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Diss Factsheets
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EC number: 202-638-7 | CAS number: 98-11-3
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Remarks:
- Type of genotoxicity: bone marrow chromosome aberration
- Type of information:
- other: Read across from a member of the Hydrotropes category
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5385 (In Vivo Mammalian Cytogenetic Tests: Bone Marrow Chromosomal Analysis)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian bone marrow chromosome aberration test
Test material
- Reference substance name:
- Calcium xylenesulphonate
- EC Number:
- 248-829-9
- EC Name:
- Calcium xylenesulphonate
- IUPAC Name:
- calcium xylenesulphonate
Constituent 1
Results and discussion
Test resultsopen allclose all
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Pilot study
Mortality occurred within two hours of dose administration in 5/5 males and 5/5 females at 5000 mg/kg and within one day of dose administration in 2/2 males at 1000 mg/kg. Clinical signs, which were noted on the day of dosing with 1000 mg/kg, included lethargy. All other surviving animals appeared normal throughout the observation period.
Toxicity study
Mortality occurred within two days of dose administration as follows: 5/5 males and 5/5 females at 1000 mg/kg and 3/5 males and 0/5 females at 700 mg/kg. Clinical signs included: lethargy in male and female mice at 500, 700, and 1000 mg/kg. One male mouse treated with 200 mg/kg also exhibited lethargy. In the male mouse group treated with 700 mg/kg, one mouse exhibited piloerection and another mouse, that eventually died, was prostrate with irregular breathing. All other animals appeared normal throughout the observation period. The LD50/3 was calculated by probit analysis to be approximately 723 mg/kg. The high dose for the micronucleus test was set at 580 mg/kg which was estimated to be approximately 80% of the LD5O/3.
Micronucleous test
No mortality was observed in any male or female mice in the micronucleus study. Clinical signs following dose administration included lethargy in male and female mice at 580 mg/kg
A 36% reduction in the ratio of polychromatic erythrocytes to total erythrocytes was observed in male mice sacrificed at 72 hours with 580 mg/kg relative to their respective vehicle controls. The presence of lethargy and reduction in the frequency of polychromatic erythrocytes in the bone marrow demonstrate that suitable dose levels were used. No significant increases in micronucleated polychromatic erythrocytes were observed in either sex at any time period relative to their respective vehicle controls. The positive control induced a significant increase in micronucleated polychromatic erythrocytes in both sexes. The vehicle (negative) and positive controls fulfilled the requirements for determination of a valid test.
Any other information on results incl. tables
See attached tables.
Applicant's summary and conclusion
- Conclusions:
- Not genotoxic
- Executive summary:
The potential of Sodium p-cumenesulphonate to cause cytogenetic damage which results in the formation of micronuclei containing lagging chromosome fragments or whole chromosomes was assessed following official guideline OECD 474, Mammalian Erythrocyte Micronucleus Test. No significant increases in micronucleated polychromatic erythrocytes were observed in male or female ICR mice at 24, 48 or 72 hours after dose administration relative to their respective vehicle controls. The results of the assay indicate that under the conditions described in this report, Calcium xylene sulphonate did not induce a significant increase in micronucleated polychromatic erythrocytes in either male or female ICR mice.
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