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EC number: 919-979-9 | 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
- Remarks:
- Test performed in 2010 for purpose of medical device
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 27/07/2010 to 03/08/2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-10:2002
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ozonized Tetramers and Pentamers
- IUPAC Name:
- Ozonized Tetramers and Pentamers
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Free Ozonized Acids
- IUPAC Name:
- Free Ozonized Acids
- Reference substance name:
- Ozonized Trimers
- IUPAC Name:
- Ozonized Trimers
- Reference substance name:
- Ozonized Dimers
- IUPAC Name:
- Ozonized Dimers
- Reference substance name:
- Ozonized Triglycerides
- IUPAC Name:
- Ozonized Triglycerides
- Test material form:
- other: oiy gel
Constituent 1
impurity 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Allevamento Bettinardi - Mamo (NO) - ltaly
- Weight at study initiation: 3210-3610 g at the beginning ofthe test
- Housing: Each rabbit was caged in stainless steel cages of cm 48.2x63x37 h equipped with automatic washing cycle. The housing room was lighted with fiuorescent lamps 12 hours for day. Room temperature and humidity were regulated by a conditioning pian! and were monitored daily. Recordings of the housing conditions are being retained in Eurofins Biolab S.r.l. files.
- Diet: The animals were fed with standard pellet complete diet supplied by the authorised breeder Harlan.
- Water: Filtered tap water from locai network was supplied ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature and humidity: Room temperature and humidity
- Photoperiod (hrs dark / hrs light): The housing room was lighted with fiuorescent lamps 12 hours for day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0,5 ml of the test product were applied with a gauze (25 mmx 25 mm) directly to the skin on cranial site of each rabbit and covered with non-occlusive dressing
- Duration of treatment / exposure:
- The patches were removed 4 hours alter the application
- Observation period:
- 60min, 24h, 48h, 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6,25cm2
- Type of wrap if used: no irritant gauze
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
- 60min, 24h, 48h, 72h
SCORING SYSTEM:
- Method of calculation: ISO 10993-10:2002
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal: Cranial (left area) and Caudal (right area): Animal number 317 - Animal number 320 - Animal number 354
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: Craudal (right area): Animal number 317 - Animal number 320 - Animal number 354
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: Cranial (left area): Animal number 317 - Animal number 320 - Animal number 354
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: Caudal (right area): Animal number 317 - Animal number 320 - Animal number 354
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: Cranial (left area): Animal number 317 - Animal number 320 - Animal number 354
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: On the basis of the results, interpreted according to GHS regulation, the test substance is considered SLIGHTLY IRRITANT for skin but, according to CLP regulation 1272/08, the subtance is not classified as skin irritant (score for CLP category 2 is from 2
- Irritation parameter:
- erythema score
- Basis:
- animal: Caudal (right area): Animal number 320 - Animal number 354
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: Caudal (right area): Animal number 317
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: On the basis of the results, interpreted according to GHS regulation, the test substance is considered SLIGHTLY IRRITANT for skin but, according to CLP regulation 1272/08, the subtance is not classified as skin irritant (score for CLP category 2 is from 2
- Irritation parameter:
- erythema score
- Basis:
- animal: Cranial (left area): Animal number 317 - Animal number 320 - Animal number 354
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: On the basis of the results, interpreted according to GHS regulation, the test substance is considered SLIGHTLY IRRITANT for skin but, according to CLP regulation 1272/08, the subtance is not classified as skin irritant (score for CLP category 2 is from 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.21
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: On the basis of the results, interpreted according to ISO 10993-10:2002, the test product must be considered SLIGHTLY IRRITANT for the skin, but not irritant according to CLP 1272/08.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- On the basis of the results, interpreted according to GHS regulation, the test substance is considered SLIGHTLY IRRITANT for skin but, according to CLP regulation 1272/08, the subtance is not classified as skin irritant (score for CLP category 2 is from 2,3 to 4.0)
- Executive summary:
On the test substance a toxicological study was carried out to evaluate the possible locai toxic effects, throughout the following test:
- skin irritation test according to ISO 10993-10:2002
The skinirritation test was carriedout through a semi-occlusive application; the test product was applied on the intact skin of 3 rabbits, in the dorsal region both on the left and on the right side.
Each animal had the right caudal region and left cranial region treated with the test product.
The right cranial region and the left caudal region were treated with a non irritant humidified gauze (25mmx25mm), used as control.
Reactions were evaluated 1 hours following the remaval of the patches and were evaluated againat 24, 48 and 72h after exposure.
-After 60 minutes all treated sites shown a very slight erythema.
-After 24 hours two animals shown a well defined erythema in treated cranial site and a very slight erythema in the caudal sites, one animai shown a well defined erythema in both treated sites.
Symptoms disappear completely in all animals in the caudal sites after 72 hours, in the cranial sites after 7 days.
In control regions no oedema or erythema were observed.
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