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EC number: 239-854-6 | CAS number: 15763-76-5
- 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
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Carcinogenicity
Administrative data
Description of key information
The HYDROTOPES Category comprises the following 6 substances:
STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)
SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)
NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)
SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)
KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)
NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)
In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH.
There are two key studies for the hydrotrope category substances, both conducted on Sodium (xylenes and 4-ethylbenzene) sulfonates. The key studies are 2-year rat and mouse dermal exposure studies conducted under GLP. Up to 240 mg (rats) and 727 mg (mice)/kg body weight in 50% ethanol were dosed 5 days per week for 104 weeks. There were no treatment related incidences of mononuclear cell leukaemia, neoplasms, or non-neoplastic lesions of the skin and other organs. The increased incidence of epidermal hyperplasia may have been related to exposure to the test substance. The NOAEL for systemic toxicity and carcinogenicity was reported as 240 mg/kg bw/day for rats and 727 mg/kg bw/day for mice. The NOAEL for local effects is considered to be 60 mg/kg bw/day, based on the findings from the rat study.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- other: Read across from another member of the category
- Adequacy of study:
- key study
- Study period:
- December 20, 1990 to December 18, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Protocols and results reviewed and accepted by the National Toxicology Program's Board of Scientific Counselor's Reports Review Subcommittee. USA National Institutes of Health
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Inc (Gilroy, CA)
- Age at study initiation: 7 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: individually caged in polycarbonate cages changed once per week and rotated on stainless steel racks once every two weeks. Sani-chip hardwood chips and spun-bonded polyester cage filters.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.7 to 25.6 °C
- Humidity (%): 34 to 69 %
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: December 20, 1990 To: December 18, 1992 - Route of administration:
- dermal
- Vehicle:
- ethanol
- Remarks:
- use of ethanol increase the probability of skin penetration
- Details on exposure:
- TEST SITE
- Area of exposure: shaved interscapular skin
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 46 to 128 microliters
- Concentration (if solution): 50% of applied volume. Doses were 0, 182, 364 and 727 mg/kg bw
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): test material beads up in distilled water
- Amount(s) applied (volume or weight with unit): in the 46 to 128 microliters
- Concentration (if solution): 50%
- Lot/batch no. (if required): no data
- Purity: no data
USE OF RESTRAINERS FOR PREVENTING INGESTION: no data - Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 5 days per week
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- males and females, Based on analytical conc.
- Dose / conc.:
- 108 mg/kg bw/day (nominal)
- Remarks:
- equivalent to 100 mg/kg/day a.i.
- Dose / conc.:
- 323 mg/kg bw/day (nominal)
- Remarks:
- equivalent to 300 mg/kg/day a.i.
- Dose / conc.:
- 1 076 mg/kg bw/day (nominal)
- Remarks:
- equivalent to 1000 mg/kg/day a.i.
- No. of animals per sex per dose:
- 50
- Statistics:
- Kaplan-Meier, logistic regression analysis, life table test, FIsher exact test, Cochran-Armitage trend test, comparison of continuous variables, Dunnett and Williams test, Shirley and Dunn
- Conclusions:
- Not carcinogenic in mice
- Executive summary:
The potential of Sodium (xylenes and 4-ethylbenzene) sulfonates to cause carcinogenic and chronic effects and to determine dose-response relationships following prolonged and repeated exposure on mice was assessed following official guideline OECD 453, Combined Chronic Toxicity/Carcinogenicity Studies. Under the conditions of these 2-year dermal studies, there was no evidence of carcinogenic activity of Sodium (xylenes and 4-ethylbenzene) sulfonates in male or female B6C3F1 mice administered with 182, 364, or 727 mg/kg bw. Increased incidences of epidermal hyperplasia in male mice may have been related to exposure to Sodium (xylenes and 4-ethylbenzene) sulfonates.
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- other: Read across from another member of the category
- Adequacy of study:
- key study
- Study period:
- November 29, 1990 to November 20, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Protocols and results reviewed and accepted by the National Toxicology Program's board of Scientific Counselor's Technical Reports Review Subcommittee, USA National Institutes of Health
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Simonsen Laboratories, Inc (Gilroy, CA)
- Age at study initiation: 7 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: housed individually in polycarbonate cages; changed every week and stainless steel racks rotated every 2 weeks. Heat-treated hardwood chips and spun-bonded polyester cage filters
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24.4
- Humidity (%): 35-70
- Air changes (per hr): 10 per day minimum
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: November 29, 1990 To: November 20, 1992 - Route of administration:
- dermal
- Vehicle:
- ethanol
- Remarks:
- use of ethanol increase the probability of skin penetration
- Details on exposure:
- TEST SITE
- Area of exposure: shaved interscapular skin
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 85 to 357 microliters (volume adjusted for weights during the study)
- Concentration (if solution): 50% of applied volume; doses were 0, 60, 120 and 240 mg/kg bw
- Constant volume or concentration used: yes
VEHICLE- Justification for use and choice of vehicle (if other than water): beading of test substance in ethanol
- Amount(s) applied (volume or weight with unit): as part of the 85-357 microliters
- Concentration (if solution): 50%
- Lot/batch no. (if required): no data
- Purity: no data
USE OF RESTRAINERS FOR PREVENTING INGESTION: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC at the beginning of the study and then every 7 to 10 weeks
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 5 days per week
- Post exposure period:
- no data
- Remarks:
- Doses / Concentrations:0, 60, 120 and 240 mg/kg bwBasis:analytical conc.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: based on 17 day and 14 week range finding studies
- Rationale for animal assignment: random
50 male and 50 female F344/N rats (at 6 weeks old) were administered dermal applications of 0, 60, 120 or 240 mg sodium xylenefulfonate/kg body weight in 50% ethanol.
Doses were applied 5 days per week for 104 weeks to the clipped interscapular skin at volumes of 85 to 357 microliters.
Volumes were adjusted for the weights of the animals throughout the study. Animals were housed individually and fed and given water ad libitum. Cages were changed weekly and racks were rotated every 2 weeks. All animals were observed twice daily and clinical findings were recorded monthly. Body weights were recorded weekly for 13 weeks, then monthly thereafter. All animals were necropsied and a complete histopathological examination was performed. All organs and tissues including skin were examined for grossly visible lesions. Major tissues were examined microscopically and slides were evaluated by an independent quality laboratory in addition to the study laboratory pathologist. - Positive control:
- no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations checked in table were not included.
DETAILED CLINICAL OBSERVATIONS:
Yes- Time schedule: monthly
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: monthly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly through week 13, monthly thereafter
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not a drinking water study
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Complete histopathologic examinations were performed on all control, on all 240 mg/kg rats, and on all animals that died early.
In these animals, in addition to gross lesions, tissue masses, and associated lymph nodes, the tissues examined included: adrenal gland, bone and marrow, brain, clitoral gland, esophagus, gallbladder (mice), heart, kidney, large intestine (cecum, colon and rectum), small intestine (duodenum, jejunum, and ileum), liver, lung, lymph nodes (mandibular and mesenteric), mammary gland, nose, ovary, pancreas, parathyroid gland, pituitary gland, preputial gland, prostate gland, salivary gland, spleen, stomach (forestomach and glandular stomach), testis with epididymis and seminal vesicle, thymus, thyroid gland, trachea, urinary bladder, and uterus. In 60 and 120 mg/kg rats tissues examined microscopically included skin from the site of application and control skin. Additional review was made of the liver and spleen of 60 and 120 mg/kg male rats for mononuclear cell leukemia; the clitoral gland of female rats and the preputial gland of control and high-dose male rats for proliferative lesions. - Statistics:
- Kaplan-Meier, logistic regression analysis, life table test, FIsher exact test, Cochran-Armitage trend test, comparison of continuous variables, Dunnett and Williams test, Shirley and Dunn
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Survival of dosed males and females was similar to that of the control groups. Mean body weights of dosed males and females were similar to those of the controls throughout the study. In male groups, there were no clinical findings considered treatment related. In females, clinical findings were limited to irritation at the site of application in one control female, four 120 mg/kg females, and two 240 mg/kg females.
There were no neoplasms at any site (including the skin) that were considered treatment related. Low incidences of hyperplasia of the epidermis at the site of application occurred in males in the 60, 120, and 240 mg/kg groups. Low incidences of hyperplasia of the epidermis at the site of application also occurred in females in the 120 and 240 mg/kg groups, and they occurred with a significant positive trend. Low incidences of hyperplasia of the sebaceous gland occurred in control and 60 mg/kg males and in control, 120 mg/kg, and 240 mg/kg females. - Relevance of carcinogenic effects / potential:
- No evidence of carcinogenic activity.
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- carcinogenicity
- Effect level:
- >= 240 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: overall effectsclinical signs; mortality; body weight; gross pathology; organ weights; histopathology
- Dose descriptor:
- NOAEL
- Remarks:
- local effects on skin
- Effect level:
- >= 60 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: Epidermal hyperplasia
- Conclusions:
- Test substance was found to be non-carcinogenic in rats
- Executive summary:
The potential of Sodium (xylenes and 4-ethylbenzene) sulfonates to cause carcinogenic and chronic effects and to determine dose-response relationships following prolonged and repeated exposure on mouse was assessed following official guideline OECD 453, Combined Chronic Toxicity/Carcinogenicity Studies. Under the conditions of these 2-year dermal studies, there was no evidence of carcinogenic activity of Sodium (xylenes and 4-ethylbenzene) sulfonates in male or female F344/N rats administered 60, 120, or 240 mg/kg bw.
Increased incidences of epidermal hyperplasia in female rats may have been related to exposure to sodium xylenesulfonate.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 240 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Sufficient to meet requirements.
Justification for classification or non-classification
There was no evidence of carcinogenic activity in two dermal carcinogenicity studies in rats and mice. Therefore there is no justification for hazard classification.
Additional information
50 male and 50 female rats and mice were administered dermal applications of up to 240 mg (rats) and 727 mg (mice) sodium xylenefulfonate/kg body weight in 50% ethanol. Doses were applied 5 days per week for 104 weeks to the clipped interscapular skin at volumes adjusted for the weights of the animals throughout the study. Animals were housed individually and fed and given water ad libitum. Cages were changed weekly and racks were rotated every 2 weeks. All animals were observed twice daily and clinical findings were recorded monthly. Body weights were recorded weekly for 13 weeks, then monthly thereafter. All animals were necropsied and a complete histopathological examination was performed. All organs and tissues including skin were examined for grossly visible lesions. Major tissues were examined microscopically and slides were evaluated by an independent quality laboratory in addition to the study laboratory pathologist. The study was conducted under GLPs from late 1990 to late 1992 at the Battelle Columbus Laboratories. NTP Technical Report on the Toxicology and Carcinogenesis Studies of Technical Grade Sodium Xylenesulfonate in F344/N Rats and B6C3F1 Mice. NTP TR 464, June 1998. The study reliability is Klimisch 1.
Survival of the dosed males and females was similar to that of the control groups and consistent with historical controls.
Mean body weights of dosed males and females were similar to those of the controls throughout and there were no clinical findings considered treatment related in males. In female rats, clinical findings were limited to irritation at the site of application in one control, in 4 at 120 mg/kg bw and in 2 at 240 mg/kg bw. In mice, clinical finding were limited to irritation of the site of application in female controls, and males and females at the 364 and 727 mg/kg bw doses. There were no treatment related incidences of mononuclear cell leukaemia, neoplasms, or non-neoplastic lesions of the skin and other organs. The increased incidence of epidermal hyperplasia may have been related to exposure to the test substance.
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.
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