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Diss Factsheets
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EC number: 439-070-6 | CAS number: 125005-87-0
- 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
A 4-week oral toxicity study of Diutan found no evidence of toxicity at the maximum tested dosage of 1000 mg/kg/day.
The closely similar chemical analogue gellan gum has shown similarly low toxicity in a variety of repeat-dose studies, performed in different species. In a 13-week rat study, administration of gellan gum at up to 6% in the diet found no evidence of toxicity: the NOAEL of 6% in diet equated to achieved test substance intake s of 6.99-2.95 g/kg/day (males), 7.26-3.76 g/kg/day (females). In a 96-98 week mouse carcinogenicity study, feeding gellan gum at up to 3% in diet (overall achieved intakes 4.9 g/kg/day (males), 6.2 g/kg/day (females)) produced no overt signs of toxicity and no adverse histopathology findings. To support the use of gellan gum as a food additive, it has also been investigated using less commonly performed repeat-dose test protocols. Toxicology Monograph 724 (Food Additive Series 28, 1990) of the Joint FAO/WHO Expert Committee on Food Additives describes:
- a carcinogenicity study using rats exposed to gellan gum in utero then fed for 2 further years at up to 5% in the diet, which found no neoplastic or non-neoplastic changes associated with test exposure
- a 52-week beagle dog study using levels up to 6% in the diet which found no effect of treatment
- a 28-day rhesus monkey study giving oral doses up to 3 g/kg/day which found no overt signs of toxicity.
It is reasonable to predict that Diutan would show a similar pattern of low toxicity in subchronic and chronic toxicity studies.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 4 900 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The cited subchronic NOAEL value cited is selected as key for chemical safety assessment because this is both:
- the lower of the two overall mean achieved dosages (for male and females) corresponding to the mouse 96 -98 week carcinogenicity study NOAEL, and
- the lower of the two mean achieved dosages (for male and females) in the 13 -week rat toxicity study (calculated as simple means of the week 1 and week 13 intakes: mean (males) = 4.97 g/kg/day).
Justification for classification or non-classification
Based on the demonstrated low toxicity of both Diutan and its close analogue gellan gum, no classification in respect of repeated dose toxicity is appropriate.
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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