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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-reported, GLP-compliant study of close chemical analogue, using methods similar to those of the relevant OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Twice daily observation and opthalmoscopy during treatment period, but no functional observation battery.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Polysaccharide gum K9A50
- IUPAC Name:
- Polysaccharide gum K9A50
- Details on test material:
- K9A50: gellan gum (EC 275-117-5): high polysaccharide content.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Individually housed in stainless steel, wire mesh cages. Tapwater and powdered diet freely available, 12 hour/12 hour dark cycle (temperature and humidity controlled). Bodyweights 121-141g (males) 100-118g (females) 7 days prior to treatment.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: powdered basal diet
- Details on oral exposure:
- Test diets mixed weekly in blender.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity and stability of test substance in diet confirmed in pilot study prior to this 13-week toxicity study. Samples taken during treatment weeks 1,6,10,13 and achieved concentrations confirmed by analysis.
- Duration of treatment / exposure:
- Continuous exposure via diet for 13 weeks.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
3.0%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
4.5%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
6.0%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 20 males, 20 females.
- Control animals:
- yes, plain diet
- Details on study design:
- 2-week acclimation pre-treatment; satellite group (health screen, 10 males + 10 females) terminated pre-treatment.
- Positive control:
- No.
Examinations
- Observations and examinations performed and frequency:
- Mortality checked twice daily; clinical signs recorded once daily.
Bodyweights and food consumption recorded pre-treatment and weekly during treatment.
Opthalmoscopy checks (control and high-dose groups) pre-treatment and prior to termination.
Haematology, blood chemistry, urinalysis checked pre-treatment (health screen satellite group) and (together with faecal moisture content) in weeks 6 and 12 of treatment period (10 or 12 rats/sex/group). - Sacrifice and pathology:
- Termination was by CO2 asphyxiation followed by exsanguination. Full postmortem at necropsy with organ weights (adrenals, brain, heart, kidneys, liver, ovaries, pituitary, spleen, tested, thyroid and parathyroid).
Full tissue list taken and fixed, femoral bone marrow smears prepared and stained.
Histopathology examinations on all tissue taken from control and high group rats.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Small increases in neutrophil counts in treated males achieved statistical significance compared to controls but were considered not to be of toxicological significance.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No toxicologically significant differences from controls were recorded in test groups.
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No toxicologically significant differences from controls were recorded in test groups.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Some cases of reddened stomach mucosa were noted (maximum 4 males, 1 female at 6%) but histopathological examination found no abnormalities.
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- For about 1 week mid-study, most animals showed symptoms of viral infection (syalodacryoadenitis) but all recovered, showing no residual effects.
No adverse reactions top treatment were seen.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 6 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No evidence of toxicity seen in any test group. Achieved intake at 6% in diet was 2.95-7.26 g/kg/day (according to sex and week of the test period).
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Achieved intake of test substance by rats given 6% in diet was calculated to be:
- in males, 6.99 g/kg/day in week 1, 2.95 g/kg/day in week 13
- in females, 7.26 g/kg/day in week 1, 3.76 g/kg/day in week 13.
Applicant's summary and conclusion
- Conclusions:
- Rats fed 6% gellan gum in diet for 13 weeks (corresponding to daily intakes ranging from 2.95 to 7.26 g/kg/day) showed no evidence of treatment related toxicity. It is reasonable to predict that a similar pattern of low subchronic toxicity would be seen if Diutan were to be tested in the same way.
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