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EC number: 944-610-3 | CAS number: 286472-48-8
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Based on the absence of adverse effects on male and female fertility and reproductive performance, the NOAEL was determined to be 500 mg/kg in an combined 28 day repeated dose toxicity study with reproductive/developmental screening assay according to OECD TG 422.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Additional information
IFF 05-0293 was administered by daily oral gavage to male and female Wistar Han rats at dose levels
of 50, 150 and 500 mg/kg. Males were exposed for 2 weeks prior to mating, during mating, and up to
termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating,
during post-coitum, and at least 4 days of lactation (for 40-53 days).
Formulation analysis showed that the formulations were prepared accurately and homogenously.
Reproductive results:
No reproduction toxicity was observed up to the highest dose level tested (500 mg/kg).
No treatment-related changes were noted in any of the reproductive parameters investigated in this
study (i.e. mating, fertility and conception indices, precoital time, and numbers of corpora lutea and
implantation sites, spermatogenic profiling, and histopathological examination of reproductive organs).
Three control females did not deliver offspring; two were not pregnant and one control female showed
no evidence of mating, No abnormalities were seen in the reproductive organs, which could account
for their lack of offspring. It was considered that sufficient control data were available to allow for a
valid interpretation of the study data, also considering the absence of reproductive and developmental
toxicity up to the highest dose tested in this study.
Developmental results:
No developmental toxicity was observed up to the highest dose level tested (500 mg/kg).
No treatment-related changes were noted in any of the developmental parameters investigated in this
study (i.e. gestation index and duration, parturition, maternal care and early postnatal pup
development consisting of mortality, clinical signs, body weight and macroscopy).
In conclusion, treatment with IFF 05-0293 by oral gavage in male and female Wistar Han rats at dose
levels of 50, 150 and 500 mg/kg revealed adverse parental effects in males only, consisting of
degenerative lesions in the kidneys at 50 mg/kg and higher. No reproduction and developmental
toxicity was observed for treatment up to 500 mg/kg.
Based on these results, the following No Observed Adverse Effect Levels (NOAEL) were derived:
Parental NOAEL (males): - below 50 mg/kg (based on degenerative kidney lesions (i.e. granular
casts and tubular basophilia, related to hyaline droplet accumulation)
- At least 500 mg/kg, when male rat specific kidney findings are
disregarded.
Parental NOAEL (females): at least 500 mg/kg
Reproduction NOAEL: at least 500 mg/kg
Developmental NOAEL: at least 500 mg/kg
Justification for classification or non-classification
Based on the results of the combined oral repeated dose toxicity study and reproduction/developmental toxicity screening test, the test substance does not have to be classified for reproduction toxicity in accordance with Regulation (EC) No. 1272/2008.
Additional information
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