of animals:
- 5
- Details on study design:
- TEST SITE
- Area of exposure: 3 minutes: left hind flank, 1 hour: left front flank, 4 hours: right flank
- Type of wrap if used: Semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm tap water
- Time after start of exposure: Immediately following 3 minute, 1 or 4 hour exposure
SCORING SYSTEM: Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- other: Eyrthema scores of 4 were observed in both animals treated for 4 hours.
- Time point:
- other: 30-60 minutes and at 24 hours
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- other: Animals were euthanized at 24 hours post-dose due to the severity of the skin reactions.
- Irritant / corrosive response data:
- No skin reactions were observed in the initial treated animal following 3 minute, 1 hour, and 4 hour exposures. Severe erythema (scores: 4) was observed at 30-60 minutes and 24 hours post-dose in both animals treated for 4 hours. Edema (score: 2) was also boserved in one of those animals at 24 hours post-dose. In addition, necrosis, moderate induration, and pitted skin surface were observed at 24 hours post-dose. In the two additional animals treated for 3 minutes, erythema was observed at 30-60 minutes (scores: 2) and 24 hours (scores: 1) post-dose and cleared by 48 hours post-dose. No edema was observed at any time in these animals treated for 3 minutes.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the study, the test article is corrosive to the skin.
- Executive summary:
The primary dermal irritation/corrosion potential of the test article (grey granules, purity approx. 88 Fl.%, CASRN 496805-64-2, Lot no. 1268147/1-1268154/1) was evaluated in female New Zealand White rabbits. This study was performed in compliance with OECD GLP (1997) and the German Chemical Act (1999). The study method was based on OECD 404 (1992) and Commission Directive 92/69/EEC (1992). The hair was clipped from the dorsal skin of five female rabbits. The test material (0.5 g pasted with 15 mL deionized water) was placed under gauze on three intact test sites of one animal. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape for 3-minute, 1-hour, and 4-hour exposures. Since no skin reactions were observed, two additional animals were similarly treated for a 4-hour exposure. Since corrosive skin reactions were observed in these two animals, two additional animals were similarly treated for a 3-minute exposure. Observations for skin irritation (erythema and edema) were recorded at 30-60 minutes and at 24, 48, and 72 hours after unwrapping. The Primary Irritation Index (PII) could not be calculated since the animals treated for 4 hours were euthanized at 24 hours after unwrapping. No skin reactions were observed in the initial treated animal following 3-minute, 1-hour, and 4-hour exposures. Severe erythema (scores: 4) was observed at 30-60 minutes and 24 hours post-dose in both animals treated for 4 hours. Edema (score: 2) was also observed in one of these animals at 24 hours post-dose. Large areas of skin discoloration were observed at 30-60 minutes and 24 hours post-dose. In addition, necrosis, moderate induration, and pitted skin surface were observed at 24 hours post-dose. These animals were euthanized at 24 hours post-dose due to the severity of the skin reactions. In the two additional animals treated for 3 minutes, erythema was observed at 30-60 minutes (scores: 2) and 24 hours (scores: 1) post-dose and cleared by 48 hours post-dose. No edema was observed at any time in these animals treated for 3 minutes. Based on the results of this study, the test article is corrosive to the skin.
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