Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 201-861-7 | CAS number: 88-85-7
- 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
Carcinogenicity
Administrative data
Description of key information
The key study (Brown, 1981) was conducted in a way similar to the OECD 453 guideline. Although the study predates the guideline and deviates from it in minor ways the study was considered to be of sufficient reliability (reliability score of 2 according to the criteria of Klimisch et al, 1997) to fulfil the regulatory requirement and be used as a basis for classification and labelling. The study was conducted on the mouse (male and female) using a feeding methodology with concentrations present in feed to obtain 1, 3 and 10 mg/kg bw/day dose levels. In addition to test groups a negative control group (plain diet) was used to verify the validity of the study result.
Animals were dosed for 100 weeks after which all animals were subject to gross necropsy. Unscheduled deaths during the study period were also subject to gross necropsy. In addition to this animals were also observed for appearance, behaviour, general observations, bodyweight, food consumption, water consumption, opthalmology, haematology, blood chemistry and urine analysis during the study period and histological examination of tissues after termination.
Treatment affected body weight changes in females, and resulted in opthalmological effects during the test period. Although an increased incidence of hepatocellular tumours was observed in treated female mice, this was considered to not be a carcinogenic response because no increased incidence was noted in males; neoplasms in females were only observed in the terminal stage of the study (week 96 onwards) and there was no evidence of any early significant mortality associated with neoplasia; a zero incidence, a relatively unusual event in the majority of chronic mouse studies at the performing laboratory, was recorded in control females; no dose-relationship was apparent; and no pre-neoplastic lesions were noted.
Based upon these effects the NOAEL for carcinogenicity was set at 10mg/kg bw/day, the highest dose level tested.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
Justification for classification or non-classification
Dinoseb was considered not to be carcinogenic in mice.
Additional information
The available data was considered to be adequate to fulfil the regulatory requirement and to be used as a basis for classification and labelling.
Carcinogenicity: via oral route (target organ): cardiovascular / hematological: lymph nodes; digestive: liver; respiratory: lung
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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