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EC number: 829-719-5 | CAS number: 1190865-44-1
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation / corrosion:
In vivo skin irritation, key study:
The study was performed to assess the irritancy potential of the test item following a single, 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.
The test item was classified as corrosive to rabbit skin (based on one animal).
Eye irritation:
The study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2014-04-09 to 2014-05-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch No.: CPFOA1301
Purity: 98.5% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.74 kg
- Housing: individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 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): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Immediately following patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: the trunk of the rabbit was wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing: any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours after application
OBSERVATION TIME POINTS
Immediately following removal of the patches
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score: 4, immediately following patch removal
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score 3, immediately following patch removal
- Irritant / corrosive response data:
- Grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema were noted in the treated skin site immediately after patch removal. The reactions were indicative of dermal corrosion.
The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction, therefore, the animal was humanely killed immediately after the observation. - Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test item was classified as corrosive to rabbit skin (based on one animal).
- Executive summary:
The study was performed to assess the irritancy potential of the test item following a single, 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.
A single 4-Hour, semi occluded application of the test item to the intact skin of one rabbit produced grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema. The reactions were indicative of dermal corrosion.
The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction, therefore, the animal was humanely killed immediately after the observation.
The test item was classified as corrosive to rabbit skin (based on one animal).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation / corrosion:
In vivo skin irritation, key study, OECD 404:
A single 4-Hour, semi occluded application of the test item to the intact skin of one rabbit produced grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema. The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction.
According to Regulation (EC) No 1272/2008, table 3.2.1, this substance should be classified as Skin corrosion category 1.
Eye irritation:
As the substance is classified as skin corrosion, according to Regulation (EC) No 1272/2008, section 3.3.2.2.2., this substance should be classified as serious eye damage (Category 1).
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