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Diss Factsheets
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EC number: 940-202-4 | CAS number: 1175612-76-6
- 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
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:
- 27 May and 08 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data is based on GLP compliant data accordingly to internationally recognised and EU guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure period.
- Duration of treatment / exposure:
- One patch was removed at each of three time points: 3 minutes, 1hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Observation period:
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later
- Number of animals:
- 3
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to skin
- Executive summary:
The primary irritation has been assessed by application of the neat substance to the intact clipped skin of New Zealand white rabbits according to the OECD 404 test method. The substances cause no significant or un reversible skin reactions and is classified as non-irritant.
Reference
Individual Skin Reactions Following 4-Hour Exposure
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19-22 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data is based on GLP compliant data accordingly to internationally recognised and EU guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to eyes
- Executive summary:
The primary eye irritation of the neat substance has been assessed in the eyes of New Zealand white rabbits according to the OECD 405 test guideline. The substance initially caused cunjunctival redness of score 1 in two animals at 1 hour. No effects were observed at 24 hours or at any remaining observation point.
Reference
The eyes were examined at 1, 24, 48 and 72 hours after the application.
Initial Pain Reaction (IPR) (score 1) was observed in two animals.
One hour after the application, conjunctival redness (score 1) was observed in two animals.
At 24 hours after treatment, fully recovery was noted.
At 48 hours after treatment, there were no clinical signs observed.
At 72 hours after treatment, there were no clinical signs observed.
As there were no clinical signs observed, the study was terminated after the 72 hour observation.
During the study, the control eye of all animals was symptom-free. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
chemosis : 0.00, 0.00, 0.00
discharge : 0.00, 0.00, 0.00
redness : 0.00, 0.00, 0.00
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A single study (Sanders) is available for the assessment. The data is of K1 quality and adequate for hazard assessment and classification of the substance.
Justification for selection of eye irritation endpoint:
A single study (Tavaszi) is available for the assessment. The data is of K1 quality and adequate for hazard assessment and classification of the substance.
Justification for classification or non-classification
A single study (Sanders for skin irritation and Tavaszi for eye irritation) is available for each assessment. The data are of K1 quality and adequate for hazard assessment and classification of the substance.
No adverse reactions were noted in either study to skin or eye beyond the initial 1 hour observation. The substance is therefore Not Classified for irritation (or corrosivity) to skin or eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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