Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-983-7 | CAS number: 28348-53-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- other: Mouse micronucleus cytogenetic assay
Test material
- Reference substance name:
- Sodium cumenesulphonate
- EC Number:
- 248-983-7
- EC Name:
- Sodium cumenesulphonate
- Cas Number:
- 28348-53-0
- Molecular formula:
- C9H12O3S.Na
- IUPAC Name:
- sodium cumenesulphonate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 99.4%
Remarks: 40% solution in water
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Details on species / strain selection:
- Species: Mouse , 24-30 g.
Strain: NMRI
Sex: Male/female
No. of animals 5 per sex per dose group per sample time - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Strain NMRI. Animals were approximately 24-30 g and acclimated for 1 week to the test conditions (20 =/- 3 degrees C, 30-70% relative humidity, 12 hour light/dark cycle).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: 40 %
- Amount of vehicle: 16.8 ml/kg bw - Details on exposure:
- Single oral dose at 0 and 4467 mg/kg bw; vehicle water, dose volume 17 ml/kg bw. Dose selection was based on preliminary studies with 2-5/sex: no
deaths at and below 4467 mg/kg bw ( one incidental death (female) at 3981 mg/kg bw), 4/10 deaths at 5000 mg/kg bw. - Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- single oral application
- Post exposure period:
- 24, 48 and 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4467 mg/kg bw
Basis: actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: oral by gavage
- Dose: 100 mg/kg bw
- Vehicle: water
- Total application volume: 10 ml/kg bw
- post exposure period: 24 hours
Examinations
- Tissues and cell types examined:
- bone marrow; polychromatic erythrocytes (PCE), normochromatic erythrocytes (NCE)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The maximum tolerable dose (MTD)* was selected as dose.
The MTD was determined in a dose range finding study :
Phase 1: Limit test with 5000 mg/kg bw
Phase 2: Determination of the TMTD range with reduced animal number
Phase 3: Determination of the MTD with 5 animals/sex/dose
*MTD is defined as dose with no mortality but clear clinical symptoms within 3 days after application
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
24, 48 and 72 hours after treatment the animals were killed by cervical dislocation and tissue was sampled.
DETAILS OF SLIDE PREPARATION:
The femora were removed and the bone marrow was suspended in fetal calf serum. The cell suspensions were centrifuged with 160 x g for 5 minutes and the supernatand discarded. The serum was resuspended and the suspension purified using a cellulose chromatographic column. The eluate was centrifuged at 800 x g for 10 minutes and the pellet in fetal calf serum /25 mM EDTA suspended. From this suspension 3-4 smears per animals were prepared on slides which were dried for at least 24 hours and stained with May-Grünwald/Giemsa solution.
METHOD OF ANALYSIS:
The cell analysis was performed by means of a Zeiss miscroscope at a 1000fold magnification (oil immersion). At least 1000 polychromatic erythrocytes (PCE) per animal were examined to determine the frequency of micronucleated cells. The ratio of PCE to normochromatic cells (NCO) was determined for a sample of 1000 erythrocytes. The number of micronucleated cells in counted NCE was determined. - Evaluation criteria:
- For the identification of micronuclei the following criteria were considered:
a) roundish and clear contour by the nuclear membrane
b) diameter of about 1/20 of the size of the polychromatic erythrocyte
c) lays in the same focus layer as the observed erythrocyte
The micronucleus test is regarded as positive (test substance induces micronuclei in polychromatic erythrocytes) if the frequency of mucronucleated polychromatic erythrocytes of at least one tretament group is statistically significantly increased compared to the negative control and the increase is biologically relevant. - Statistics:
- Mean values and standard deviations were calculated for the following parameters:
a) number of polychromatic erythrocytes (PCE) containing micronuclei
b) ratio of PCE/NCE
Comparison of treatment groups with different post exposure periods with negative controls of respective post exposure periods. After control of the relative frequency of micronuclei in the treatment groups on homogeneity with the mean relative frequency a statistical analysis of micronucleus frequency using a 2 x 2 contingency table with chi² test and continuity table according to Yates was performed (see [1]).
The differences of miconucleus frequencies in the positive control were reassessed in the two-sided t-test. This test was also used for the statistical analysis of the PCE/NCE-ratio.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Sodium cumenesulphonate under these test conditions is regarded as not mutagenic in the micronucleus test.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results : negative
All male mice treated with the test substance showed no statistically significant increase in micronucleus frequency at any sampling time compared to control animals. For the female mice treated with the test substance at sampling times 24 and 48 hours after treatment also no statistically significant increase in micronucleus frequency was observed. Only at sampling time point 72 hours a statistically significant increase of polychromatic erythrocytes with micronuclei compared to control animals was observed. This effect was regarded as biologically not relevant as this increase ís based on the exceptional low micronucleus frequency of vehicle control group.
Sodium cumenesulphonate under these test conditions is regarded as not mutagenic in the micronucleus test. - Executive summary:
Interpretation of results : negative
All male mice treated with the test substance showed no statistically significant increase in micronucleus frequency at any sampling time compared to control animals. For the female mice treated with the test substance at sampling times 24 and 48 hours after treatment also no statistically significant increase in micronucleus frequency was observed. Only at sampling time point 72 hours a statistically significant increase of polychromatic erythrocytes with micronuclei compared to control animals was observed. This effect was regarded as biologically not relevant as this increase ís based on the exceptional low micronucleus frequency of vehicle control group.
Sodium cumenesulphonate under these test conditions is regarded as not mutagenic in the micronucleus test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.