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Diss Factsheets
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EC number: 917-830-2 | CAS number: 1186514-91-9
- 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
No adverse effects observed in a 28-day repeated dose toxicity test in rats at doses up to 1000 mg/kg bw/d.
Key value for chemical safety assessment
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:
- supporting study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Preliminary study to guideline study, in the spirit of GLP
- Qualifier:
- no guideline available
- Version / remarks:
- 14-day dose range finding study for OECD 422
- Principles of method if other than guideline:
- 14-day dose-range finding study for the OECD 422 study
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.8 - 26.0°C (target: 22 ± 3 °C)
Relative humidity: 35 - 70% (target: 30 - 70%)
Ventilation: 15-20 air exchanges/hour
Housing/Enrichment: Rodents were housed up to 5 animals of the same sex per cage
Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice
Water was provided ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Daily
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 males and 5 females per group were tested at each dose concentration
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- Animals were inspected for signs of morbidity and mortality twice daily (at the beginning and end of each working day). Clinical observations were made twice daily, before and after treatment, at the beginning and towards the end of the working day as practical.
- Sacrifice and pathology:
- On Day 14, after an overnight period of food deprivation of the surviving animals, blood samples were collected from all animals immediately prior to the scheduled necropsy by heart puncture under pentobarbital anaesthesia.
- 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
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- NOAEL > 1000 mg/kg bw/d
- Key result
- Critical effects observed:
- no
- Conclusions:
- ZEF 6099/100 administered by oral gavage to Wistar rats for 14 consecutive days at dose levels of 100, 300 or 1000 mg/kg bwt/day in olive oil had no adverse effects. The NOAEL was greater than 1000 mg/kg bw/d.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- adequate
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
Mode of Action Analysis / Human Relevance Framework
Not applicable; no significant toxicity observed.
Additional information
In an OECD 422 guideline study of ZEF 6099/100 in the Wistar rat at oral doses of 100, 300 and 1000 mg/kg bw/d, the test material did not result in adverse effects in clinical signs, body weight, organ weights, food consumption, neurological assessment, haematology, coagulation, clinical chemistry, urinalysis, or gross/histopathology. There were no effects in reproductive parameters nor in F1 offspring viability, clinical signs, development or macroscopic examination. The NOAEL is greater than 1000 mg/kg bw/d.
Justification for classification or non-classification
In repeated oral (gavage) dose toxicity testing in the rat for 28 days according to the OECD 422 method, no significant toxicity was observed. The NOAEL is greater than the highest dose tested, 1000 mg/kg bw/d. The criteria for Regulation EC No. 1272/2008 for classification for specific organ toxicity, repeated exposure, or for other hazards not included in the STOT-RE classification scheme, are not met. The substance is not classified.
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