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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- 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 in vivo absorption, distribution and excretion study of a close chemical analogue.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 3-stage investigation, a single oral dose of radiolabelled test substance being given to rats for each stage:
[1] respired 14CO2 levels determined over 24 hours post-dose
[2] urine and faeces collected and checked for radioactivity over 7 days post-dose, then organs/tissues collected at termination and checked for radioactivity
[3] blood samples collected over 168 hours post-dose and analysed for radioactivity. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Gellan gum
- EC Number:
- 275-117-5
- EC Name:
- Gellan gum
- IUPAC Name:
- Gellan gum
- Details on test material:
- Gellan gum, sample ID EX 4949 radiolabelled as indicated.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C and 3H
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were age 42-49 days on arrival in test laboratory (7 days prior to study start). Individually housed in metal cages, with free access to food and water (except where restricted in test phase). 12-hour light/dark cycle in animal room, temperature 72 +/-2 degrees F.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Test substance mixed with corn oil and homogeneity checked by sampling and radiocounting. Specific activity of formulated dose checked by sample combustion and scintillation counting.
- Duration and frequency of treatment / exposure:
- Single administration, following 18 hours of fasting..
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Stage 1: males 950 mg/kg, 4.5 microCuries 14C. Females 980 mg/kg, 3.3 microCuries 14C.
Stage 2: males 848 +/- 33.9 mg/kg, 4.08 +/- 0.35 microCuries 14C, 0.09 +/-0.07 microCuries 3H. Females 896.7 +/- 7.9 mg/kg, 2.9 +/- 0.08 microCuries 14C, 0.67 +/-0.07 microCuries 3H.
Stage 3: males 862.8 +/- 17.2 mg/kg, 4.1 +/- 0.07 microCuries 14C, 0.9 microCuries 3H. Females 902.8 +/- 30.3 mg/kg, 2.9 +/- 0.1 microCuries 14C, 0.63 +/-0.04 microCuries 3H.
- No. of animals per sex per dose / concentration:
- Stage 1 (CO2 collection): 1 male, 1 female.
Stage 2 (during faeces collection, tissue distribution): 4 males, 4 females but one female excluded from study (abnormal findings at necropsy - suggestive of maldosing).
Stage 3 (blood levels): 4 males, 4 females. - Control animals:
- no
- Positive control reference chemical:
- No
- Details on dosing and sampling:
- Stage 1: dosed rats placed in Roth metabolism chambers with scrubbed air supply (CO2, moisture removed). Expired air absorbed in ethanolamine/cellosolve trap, sampled 4, 12 and 24 hours post-dose.
Stage 2: dosed rats placed in open metabolism chambers (fed from 6 hours post-dose). Urine freeze-trapped, faeces collected separately: samples taken at 4,12,24,48,72,96,120,144 and 168 hours post-dose. After this 7 day period, rats anaesthetised and exsanguinated. Blood, brain, liver, kidneys, lung, muscle, skin, heart, testes, prostate, ovaries, uterus removed for radioanalysis.
Stage 3: dosed rats placed in restrainers for blood sampling at 0.25,0.5,1,2,3,4 and 6 hours post-dose, Then transferred to cages and fed. Restrained again for blood collection at 8,24,48,72,96,120,144 and 168 hours post-dose.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- results indicate very little absorption from GI tract
- Type:
- distribution
- Results:
- levels in tissues/organs generally low
- Type:
- excretion
- Results:
- most (85% or more) of administered radioactivity excreted in faeces
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- See tables: in all cases, a total of <5% of the administered 14C radioactivity was found in all examined tissues/organs plus the animal carcase. Residual 3H levels in tissues/organs were so low (close to twice background count) they could not be accurately quantified.
- Details on excretion:
- Stage 1: less than 0.55% of dosed radioactivity was expired in the form of 14CO2.
Stage 2: females excreted 1.85 +/-0.55% of dosed 14C in urine, 86.79 +/-3.08% in faeces.
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
Urinary and faecal excretion results (Stage 2 experiment).
Sex |
% dosed14C excreted |
% dosed3H excreted |
||||
In urine |
In faeces |
7-day total |
In urine |
In faeces |
7-day total |
|
Males |
3.29+/-0.8 |
85.16+/-1.11 |
92.18+/-0.59 |
5.04+/-0.88 |
98.40+/-1.34 |
103.44+/-1.39 |
Females |
1.85+/-0.55 |
86.79+/-3.08 |
91.6+/-2.5 |
4.06+/-1.04 |
100.86+/-3.21 |
104.92+/-2.19 |
Tissue distribution results (Stage 2 experiment).
Organ/tissue |
% of administered14C radioactivity recovered in sample |
||||||
Male 1 |
Male 2 |
Male 3 |
Male 4 |
Female 1 |
Female 2 |
Female 3 |
|
Brain |
0.015 |
0.012 |
0.016 |
0.016 |
0.023 |
0.024 |
0.021 |
Liver |
0.420 |
0.309 |
0.295 |
0.327 |
0.347 |
0.302 |
0.328 |
Kidney |
0.050 |
0.040 |
0.038 |
0.042 |
0.040 |
0.043 |
0.048 |
Heart |
0.015 |
0.013 |
0.012 |
0.013 |
0.015 |
0.014 |
0.012 |
Lung |
0.021 |
0.019 |
0.017 |
0.018 |
0.022 |
0.0224 |
0.025 |
Prostate |
0.007 |
0.008 |
0.012 |
0.013 |
- |
- |
- |
Testes |
0.032 |
0.023 |
0.021 |
0.028 |
- |
- |
- |
Ovaries |
- |
- |
- |
- |
0.002 |
0.002 |
0.001 |
Uterus |
- |
- |
- |
- |
0.005 |
0.006 |
0.003 |
Carcase |
2.794 |
2.765 |
4.551 |
3.096 |
2.502 |
2.426 |
2.647 |
Total |
3.354 |
3.189 |
4.962 |
3.553 |
2.956 |
2.841 |
3.085 |
Muscle, skin and blood values not reported.
In the Stage 3 experiment, recorded levels of radioactivity in the blood were low: mean peak blood radioactivity in both sexes was close to 3000 DPM/ml blood, occurring around 5.5 hours post-dosing in males, 5.25 hours post-dosing in females.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
The low levels of radioactivity recorded in tissues and blood samples and the high levels of radioactivity excretion in faeces suggest very little absorption from the gastrointestinal tract occurred following oral dosing. No potential for bioaccumulation was indicated by the study findings. Based on the close chemical similarity between gellan gum and Diutan, it is reasonable to predict that a comparable pattern of non-absorption would be seen if Diutan were to be similarly tested.
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