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EC number: 456-900-2 | CAS number: 51285-81-5 GADOLINIUMSULFIT-TRIHYDRAT
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 March 2003 - 22 April 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOiaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Standard Labaratory Conditions. Air-conditioned with target ranges for room temperature 22 ± 3 °C, relative humidity 30 - 70 % and 10 - 15 air changes per hour. Room temperature and humidity were monitared continuously and values outside of these ranges occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence an the study and, therefore, these data are not reported but are retained at RCC. There was a 12 hour fiuorescent light / 12 hour dark cycle with at least 8 hours music during the light period. In groups of four in Makroion type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). Pelleted standard Kliba 3433, batch no. 90/02 mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC. Community tap water from ltingen, available ad libitum. Results of representative bacteriological, chemical and contaminant analyses are archived at RCC.
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1 %, 2.5 %, 5 %
ln a non-GLP conform pre-test in two mice, test item concentrations of 1 %, 5 %, 10 % and 25 % (w/v) were tested an one ear each. No Irritation effects were observed at the dosing sites applied at concentrations of 1 % or 5 % (w/v). At the observation of 24 hours after the topical application, a slight swelling was noted at the local sites dosed at 10 % and 25 %. 5 % (w/v) was the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation. - No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 1 % test group
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 2.5 % test group
- Key result
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 5.0 % test group
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study STIMULATION INDICES of 1.0, 1.0 and 1.7 were determined with the test item at concentrations of 1 %, 2.5 % and 5 % (w/v) in acetone:olive oil, 4:1 (v/v). A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.I.). The test item Gadolinium sulfite trihydrate was found to be a non-sensitizer when tested at concentrations of up to 5 % (w/v). Gadolinium sulfite trihydrate showed a local Irritation when tested at concentrations of 2.5 % and 5 % (w/v).
- Executive summary:
In order to study a possible contact allergenic potential of Gadolinium sulfite trihydrate, three groups each of four female mice were treated daily with the test item at concentrations of 1 %, 2.5 % and 5 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (acetone:olive oil, 4:1 (v/v)) only. Five days alter the first topical application the mice were injected intravenously into a tail vein with radio-labellad thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a ß-scintillation counter.No test item-related clinical signs were observed in any animals of the control group or Group 2 (1 %). On the second application day, a slight to moderate swelling was observed at both dosing sites in all mice of Group 3 (2.5 %) and Group 4 (5 %), persisting for four to five days. All treated animals survived the scheduled study period. In this study STIMULATION INDICES of 1.0, 1.0 and 1.7 were determined with the test item at concentrations of 1 %, 2.5 % and 5 % (w/v) in acetone:olive oil, 4:1 (v/v). A test item is regarded as a sensitizer in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the STIMULATION INDEX (S.I.). The test item Gadolinium sulfite trihydrate was found to be a non-sensitizer when tested at concentrations of up to 5 % (w/v). Gadolinium sulfite trihydrate showed a local Irritation when tested at concentrations of 2.5 % and 5 % (w/v).
Reference
No test item-related clinical signs were observed in any animals of the control group or Group 2 (1 %). On the second application day, a slight tomoderate swelling was observed at both dosing sites in all mice of Group 3 (2.5 %) and Group 4 (5 %), persisting for four to five days. The body weight of the animals, recorded at the start of acclimatization period and prior to necropsy, was within the range commonly reoorded for animals of this strain and age.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
no adverse effect observed
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