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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
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Endpoint summary
Administrative data
Description of key information
Based on these results a parental NOAEL for systemic effects of 500 mg/kg bw/d was derived.
Key value for chemical safety assessment
Additional information
IFF 05-0293 was administered via oral gavage to male and female Wistar Han rats at doses of 50, 150 and 500 mg/kg bw/d in corn oil (10 rats/sex/dose level) according to OECD 422 Guideline. Concurrent controls (10 rats/sex) received the vehicle. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 40-53 days, i.e. during 2 weeks prior to mating, during mating, during postcoitum, and during at least 4 days of lactation. Accuracy, homogeneity and stability of formulations were demonstrated by analyses.
No mortality or toxicologically related clinical signs were noted. No treatment-related effects on body weight, food consumption, functional behaviour, haematology, and macroscopy were observed.
An adverse histopathological lesion was recorded in the kidneys of males in all treatment groups. In these males, an increased incidence and severity (up to slight) of hyaline droplet accumulation was noted. The hyaline droplet accumulation was considered to likely represent alpha-2u-globulin, a normal protein in male rats which undergoes reabsorption in the proximal cortical tubules. A range of chemicals is known to increase hyaline droplet formation leading ultimately to proximal cortical tubule cell injury as manifested by formation of granular casts and increased tubular basophilia. This male rat specific protein is not present in female rats nor in higher mammals, including man. In this study the increased hyaline droplet accumulation in males was accompanied by indicators of renal tubular damage in the form of granular casts at minimal to slight degree (50 and 500 mg/kg bw/d). This combination of findings was considered to be non-adverse.
Histopathology showed a minimal or slight hepatocellular hypertrophy of the centrilobular areas of the liver for both sexes at 150 and 500 mg/kg bw/d. This histopathological observation was accompanied by higher liver weights in males at 150 mg/kg bw/d (relative weight approximately 17% higher) and in males and females at 500 mg/kg bw/d(relative weight approximately 32% and 15% higher, respectively). These findings occurred without any degenerative histopathological changes or corroborative changes in clinical biochemistry parameters and were therefore considered to be an adaptive, non-adverse finding. Other histopathological changes that were considered to be related to treatment but were considered not adverse in nature were recorded in the adrenal and thyroid glands. Follicular cell hypertrophy as recorded in the thyroid gland of males at 150 and 500 mg/kg bw/d with a minor increase in severity (slight degree) was regarded to be an adaptive change and considered to be non-adverse at the incidences and severities recorded. An increased incidence and severity of vacuolation of the zona glomerulosa of the adrenal glands was seen in females at 500 mg/kg bw/d. Given the slight nature of vacuolation of the zona glomerulosa of the adrenal glands, and absence of any degenerative findings, this was considered to be non-adverse. Additionally, higher adrenal gland weights were present in the opposite sex at 150 and 500 mg/kg bw/d, and were approximately 29% higher at both dose levels. In absence of any morphological support, the higher adrenal gland weight was considered not adverse in nature. Statistically significant changes in clinical biochemistry parameters consisted of higher total protein in males at 50 mg/kg bw/d and higher, higher creatinine and calcium in males at 500 mg/kg bw/d and higher chloride in females at 500 mg/kg bw/d. These changes were considered not toxicologically relevant since no (clear) dose-related trend was noted, changes were generally minor in nature (within the range considered normal for rats of this age and strain), and no apparent relation to morphological lesions described above was seen.
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 repeated dose toxicity in accordance with Regulation (EC) No. 1272/2008.
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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