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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
Endpoint summary
Administrative data
Description of key information
Acute toxicity: oral
The key study (Kynoch, 1984) was conducted according to the OECD 401 guideline and was given a reliability score of 2 according to the criteria of Klimisch et al, 1997, based upon the level of reporting. The study reported an LD50 value of 24mg/kg bw for the registered substance.
Acute toxicity: dermal
The key study (Kynoch, 1984) was conducted according to the OECD 402 guideline and was given a reliability score of 2 according to the criteria of Klimisch et al, 1997, based upon the level of reporting. The study reported an LD50 value of 217.5mg/kg bw for the registered substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 24 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 217.5 mg/kg bw
Additional information
Acute toxicity: oral
The key study for the oral route (Kynoch, 1984) was conducted according to the OECD 401 guideline and was performed on male and female rats at dose levels of 64, 100 and 160 mg/kg bodyweight. The rats were observed for 14 days in the main study for mortality, clinical signs and bodyweight changes. At the end of the observation period all animals were subject to a gross necropsy. Mortalities occurred in all 3 dose groups within 3 hours of the study initiation, and clinical signs of systemic toxicity were observed shortly after dosing. Bodyweights were slightly reduced in rats with unscheduled deaths, however surviving rats exhibited body weight gains on days 8 and 15. Gross necropsy revealed congestion of the lungs and pallor of the liver, kidneys and spleen amongst animals that died during the study, while surviving animals exhibited normal organ appearance.
Based upon the evidence of the study the LD50 value for acute oral toxicity was set at 24 mg/kg bw. The supporting studies provide similar LD50 values of 27 mg/kg bw (Harper & Ginn, 1964), between 25 and 40 mg/kg bw (Bough et al, 1963) and 5 and 60 mg/kg bw (Spencer et al, 1948) for acute oral toxicity to the registered substance, however these studies are considered of lesser reliability due to age of the study reports and deviations from recognised testing methods.
Acute toxicity: dermal
The key study for the dermal route (Kynoch, 1984) was selected as the most recent and reliable study available. The key study was conducted according to the OECD 402 guideline and performed on male and female rats at doses of 500, 640, 800, 1260 and 2000 mg/kg with exposure duration of 24 hours. The animals were observed for 14 days in the main study for mortality, clinical signs of toxicity and bodyweight. At the end of the observation period all animals were subject to gross necropsy.
Mortalities were observed within 4 hours of exposure at dose levels of 640mg/kg bw and above. Clinical signs were noted during the first 24 hours of the exposure but by day 3 all surviving animals have recovered completely. Bodyweights of animals which died during the exposure and observation periods were reduced, however bodyweights of surviving animals were normal the end of the observation period. The study reported an LD50 value of 217.5mg/kg for male and female animals. Similar results are reported by Bough et al, 1963, where 2 of 10 animals died at a dose of 100mg/kg bw and nine of ten at a dose of 500 mg/kg bw, and Spencer et al, 1948, where the LD0 was set at 100mg/kg bw and the LD100 set at 500 mg/kg bw.
Much lower LD50 values were reported by Kynoch & Lloyd, 1976, and Kynoch and Lloyd, 1977, where the LD50 values were set at 30mg/kg bw and 47.7mg/kg bw respectively. These studies were considered to be of reduced reliability based upon the criteria of Klimisch et al, 1977, and so were not considered for the chemical safety assessment.
Justification for classification or non-classification
Based upon the above information the substance meets the criteria for classification as set out by both 67/548/EEC and EC Regulation 1272/2008 and should therefore be classified as follows:
R28 toxic if swallowed and R24 toxic in contact with skin;
Acute oral category 2, H300 Fatal if swallowed, Acute dermal category 3, H311 Toxic in contact with skin
It should also be noted that the official Annex I classification for the substance is given as R25 as opposed to R28. In light of the official classification and the proximity of the oral LD50 to the threshold value, the registrant proposes to retain the more severe classification.
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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