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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
Toxicity (Oral): LD 50 = >5000 mg/kg bw (OECD 401; GLP)
Toxicity (Dermal): LD 50 = >2000 mg/kg bw (Annex V; GLP)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD method, GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 401 (1987) 21 CFR 58 (FDA) C(81 )30 (Final) (OECD)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- other: Albino rat
- Vehicle:
- corn oil
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
Soft stools were noted in 2 females on the day of treatment
only. This was not considered as remarkable. - Gross pathology:
- Effects on organs:
No remarkable findings. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Information from migrated NONS file, as per inquiry number 06-0000020961-70-0000, permission to refer granted by ECHA
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Annex V Guideline study with GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- other: Rat (Sprague Dawley)
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The substance as supplied was applied to skin which was moistened with arachis oil B.P.
- Duration of exposure:
- 24 h
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
No signs of systemic toxicity were noted during the study period. No toxicologically significant effects on bodyweight were noted during the study. - Gross pathology:
- Effects on organs: No abnormalities were noted at necropsy of animals killed at the end of the study.
- Other findings:
- Signs of toxicity (local):
No signs of dermal irritation were noted during the study period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Information from migrated NONS file, as per inquiry number 06-0000020961-70-0000, permission to refer granted by ECHA
Additional information
Acute Toxicty: Oral
Two acute oral toxicity studies in the rat were available. In the supporting study (Annex V B1, GLP), there were no mortalities and no treatment-related clinical signs; the LD50 was >5000 mg/kg bw. In the acute oral toxicity key study (OECD 401/GLP), groups of rats (Albino; 5/sex) were given a single oral dose of Flyadd-3 in corn oil at a dose of 5000 mg/kg bw.
Oral LD50 Males/Females = >5000 mg/kg bw
No deaths were observed and there were no other treatment-related effects noted. The LD50 value for the acute oral toxicity endpoint is >5000mg/kg bw.
Acute Toxicity: Dermal
Two acute dermal toxicity studies in the rat were available. In the supporting limit test study (OECD 402, GLP) groups of rats (Sprague Dawley; 5/sex) were dermally exposed (semi-occlusive) to the test substance in liquid paraffin for 24 hrs at a dose of 2,000 mg/kg bw. No deaths occurred and no signs of toxicity (systemic or local) were observed.
In the acute dermal toxicity key study (Annex V/GLP), groups of rats (Sprague Dawley; 5/sex) were dermally exposed (semi-occlusive) to the test substance (skin was moistened with arachis oil B.P.) for 24 hrs at a dose of 2,000 mg/kg bw.
Dermal LD50 Males/Females = >2,000 mg/kg bw
No deaths occurred and no signs of toxicity (systemic or local) were observed. There were no toxicologically significant effects on bodyweight and no abnormalities were noted at necropsy of animals killed at the end of the study. The LD50 value for the acute dermal toxicity endpoint is >2000mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Only 1 key study available
Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH annex VIII, the information under 8.5.2 and 8.5.3 shall be provided for at least one other route in addition to the oral route. As there is already information about 8.5.1 and 8.5.3, the acute inhalation test does not need to be conducted.
Justification for selection of acute toxicity – dermal endpoint
Although the supporting study was OECD guideline and GLP compliant, there was brief supporting documentation that was inconsistent. The key study chosen was an Annex V guideline study with GLP compliance which provided a clear description of the study results.
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 acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in the CLP Regulation (Annex I of 1272/2008/EC) are applied.
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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