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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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 method similar to that of relevant OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Exposure restricted to the period of organogenesis (gestation dates 6-15).
- GLP compliance:
- yes
- Limit test:
- no
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 (EC 275-117-5): blend of 5 production samples, mean polysaccharide content 58.5% .
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Adults housed separately in wire mesh bottomed, stainless steel cages (but paired for mating). Fed (powdered diet) and given access to water ad libitum. Animal room held at 21+/-3 degrees C, 50 +/-20% RH with 12 hour light, 12 hour dark cycle.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: test substance mixed in powdered diet
- Details on exposure:
- Test substance mixed with powdered diet in blender.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability and homogeneity of test substance in diet confirmed (pre-test) by results from another study using same substance and techniques. During the test period, samples taken and analysed to confirm concentration.
- Details on mating procedure:
- Females mated with one male of proven fertility; mating confirmed by presence of spermatozoa in vaginal lavage (designated gestation day 0).
- Duration of treatment / exposure:
- Days 6-15 of gestation.
- Frequency of treatment:
- Continuous daily exposure in food.
- Duration of test:
- Females terminated on gestation day 20.
- No. of animals per sex per dose:
- 25 females mated per group
- Control animals:
- yes, plain diet
- Details on study design:
- Females weighed on days 0,6,9,12,15,18,20 of gestation.
Examinations
- Maternal examinations:
- Daily observations and regular weighing. Detailed gross pathology examinations at necropsy.
- Ovaries and uterine content:
- Corporal lutea plus early, mid and late resorptions and live or deal foetuses scored. Implantation sites counted in non-pregnant rats (Salewski staining).
- Fetal examinations:
- All weighed and given detailed external examination (and sex recorded). Half of those in each litter given detailed internal examination then eviscerated and heads removed and placed in Bouin's fluid for later examination: bodies plus all other (eviscerated) foetuses transferred to alcohol for alizarin red staining and skeletal examination.
- Statistics:
- Maternal data: 1-way anovar then (if F significant) pairwise group comparisons using Student's t test.
Foetal data: Mann-Whitney U test (Student's t test for weights). - Indices:
- Pregnancy rate.
Pre- and post- implantation losses.
Incidences of foetal malformations and minor anomalies.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No evidence of maternal toxicity was seen. Minor gross pathology findings at termination were considered unrelated to treatment. Pregnancy rate was at least 88% in all groups.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The incidence of major malformations in test groups was no different from that among controls.
Subcutaneous oedema and accompanying skin changes in 7 foetuses from one litter made the occurrence of minor external/visceral anomalies significantly raised at 3.8%.
Cases of reduced ossification at 2.5% (mainly ribs) and 3.8% (mainly parietal bones) made group values significantly different from controls.
Common skeletal (sternebrae 1-4) variants were significantly increased at 3.8%.
None of the above minor anomalies/variants were seen in rats of the highest treatment group (5% in diet): it was concluded that they were not related to gellan gum exposure.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Based on reported female bodyweights and food intake figures, rats given 5% gellan gum in diet received approximately 3.9g gellan gum/kg bodyweight/day.
Applicant's summary and conclusion
- Conclusions:
- Exposure to gellan gum at up to 5% in diet (equivalent to an intake of approximately 3.9 g/kg/day) produced no evidence of maternal toxicity, no treatment-related embryo/foetal toxicity and no evidence of developmental toxicity. Based on the close similarity of chemical composition, it is reasonable to predict that Diutan would show a similar absence of reproductive and developmental toxicity.
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