Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 435-070-5 | 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
Endpoint summary
Administrative data
Description of key information
No irritation noted.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data originally submitted as part of the 67/548/EEC notification package.
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.4
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
- Irritation / corrosion parameter:
- other: erythema score
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: animal #1 (mean score 1). Time point: overall at 24, 48 and 72 h. (migrated information)
- Irritation / corrosion parameter:
- other: erythema score
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: animal #2 (mean score 2). Time point: overall at 24, 48 and 72 h. (migrated information)
- Irritation / corrosion parameter:
- other: erythema score
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: animal #3 (mean score 3). Time point: overall at 24, 48 and 72 h. (migrated information)
- Irritation / corrosion parameter:
- other: erythema score
- Remarks on result:
- other:
- Remarks:
- Max. score: 0.0. Remarks: Max. duration: d; Max. value at end of observation period: 0 (related to all animals). (migrated information)
- Irritation / corrosion parameter:
- other: edema score
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: animal #1 (mean score 1). Time point: overall at 24, 48 and 72 h. (migrated information)
- Irritation / corrosion parameter:
- other: edema score
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: animal #2 (mean score 2). Time point: overall at 24, 48 and 72 h. (migrated information)
- Irritation / corrosion parameter:
- other: edema score
- Value:
- 0
- Remarks on result:
- other:
- Remarks:
- Basis: animal #3 (mean score 3). Time point: overall at 24, 48 and 72 h. (migrated information)
- Irritation / corrosion parameter:
- other: edema score
- Remarks on result:
- other:
- Remarks:
- Max. score: 0.0. Remarks: Max. duration: d; Max. value at end of observation period: 0 (related to all animals). (migrated information)
- Interpretation of results:
- not classified
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation.
No effects were noted. The substance is not classified. - Executive summary:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation.
No effects were noted. The substance is not classified.
Reference
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data originally submitted as part of the 67/548/EEC notification package.
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.5
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 3
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Irritation parameter:
- chemosis score
- Max. score:
- 3
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.7
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- cornea opacity score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- iris score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 14 days
- Other effects:
- A single application of the test substance to the non- irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation and the remaining treated eye appeared normal at the 14-day observation.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single application of the test substance to the non-irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation and the remaining treated eye appeared normal at the 14-day observation.
- Executive summary:
A single application of the test substance to the non-irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation
and the remaining treated eye appeared normal at the 14-day observation.
The substance is not classified.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites of the animals were examined for evidence of primary irritation. No effects were noted. The substance is not classified.
Eye irritation. A single application of the test substance to the non-irritated eye produced scattered or diffuse to translucent corneal opacity, iridial inflammation and minimal to severe conjunctival irritation. Petechial haemorrhage of the nictitating membrane was noted in one treated eye. One treated eye appeared normal at the 48 hour observation, one other treated eye appeared normal at the 7-day observation and the remaining treated eye appeared normal at the 14-day observation.
Justification for selection of skin irritation / corrosion endpoint:
GLP study
Justification for selection of eye irritation endpoint:
GLP study
Justification for classification or non-classification
No effects noted in in vivo studies.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.