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EC number: 421-920-2 | CAS number: 154862-43-8
- 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
Subacute NOAEL (rat, male/female): 200 mg/kg bw/day (Directive 92/69 EEC, B.7/GLP)
Subacute NOEL (rat, male/female): 200 mg/kg bw/day (Directive 92/69 EEC, B.7/GLP)
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Compliance, not OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69 EEC, B. 7
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- Method of administration: gavage
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 10 animals at 500 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day - Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no test article-related clinical signs noted in any dose group.
- Mortality:
- no mortality observed
- Description (incidence):
- All animals survived the scheduled treatment period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There was no effect on body weights.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption was uneffected by treatment with test article.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Ophthalmologic findings were noted in a small proportion of animals from all groups. They included corneal opacity and degeneration of the eyes. These findings occured at similar incidences in the control and treated groups at the end of the treatment period. Therefore, they are considered to be unrelated to treatment with test article.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related effects on hematology, clinical biochemistry and urinalysis data at termination of the treatment nor at the end of the treatment free recovery period which could be considered of toxicological significance.
However a few minor findings with statistical significance were recorded between the control and treated rats of group 4 at termination of the treatment and/or recovery period. The toxicological relevance of these statistical findings is considered to be doubtful. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related effects on hematology, clinical biochemistry and urinalysis data at termination of the treatment nor at the end of the treatment free recovery period which could be considered of toxicological significance.
However a few minor findings with statistical significance were recorded between the control and treated rats of group 4 at termination of the treatment and/or recovery period. The toxicological relevance of these statistical findings is considered to be doubtful. - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment related effects on hematology, clinical biochemistry and urinalysis data at termination of the treatment nor at the end of the treatment free recovery period which could be considered of toxicological significance.
However a few minor findings with statistical significance were recorded between the control and treated rats of group 4 at termination of the treatment and/or recovery period. The toxicological relevance of these statistical findings is considered to be doubtful. - Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Organ weights were uneffected by treatment with test article.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Most macroscopic findings recorded were unremarkable and within the range of spontaneous alterations which may be seen in rats of this age and strain.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Chiefly minor degrees of hepatocellular vacuolization representing slight hepatic lipidosis, were noted in the liver of both control and treated rats at both sacrifices. This was considered to be due to the vehicle, corn oil.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Information from migrated NONS file, as per inquiry number 06-2120077351-60-0000, permission to refer granted by ECHA.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity (oral)
There is one 28 day repeated dose toxicity study in rats available.
In a sub-acute toxicity study (Directive 92/69 EEC, B.7/GLP), 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane was administered by oral gavage to Sprague Dawley rats (5/sex/group) in corn oil at 0, 62.5, 200 or 500 mg/kg bw/day for 28 days, 7 days per week.
After 28 days test duration, all animals survived the scheduled treatment period. There were no effect on body weights or food consumption. There were no test article-related clinical signs noted in any dose group.
Ophthalmologic findings were noted in a small proportion of animals from all groups. They included corneal opacity and degeneration of the eyes. These findings occured at similar incidences in the control and treated groups at the end of the treatment period. Therefore, they are considered to be unrelated to treatment with test article. There were no treatment related effects on hematology, clinical biochemistry and urinalysis data at termination of the treatment nor at the end of the treatment-free recovery period which could be considered of toxicological significance. However a few minor findings with statistical significance were recorded between the control and treated rats of group 4 at termination of the treatment and/or recovery period. The toxicological relevance of these statistical findings is considered to be doubtful.
Organ weights were unaffected by treatment with test article. Most macroscopic findings recorded were unremarkable and within the range of spontaneous alterations which may be seen in rats of this age and strain. Chiefly minor degrees of hepatocellular vacuolization representing slight hepatic lipidosis, were noted in the liver of both control and treated rats at both sacrifices. This was considered to be due to the vehicle, corn oil. The NOAEL for repeated dose toxicity in males and females was established as 200 mg/kg bw/day (nominal). The NOEL for repeated dose toxcity in males and females was established as 200 mg/kg bw/day (nominal).
Justification for classification or non-classification
Based on available information in the dossier, the substance 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane (CAS No. 154862-43-8) does not need to be classified for specific target organ toxicity (repeated) when considering the criteria outlined in Annex I of 1272/2008/EC.
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