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EC number: 253-211-7 | CAS number: 36788-39-3
- 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
Guideline OECD 422 oral study in rats
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- System:
- male reproductive system
- Organ:
- testes
Additional information
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Polyethylene glycol 400) over the same treatment period and at the same dosage volume. At 1000 mg/kg bw/day there was a clear effect on fertility leading to only a single pregnancy which appeared to be attributable to treatment-related effects on the testes and epididymides. Although pregnancy rate was satisfactory at lower dosages, treatment-related effects were apparent for the testes and epididymides at 300 mg/kg bw/day and the testes at 100 mg/kg bw/day.
A No Observed Adverse Effect Level (NOAEL) for male testicular effects could not therefore be established.
For females, there were no findings apparent at 300 mg/kg bw/day that were considered to preclude this dosage from being a NOAEL for systemic toxicity or for reproduction.
Justification for classification or non-classification
In a Guideline OECD 422 screening study, at 1000 mg/kg bw/day there was a clear effect on fertility leading to only a single pregnancy which appeared to be attributable to treatment-related effects on the testes and epididymides. Although pregnancy rate was satisfactory at lower dosages, treatment-related effects were apparent for the testes and epididymides at 300 mg/kg bw/day and the testes at 100 mg/kg bw/day. A No Observed Adverse Effect Level (NOAEL) for male testicular effects could not therefore be established.
For females, there were no findings apparent at 300 mg/kg bw/day that were considered to preclude this dosage from being a NOAEL for systemic toxicity or for reproduction.
Based on the finding of testicular degeneration in the OECD 422 oral study, the test item is classified in Category 2 for target organ toxicity (repeat exposure) according to the criteria described in Regulation (EC) No 1272/2008.
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