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EC number: 213-180-2 | CAS number: 928-70-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 14 - December 4, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the OECD 429 guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Potassium isopentyl dithiocarbonate
- IUPAC Name:
- Potassium isopentyl dithiocarbonate
- Reference substance name:
- Potassium isopentyl dithiocarbonate
- EC Number:
- 213-180-2
- EC Name:
- Potassium isopentyl dithiocarbonate
- Cas Number:
- 928-70-1
- Molecular formula:
- C6H11KOS2
- IUPAC Name:
- potassium {[(3-methylbutyl)sulfanyl]carbonyl}sulfanide
- Test material form:
- solid: pellets
- Details on test material:
- Physical state: solid
- Analytical purity: 90.2 %
- Lot/batch No.: 2012-06
- Expiration date of the lot/batch: 1.1.2013
- Storage condition of test material: at ambient temperature
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan laboratories srl, Italy
- Age at study initiation: 8-12 weeks old
- Diet (e.g. ad libitum): Certified laboratory food (MP-OS-06)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Potassium isoamyl xanthate was tested at five concentrations (2.5 %, 5 %, 10 %, 25 % and 50 %)
- No. of animals per dose:
- 5 animals / dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility:
- Irritation: no observed irritation
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- The animals were weighed and allocated to the test group based on their actual body weight. Each group was approximately equal initial body weight.
- The test item in the appropriate dilution (25ul) was applied to the dorsum of each ear on day 1, 2 and 3.
- On day 6 a volume of 250 ul of phophate-buffered saline (PBS) containing 20uCi of 3H-methyl thymidine was injected into all test and control mice via the tail vein.
- Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group.
- Cell suspenson of lymph node cells were prepared and counted for 3H-methyl thymidine radioactivity.
- Criteria used to consider a positive response: Results are expressed as the Stimulation Index (SI). The SI is obtained by dividing the pooled radioactive incorporation for each treatment group by the incorporation of the pooled vehicle control group; this yield a mean SI. The concentration eliciting a SI of 3 is edientified as the EC3 value and was calculated by linar interpolation of points on the dose-response curve, immediately above and below the threefold threshold with the co-ordinates (a,b) and (c,d), respectively according to the equation: EC3=c+[(3-d)/(b-d)] * (a-c).
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 2.5 % 1.57 5 % 2.21 10% 2.94 25% 4.12 50% 4.59
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 2.5 % 749.33 5 % 1053.69 10% 1402.08 25% 1966.09 50% 2189.85
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The skin sensitising potential of potassium isoamyl xanthate was assessed using murine local lymph node assay. Based on the results and SI values the substance in LLNA was evaluated as a sensitiser.
- Executive summary:
This study was regarded reliable without restrictions since the the study was conducted according to the OECD 429 guideline and in compliance with GLP.
Potassium isoamyl xanthate was applied over three consecutive days at five concentrations. Lymph node weights were measured and DPM values were calculated in all treated groups. The changes were dose dependent. The SI values over 3 were determined at concentrations 25 and 50 %. In general, when the SI for any single treatment dose group is ≥ 3, the test item is regarded as a potential skin sensitiser. According to the EC3 value (10.77 %) calculated for potassium isoamyl xanthate, the substance should be classified as skin sensitiser according to CLP Regulation 1272/2008.
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