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Diss Factsheets
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EC number: 425-950-7 | CAS number: 187393-00-6
- 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
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Carcinogenicity
Administrative data
Description of key information
2 year Dermal NOAEL: >= 1000 mg/kg bw/day
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Justification for classification or non-classification
The present data on carcinogenicity do not fulfill the criteria laid down in regulation (EU) 1272/2008 and therefore, a non-classification is warranted.
Additional information
In the chosen key study for carcinogenicity, i.e. a dermal carcinogenicity study in Wistar rats (acc. to OECD TG 451), three test-treated groups of 100 Wistar Han rats (50 males and 50 females) received Bemotrizinol at 100, 500 or 1000 mg/kg/day by daily cutaneous application for 104 weeks (CIT 25382; 2006). Another group of 50 males and 50 females received no treatment and acted as an untreated control group. An additional group of 50 males and 50 females received the vehicle alone (polyethylene glycol 400) under the same experimental conditions and acted as vehicle control group. The animals were checked daily for mortality, clinical signs and possible signs of skin irritation. The animals were palpated every 2 weeks after 6 months of treatment in order to monitor the onset and progression of any masses. Body weight and food consumption were recorded at designated intervals (weekly during the first 3 months of treatment and then monthly). Ophthalmological examinations were performed on all the animals before the beginning of the treatment period and on 10 animals/sex in the vehicle control and high-dose groups in weeks 26, 52, 78 and 103. The differential white cell count was determined in weeks 52 and 78 for the animals in the vehicle control and high-dose groups. Blood samples for the determination of plasma levels of the test item were taken in weeks 13, 26, 52, 78 and 104. On completion of the treatment period, blood samples were taken from 10 animals/sex and group for hematology and blood biochemistry investigations. All surviving animals were euthanized and submitted to a macroscopic post-mortem examination. Designated organs and any masses or lesions were sampled from each animal and retained for microscopic examination.
The survival rate was not affected by treatment with Bemotrizinol. There were no clinical signs and no effects on body weight or food consumption at any dose-level. At laboratory investigations, no differences among hematological and blood biochemical parameters were attributed to treatment with Bemotrizinol. The systemic exposure seemed similar among the test item treated groups whatever the dose-level applied. Bemotrizinol induced dose-related non-neoplastic skin lesions at the treated skin from 100 mg/kg/day. The pattern of changes was indicative of chronic moderate skin irritation. No other non-neoplastic or neoplastic organ changes were attributed to treatment with Bemotrizinol. Overall, the daily treatment with Bemotrizinol for 104 weeks induced only non-neoplastic findings at the treated skin area indicative of a chronic and moderate local skin irritation.
Consequently, under the experimental conditions of the study, Bemotrizinol, was not carcinogenic by cutaneous application at 100, 500 and 1000 mg/kg/day (CIT, 2006)
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