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EC number: 806-731-9 | CAS number: 1428353-74-5
- 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
GLP guideline studies are availalbe for both skin and eye irritation for the notified substance.
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:
- June 12, 2015 to September 23, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Reversibility:
- other:
- Remarks:
- Slight erythema was present in one animal throughout the study period. Erythema reversed in remaining two animals by day 14
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Reversibility:
- other:
- Remarks:
- Not present in 2 animals. Did not reverse in one animal through study period of 21 days.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Primary Irritation Index (PII) for SP5076 was 1.8. The Draize scores at 24, 48, and72 hours after patch removal for erythema and edema for individual animals were:Erythema:Animal 1 (24, 48, 72 hr): 1, 2, 2Animal 2 (24, 48, 72 hr): 2, 2, 2Animal 3 (24, 48, 72 hr): 2, 2, 2EdemaAnimal 1 (24, 48, 72 hr): 0, 0, 0Animal 2 (24, 48, 72 hr): 0, 0, 1Animal 3 (24, 48, 72 hr): 0, 0, 0
- Executive summary:
The substance resulted in a 24 -72 hr mean erythema and edeam score of 1.89 and 0.06, respecitively and does not meet the CLP criteria for classification as a skin irritant. This was a GLP OECD 404 guideline study. There were no deaths or remarkable body weight changes noted during the study. All 3 rabbits had very slight erythema to slight erythema, and only 1 of these rabbits had very slight to slight edema. While erythema had resolved by study day 14 for 2 of the rabbits, very slight erythema and slight edema were still present at the last observation period (study day 21) for the remaining rabbit. The only other dermal finding was desquamation on study day 14 for 2 rabbits.
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
- Study period:
- February 17, 2016 to May 4, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- study period (unwashed)
- Observation period (in vivo):
- 17 days
- Duration of post- treatment incubation (in vitro):
- unwashed
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The 24-, 48-, and 72-hour post-instillation Draize scores for SP5076 were 18.7/110, 17.0/110, and 17.7/110, respectively. All positive ocular irritation subsided by study day 14.
- Executive summary:
In a GLP guideline study, the substance caused irritation that meets the CLP criteria for classification as category 2A. There were no deaths or remarkable body weight changes noted during the study. The only clinical observations noted during the study were ocular-related and consisted mainly of partial and/or complete closure of the right eye. Positive corneal irritation, conjunctival irritation, and iridal irritation were noted for all rabbits. Iridal and corneal irritation subsided by study day 4 and 14, respectively. Positive conjunctival irritation subsided by study day 7; however, conjunctival redness did not subside until study day 17. Clear discharge was noted in all 3 rabbits and subsided by 72 hours post-instillation. Two of 3 rabbits had some fluorescein staining noted at 24 hours post-instillation which subsided by study day 4.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN
The substance resulted in a 24 -72 hr mean erythema and edeam score of 1.89 and 0.06, respecitively and does not meet the CLP criteria for classification as a skin irritant. This was a GLP OECD 404 guideline study. There were no deaths or remarkable body weight changes noted during the study. All 3 rabbits had very slight erythema to slight erythema, and only 1 of these rabbits had very slight to slight edema. While erythema had resolved by study day 14 for 2 of the rabbits, very slight erythema and slight edema were still present at the last observation period (study day 21) for the remaining rabbit. The only other dermal finding was desquamation on study day 14 for 2 rabbits.
EYE
In a GLP guideline study, the substance caused irritation that meets the CLP criteria for classification as category 2A. There were no deaths or remarkable body weight changes noted during the study. The only clinical observations noted during the study were ocular-related and consisted mainly of partial and/or complete closure of the right eye. Positive corneal irritation, conjunctival irritation, and iridal irritation were noted for all rabbits. Iridal and corneal irritation subsided by study day 4 and 14, respectively. Positive conjunctival irritation subsided by study day 7; however, conjunctival redness did not subside until study day 17. Clear discharge was noted in all 3 rabbits and subsided by 72 hours post-instillation. Two of 3 rabbits had some fluorescein staining noted at 24 hours post-instillation which subsided by study day 4.
Justification for classification or non-classification
Skin
In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material is not classified for skin irritation.
Eye
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material is classified as an eye irritant, category 2A.
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