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EC number: 413-110-2 | CAS number: 135861-56-2
- 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: not irritating (Annex V; GLP)
Serious eye damage/eye irritation: not irritating (Annex V; GLP)
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Species:
- other: Rabbit (New Zealand White)
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The test material as supplied was moistened with 0.5 ml of distilled water.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: (related to all animals)
- Other effects:
- Grade 1 erythema observed in 2 animals at 1 hour only.
- Interpretation of results:
- other: 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Species:
- other: Rabbit (New Zealand White)
- Amount / concentration applied:
- 41 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 72h
- Score:
- 0.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 48 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 72h
- Score:
- 0.3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; rvJax. 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 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Conjunctival redness and chemosis were observed at 1 hour
reading (max grade 2) - Interpretation of results:
- other: 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/Corrosion
Two skin irritation in vivo studies carried out in the rabbit were available. In the supporting study (OECD 404, GLP), 6 rabbits were dermally exposed (semi-occlusive) to 46 mg of the test substance in liquid paraffin for 4 hrs. Erythema (max score: 2, reversible within 3 days) was indicated and no odema.
In the primary dermal irritation key study (Annex V/ GLP), 3 rabbits (New Zealand White) were dermally exposed (semi-occlusive) to 0.5g of the test substance moistened with water for 4 hrs. Grade 1 erythema was observed in 2 animals at 1 hour only. The substance was considered non-irritating in the in vivo skin irritation/corrosion test.
Serious eye damage/eye irritation
Two eye irritation in vivo studies carried out in the rabbit were available. In the supporting study (OECD 405, GLP), 6 rabbits were exposed to 20 mg of the test substance. The following effects were noted: conjunctival redness (max score: 2; max. duration: 72hrs); chemosis (max score: 2; max. duration: 24hrs); cornea (max score: 1; max. duration: 24hrs); iris (max score: 1; max. duration: 24hrs). The changes were fully reversible within 7 days.
In a primary eye irritation key study (Annex V/GLP), 41 mg test substance was instilled into the eye of 3 rabbits (New Zealand White). The following effects were noted: conjunctival redness (max score: 1; max. duration: 48hrs); chemosis (max score: 1; max. duration: 24hrs). Conjunctival redness and chemosis were observed at 1 hour reading (max score 2) and all observed effects were fully reversible within 3 days. The substance was considered non-irritating in the in vivo eye irritation test when compared to the classification criteria in the CLP Regulation.
Justification for selection of skin irritation / corrosion endpoint:
According to OECD 404 (Acute Dermal Irritation/Corrosion), a dose of 0.5 g of solid or paste is applied to the test site. In the key study the amount of substance applied was 0.5g while in the supporting study the amount of substance applied was 46mg. The key study was selected as it adhered more closely to the current OECD guideline
Justification for selection of eye irritation endpoint:
According to OECD 405 (Acute eye irritation/corrosion), the maximum amount of solid substance that may be applied is 100mg. In the key study the amount of substance applied was 41mg while in the supporting study the amount of substance applied was 20mg. The key study was selected as it adhered more closely to the current OECD guideline.
Justification for classification or non-classification
Based on the available information in the dossier, the substance Flyadd-3 (CAS No. 135861-56-2) does not need to be classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.
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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