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Diss Factsheets
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EC number: 201-321-0 | CAS number: 81-07-2
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Groups of mice (n=4) were exposed topically on the dorsum of both ears to 25 l of various concentrations of the test chemicals, or to the same volume of the relevant vehicle alone, daily for 3 consecutive days. Five days following initiation of exposure all mice were injected via the tail vein with 250 l of phosphate buffered saline (PBS) containing 20 Ci of [3H] methyl thymidine. Five hours later the mice were sacrificed and the draining auricular lymph nodes excised and pooled for each experimental group. Single cell suspensions of LNC were prepared by mechanical disaggregation through 200-mesh stainless steel gauze. Pooled LNC were washed twice with PBS and precipitated in 5% trichloroacetic acid (TCA) at 4°C overnight. Pellets were then resuspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase ‘Hisafe 3’, Wallac, Turku, Finland). The incorporation of 3H-TdR was measured by -scintillation counting as disintegrations per minute (dpm) per node for each experimental group. In each case a stimulation index (SI) relative to the concurrent vehicle-treated control was
derived; an SI of 3 or greater being indicative of a chemical possessing the potential to cause contact sensitization - GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Young adult (8–12 weeks old) CBA/Ca strain female mice (Harlan Seralab, Oxon, UK) were used throughout these studies. Animals were housed four per cage on flushing metal racks. Food (SDS PCD pelleted diet; Special Diets Services, Witham, Essex, UK) and water were available ad libitum.
- Route:
- intradermal and epicutaneous
- Vehicle:
- DMSO
- Concentration / amount:
- 0, 25, 50 and 75 %
- Concentration / amount:
- 0, 25, 50 and 75 %
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 25 µl
- No. of animals per dose:
- total: 16
0 %: 4 female
25 %: 4 female
50 %: 4 female
70 %: 4 female - Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 536 dpm/node to 803 dpm/node
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.
- Executive summary:
The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.
Reference
The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Weight of evidence summary for skin sensitization
In different studies, saccharin has been investigated for skin sensitizing effects. Often are the studies based on in vivo experiments in rodents, i.e. most commonly in mice or rats.
In a Mouse local lymphnode assay (LLNA) conducted by Warbrick et al (2001), Groups of mice (n=4) were exposed topically on the dorsum of both ears to 25 l of various concentrations of the test chemicals, or to the same volume of the relevant vehicle alone, daily for 3 consecutive days. Five days following initiation of exposure all mice were injected via the tail vein with 250 l of phosphate buffered saline (PBS) containing 20 Ci of [3H] methyl thymidine. Five hours later the mice were sacrificed and the draining auricular lymph nodes excised and pooled for each experimental group. Single cell suspensions of LNC were prepared by mechanical disaggregation through 200-mesh stainless steel gauze. Pooled LNC were washed twice with PBS and precipitated in 5% trichloroacetic acid (TCA) at 4°C overnight. Pellets were then resuspended in 1 ml of TCA and transferred to 10 ml of scintillation fluid (Optiphase ‘Hisafe 3’, Wallac, Turku, Finland). The incorporation of 3H-TdR was measured by -scintillation counting as disintegrations per minute (dpm) per node for each experimental group. In each case a stimulation index (SI) relative to the concurrent vehicle-treated control was derived; an SI of 3 or greater being indicative of a chemical possessing the potential to cause contact sensitization.
The maximal stimulation indices for saccharin were 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case. Thus based on this it can be concluded that saccharin does not induce the sensitization to skins of mice.
In another study by Patlewicz et al (2008) Saccharin is nonsensitizer by prediction generated from TIMES-SS/toolbox protein binding - nucleophilic heterocycle ring opening (acry transfer). Also from QSAR prediction it can be concluded that sodium saccharin is non sensitizing to skin.
Thus from all above studies it can be concluded that saccharin is not classified as the skin sensitizer as per the new CLP regulation.
Migrated from Short description of key information:
Saccharin was predicted as not being sensitizing to the skin of mouse.
Justification for selection of skin sensitisation endpoint:
The maximal stimulation indices for saccharin was 1.50, at a test concentration of 50%. Saccharin, which failed to stimulate a positive response at any concentration tested, EC3 values of 50 and > 75 %, respectively, were assigned, according to the maximum concentrations tested in each case.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
By applying weight of evidence approach , it can be concluded that the substance is non sensitizing to the skin of mouse. Thus the chemical is classified as non-sensitizing as per the criteria of new CLP regulation.
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