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EC number: - | 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:
- other: Read across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Data from read across substance. The reliability of the source study is 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- Similar Substance1
- IUPAC Name:
- Similar Substance1
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli s.n.c. - Arona (NO)
- Age on receipt: 2-3 months
- Weight on receipt: 2-3 kg
- Housing:individual cages in T06C air-conditioned room. metal cages meauring 62 x 47.5 x 38 (h) cm with stainless feeder, hung on metal racks.
- Diet: ad libitum GLP 2 RB 15 certificate pelleted diet produced by Charles River Italia's feed licensee Mucedola s.r.l. (Settimo Milanese). The diet was supplemented by the Producer with vitamins and trace elements.
- Water: ad libitumfrom the municipal water main system
- Acclimation period: about 2 months.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2 °C
- Humidity (%): 50±15%
- Air changes (per hr): about 15
- Photoperiod (hrs dark / hrs light): circadian cycle of 12 hrs of light
IN-LIFE DATES: From: June 7, 1994 To: June 21, 1994
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: adjacent areas of untreated skin of each animal served as control for the test.
- Amount / concentration applied:
- 0.5 mL/animal
- Duration of treatment / exposure:
- 3 minutes, 1 and 4 hours
- Observation period:
- immediatley after the 3 minute and the 1 hour-exposure period and at 72 hours and day 8 in the first rabbit and at 1, 24, 48, 72 hours and 8 days after the 4-hour exposure period (all rabbits).
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: trunk
- % coverage: approximately 6cm2 of the skin
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non irritant, hypoallergenic tape.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 3 minutes, 1 hour, 4 hours
SCORING SYSTEM:
The skin reaction was scored according to the following scale:
ERYTHEMA and ESCHAR FORMATION
no erythema: 0
very slight erythema (barely perceptible): 1
well-defined erythema: 2
moderate to severe erythema: 3
severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4
EDEMA FORMATION
no edema: 0
very slight edema (barely perceptible): 1
slight edema (edges of area well defined by definite raising): 2
moderate edema (raised approx 1 mm): 3
severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 94M
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 98M and 100M
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal: 94M, 98M and 100M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15 days
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritant) based on CLP criteria
- Conclusions:
- Skin irritant
- Executive summary:
Experimental data obtained from the dermal irritation study after a single administration of 0.5 mL of the test article PCBTC in the New Zealand White rabbit (3 animals) show that no untoward clinical signs or behavioral alterations were observed. Signs of dermal irritancy were observed in all treated rabbits. The test article PCBTC, when administered by dermal route to rabbits under the experimental conditions adopted, has to be considered IRRITANT for the skin.
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