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EC number: 700-178-6 | CAS number: 121627-17-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP Study, very well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 9-[(3,3'-di-tert-butyl-2'-{8,10-dioxa-9-phosphatricyclo[9.4.0.0²,⁷]pentadeca-1(11),2(7),3,5,12,14-hexaen-9-yloxy}-5,5'-dimethoxy-[1,1'-biphenyl]-2-yl)oxy]-8,10-dioxa-9-phosphatricyclo[9.4.0.0²,⁷]pentadeca-1(11),2(7),3,5,12,14-hexaene
- EC Number:
- 700-178-6
- Cas Number:
- 121627-17-6
- Molecular formula:
- C46H44O8P2
- IUPAC Name:
- 9-[(3,3'-di-tert-butyl-2'-{8,10-dioxa-9-phosphatricyclo[9.4.0.0²,⁷]pentadeca-1(11),2(7),3,5,12,14-hexaen-9-yloxy}-5,5'-dimethoxy-[1,1'-biphenyl]-2-yl)oxy]-8,10-dioxa-9-phosphatricyclo[9.4.0.0²,⁷]pentadeca-1(11),2(7),3,5,12,14-hexaene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- up to 54 d
- Frequency of treatment:
- 1 per day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
300 mg/kg/day
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
100 mg/kg/day
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1000 mg/kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects were observed for reproduction or for developmental effects in the offspring.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Results and observations
Mortality. There were no unscheduled deaths during the study.
Clinical Observations. No toxicologically significant signs of toxicity were detected throughout the study.
Behavioural Assessment. There were no treatment-related changes in the behavioural parameters measured.
Functional Performance Tests. There were no toxicologically significant changes in functional performance.
Sensory Reactivity Assessments. There were no treatment-related changes in sensory reactivity.
Bodyweight. No adverse effects on bodyweight development were detected for treated animals when compared to controls.
Food Consumption. No adverse effects on food consumption or food efficiency were detected for treated animals when compared to controls.
Haematology. No toxicologically significant effects were detected in the haematological parameters measured.
Blood Chemistry. No toxicologically significant effects were detected in the blood chemical parameters measured.
Reproductive Performance:
Mating and Fertility. There were no treatment-related effects on mating or conception rates.
Gestation Length. There were no treatment-related effects detected in gestation length.
Litter Responses: Offspring Litter Size and Viability. Litter size at birth and subsequently at Days 1 and 4 post partum were comparable to controls.
Offspring Growth and Development. Offspring bodyweight gain and litter weights at birth and subsequently on Day 1 and Day 4 post partum were comparable to controls.
Organ Weights. No toxicologically significant effects were detected in the organ weights measured.
Necropsy. No toxicologically significant macroscopic abnormalities were detected.
Histopathology. No treatment-related changes were detected.
Conclusion.
The oral administration of L17 to rats by gavage, at dose levels of 1000, 300 and 100 mg/kg/day, resulted in treatment-related effects in males from all treatment groups and in females treated with 1000 and 300 mg/kg/day. These effects were considered not to represent an adverse health effect, as such the 'No Observed Adverse Effect Level' (NOAEL) for systemic toxicity was considered to be 1000 mg/kg/day. No treatment-related effects were observed for reproduction or for developmental effects in the offspring, therefore, the ‘No Observed Effect Level’ (NOEL) for reproductive, developmental and teratogenicity toxicity was considered to be 1000 mg/kg/day.
Applicant's summary and conclusion
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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