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EC number: 481-970-6 | 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:
- 29th March 2007 to 1st April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
- Remarks:
- Date of inspection: 30th August 2005 Date of signature: 21st November 2005
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's identification: C-C1
Description : dark blue powder
Batch number : MB-1
Date received : 05 March 2007
Storage conditions: room temperature in the dark over silica gel
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: an accredited supplier
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: ad libitum access to Certified Rabbit Diet
- Water: ad libitum access to mains drinking water
- Acclimation period: acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES: From: 0 To: End of study
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material moistened with 0.5 ml of distilled water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back of rabbit 2.5 cm x 2.5 cm
- % coverage: 100% coverage within area
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water at end of exposure period
- Time after start of exposure: 4 hours
SCORING SYSTEM: Classification according to the Draize scheme.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- : Animal 1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect produced
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- : Animal 2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect produced
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- : Animal 3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect produced
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : Animal 1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect produced
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : Animal 2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect produced
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : Animal 3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect produced
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study.
- Other effects:
- Blue-coloured staining was noted at all treated skin sites during the study. This did not affect evaluation of skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as Non irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Classification according to Regulation (EC) No. 1272/2008 (CLP) is not required. - Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)
§ Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.
Conclusion. The test material produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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