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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- 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 a close chemical analogue, performed in general accordance with the relevant OECD test guideline (deviations insufficient to affect reproductive performance assessment).
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 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- Gross pathology examinations only at necropsy (except for malformed pups, those born dead and those dying before day 7). No histopathology examinations or organ weights.
- GLP compliance:
- yes
- Remarks:
- GLP Compliance statement included
- 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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Individually housed in stainless steel, wire mesh-bottomed cages except during mating (paired) or littering females (clear plastic cages). Free access to tapwater, fed powdered diet. Maintained at 21 +/- 3 degrees C, RH 50 +/- 20% (target values: minor excursions from targets only) and with photoperiod 12 hours light/12 hours dark.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: test substance mixed with basal diet
- Details on exposure:
- Test diets prepared weekly by mixing test substance and basal diet in blender.
- Details on mating procedure:
- Each female paired with one male for maximum 7 days, with daily checking for sperm in vaginal lavage. If unmated, given up to two more 7-day pairings with unmated males from the same group.
- 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. During test period, samples taken for analysis in weeks 1,4,8,12,16,22,27,31,36.
- Duration of treatment / exposure:
- P generation males fed test diet for 70 days prior to mating, through mating and for at least 3 more weeks until termination. P females treated for 14 days pre-mating then through mating, gestation and lactation.
F1 generation treated from weaning (day 21 post-partum) for at least 80 days prior to mating then (females) through gestation, parturition and lactation.
F2 generation terminated at weaning (no direct treatment). - Frequency of treatment:
- Continuous via consumption of test diet
- Details on study schedule:
- F1 pups separated from mothers on day 21 post-partum: 2 males, 2 females/litter randomly selected and housed separately until end of weaning, then 26 males + 26 females/group randomly selected for mating. These F1 rats treated for 80-97 days in all prior to mating (then through to termination).
F2 pups terminated after weaning (day 21 post-partum).
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2.5%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
3.8%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
5%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 26 males + 26 females (P and F1)
- Control animals:
- yes, plain diet
- Positive control:
- No
Examinations
- Parental animals: Observations and examinations:
- Daily observations, weekly detailed examinations plus 3 times daily checks for parturition.
- Oestrous cyclicity (parental animals):
- Daily examination of vaginal lavage.
- Sperm parameters (parental animals):
- Observation of sperm in vaginal lavage gave day 0 of gestation.
- Litter observations:
- Live and dead pups recorded at completion of littering. Malformed pups terminated: these plus stillbirths preserved for internal examination, together with all culled pups (litters reduced to 5 males, 5 females where possible).
Daily observations.
Bodyweights recorded on days 0,7,14 and 21 post-partum. - Postmortem examinations (parental animals):
- Gross examinations (internal and external) at necropsy.
Uterine implantation sites recorded. - Postmortem examinations (offspring):
- Detailed internal examination (including eyes, brain and other organs) for pups malformed, born dead or dying before day 7 post-partum.
Gross examinations at necropsy (10 males, 10 females/group selected 21-23 days post-partum). - Statistics:
- Student's t-test (bodyweights and food intakes).
Kruskal-Wallis, Mann-Whitney U tests (days of mating, post-implantation loss, litter data).
Fisher's exact test or chi-square test (reproductive indices, gestation index). - Reproductive indices:
- Mating index (% of paired females which mated)
Fertility index (% of paired females found pregnant)
Conception rate (% of females confirmed mated found pregnant). - Offspring viability indices:
- Gestation index (% of pregnant rats giving birth to live pups).
Post-implantation loss (implantation sites - live births/implantation sites x 100)
Viability index (% of day 0 live pups surviving to day 4)
Lactation index (% of day 4 live pups surviving to day 21).
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance intake: Achieved intake decreased over 10 treatment weeks. At 5% in diet intake g/kg/day was: P 6.0-3.0(M) 4.2-4.1(F), F1 6.5-2.8(M) 6.7-3.5 (F).
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No evidence of parental toxicity and no effect on reproductive performance seen at highest treatment level (5%)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No evidence of toxicity, no effect on reproductive performance and no effect on development of F1 rats seen at the highest treatment level (5%)
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOEL
- Generation:
- F2
- Effect level:
- 5 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on F2 development seen at the highest treatment level (5%)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Administration of gellan gum to P and F1 rats at levels up to 5% in diet resulted in achieved adult intakes within the range 2.8-6.5 g/kg (males), 3.0-4.2 g/kg (females). No evidence of toxicity or adverse effects on reproductive performance or development was seen. Given the close similarity between gellan gum and Diutan, it is reasonable to predict that Diutan would show a similar lack of toxicity to reproduction.
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