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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
Endpoint summary
Administrative data
Description of key information
Oral repeated dose toxicity
20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively. Endpoints were mortality, body and organ weight, food consumption, haematology, and histopathology. No treatment related effects were observed in males at up to the highest dose (114 mg a.i./kg bw). The only effect observed was an 11.7% decrease in body weight gain in females at the highest dose (159 mg a.i./kg bw). The study report stated that this decrease in body weight gain was within the established ranges for animals of this species and age and was therefore not considered an adverse effect by the authors. The feed efficiency of the high dose females was statistically higher than the controls. The decrease in body weight gain of the high dose females was not associated with any histopathologic or other effects. In light of the palatability issues seen in the previously discussed study, this slight decrease in body weight gain may be explained as a palatability effect Also, the intervals between the dose levels in this study are large (factor of 10), while OECD 408 prefers 2-4 fold intervals and prefers an additional group if the factors are > 6-10.
A NOAEL for sodium cumene sulfonate is therefore >114 mg a.i./kg bw for males and >159 mg a.i./kg bw in femalesif the slight decrease in body weight gain is not considered toxicologically significant.
Dermal repeated dose toxicity
The NOAEL was 800 mg/kg bw per day, on the basis of epidermal hyperplasia.
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) /
Treated surface in cm2) NOAELtest* 0.25/44.5= NOAELmodified The highest dose not causing irritation/corrosion was 800 mg/kg bw in dermal toxicity study in rats
The modified dose descriptor would be:
NOAELmodified=800 mg/kg*0.25 kg/44.5cm2=4.49mg/cm2
Inhalation repeated dose toxicity
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
114 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat 4.96 mg/m3
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- 20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively. Endpoints were mortality, body and organ weight, food consumption, haematology, and histopathology.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- Test Substance
CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 42.3%
Remarks: Substances tested are aqueous solutions; % purity equates to chemical content - Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- 20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-CD rats
- Age at study initiation: newly weaned
- Weight at study initiation: 41-60 g
- Fasting period before study: no data
- Housing: metal wire screen cages (5 to a cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 degrees centigrade
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- 20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively. Endpoints were mortality, body and organ weight, food consumption, haematology, and histopathology.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- in ad libitum diet
- Remarks:
- Doses / Concentrations:
0, 0.005, 0.05 and 0.5 % in diet - No. of animals per sex per dose:
- 20 per sex per dose group
- Control animals:
- yes
- Details on study design:
- 20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively.
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Observations: general appearance and behaviour
- Time schedule: no data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
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: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
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: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly for the first week only
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 6 and week 12
- Anaesthetic used for blood collection: No data
- Animals fasted: No
- How many animals: 10 males and 10 females from each dose group
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: terminally
- Animals fasted: No data
- How many animals: 10 males and 10 females from each dose group
URINALYSIS: Yes
- Time schedule for collection of urine: urinalysis from pooled samples from 10 males and 10 females from each dose group in 7th week.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: kidney funcion from samples of 10 males and 10 females in 13th week. Serum protein electrophoresis of 10 males and 10 females of control and high dose groups at 13 weeks. Liver enzyme activity at termination. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - 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):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- 20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively. Endpoints were mortality, body and organ weight, food consumption, haematology, and histopathology. No treatment related effects were observed in males at up to the highest dose (114 mg a.i./kg bw). The only effect observed was an 11.7% decrease in body weight gain in females at the highest dose (159 mg a.i./kg bw). The study report stated that this decrease in body weight gain was within the established ranges for animals of this species and age and was therefore not considered an adverse effect by the authors. The feed efficiency of the high dose females was statistically higher than the controls. The decrease in body weight gain of the high dose females was not associated with any histopathologic or other effects. In light of the palatability issues seen in the previously discussed study, this slight decrease in body weight gain may be explained as a palatability effect Also, the intervals between the dose levels in this study are large (factor of 10), while OECD 408 prefers 2-4 fold intervals and prefers an additional group if the factors are > 6-10. A NOAEL for sodium cumene sulfonate is therefore >114 mg a.i./kg bw for males and >159 mg a.i./kg bw in females if the slight decrease in body weight gain is not considered toxicologically significant.
- Dose descriptor:
- NOAEL
- Effect level:
- > 114 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- Dose descriptor:
- NOAEL
- Effect level:
- > 159 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- Critical effects observed:
- not specified
- Conclusions:
- A NOAEL for sodium cumene sulfonate is >114 mg a.i./kg bw for males and >159 mg a.i./kg bw in females if the slight decrease in body weight gain is not considered toxicologically significant.
- Executive summary:
20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively. Endpoints were mortality, body and organ weight, food consumption, haematology, and histopathology. No treatment related effects were observed in males at up to the highest dose (114 mg a.i./kg bw). The only effect observed was an 11.7% decrease in body weight gain in females at the highest dose (159 mg a.i./kg bw). The study report stated that this decrease in body weight gain was within the established ranges for animals of this species and age and was therefore not considered an adverse effect by the authors. The feed efficiency of the high dose females was statistically higher than the controls. The decrease in body weight gain of the high dose females was not associated with any histopathologic or other effects. In light of the palatability issues seen in the previously discussed study, this slight decrease in body weight gain may be explained as a palatability effect Also, the intervals between the dose levels in this study are large (factor of 10), while OECD 408 prefers 2-4 fold intervals and prefers an additional group if the factors are > 6-10. A NOAEL for sodium cumene sulfonate is therefore >114 mg a.i./kg bw for males and >159 mg a.i./kg bw in females if the slight decrease in body weight gain is not considered toxicologically significant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 114 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- A NOAEL for sodium cumene sulfonate is >114 mg a.i./kg bw for males and >159 mg a.i./kg bw in females if the slight decrease in body weight gain is not considered toxicologically significant.
Sufficient to meet requirements
In the (Q)SAR study, NOAEL for Repeated dose oral toxicity was 385 mg/kg bw/day (No adverse effects on the highest dose tested) for S-allyl O-pentyl dithiocarbonate. This HESS QSAR grouping method contains simple categories for Repeated dose oral toxicity.This method is relevant for Repeated dose oral toxicity endpoints in mammals. The database include a set of 75 chemicals that have been evaluated for their repeated dose oral toxicity potential.
NOAEL= 385 mg/kg bw/day - System:
- other: slight decrease in body weight gain
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 4.96 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Inhalation exposure:
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
114 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat 4.96 mg/m3
NOAEC of 4.96 mg/m3 was established based on no effects in rats.
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 4.96 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Inhalation exposure:
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat
114 mg/kg bw/day
÷1.15 m3/kgbw
÷20m3/rat
NOAECrat 4.96 mg/m3
NOAEC of 4.96 mg/m3 was established based on no effects in rats.
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- As per OECD 411 with the exception of clinical signs recorded weekly, no food consumption, no ophthalmoscopy, clinical
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- CAS Number: 1300-72-7
Identity: Xylene sulfonic acid, sodium salt
Purity: 65%
Remarks: purity 65% (11.5% ortho, 38% meta and 15.5% para). - Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: 6 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 1 animal per cage; polycarbonate cage with stainless steel rack (rotated every 2 weeks); heat-treated hardwood chips and spun-bonded polyester cage filters changed weekly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 24.5
- Humidity (%): 20 to 67
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Vehicle:
- ethanol
- Details on exposure:
- TEST SITE
- Area of exposure: clipped interscapular skin
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: once at start of study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 microliters
- Concentration (if solution): 0, 5, 15, 44, 133, 400 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): ethanol because test material beads up rather than spreads out when applied neat
- Amount(s) applied (volume or weight with unit): 300 microliters of combined test material and vehicle
- Concentration (if solution): 50% solution of ethanol i water
- Lot/batch no. (if required): no data
- Purity: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC on each dose at beginning, middle and end of the study
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days per week
- Remarks:
- Doses / Concentrations:
5, 15, 44, 133 and 400 mg/ml (vehicle 50% ethanol, volume applied 0.3 ml) which averaged approximately 6, 20, 60, 170 and 500 mg a.i./kg for males and
10, 30, 90, 260 and 800 mg a.i./kg for females taking into consideration the 65% purity of the substance; solutions/suspensions were prepared every 2
weeks; feeding ad libitum. - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Dose selection rationale: wide range of doses for screening
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: 10 males and 10 females at each dose for special hematology and clinical chemistry study
- Post-exposure recovery period in satellite groups: no data
- Section schedule rationale (if not random): random - 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: weekly
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 5 and 21 (from satellite group) and at end of study for all animals
- Anaesthetic used for blood collection: Yes / carbon dioxide
- Animals fasted: No data
- How many animals: 10 per dose; males and females
- Parameters checked in table [No.1] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 5 and 21 (from satellite group) and at end of study for all animals
- Animals fasted: No data
- How many animals: 10 per dose; males and females
- Parameters checked in table [No.1] were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Kaplan-Meier method
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- 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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY - no treatment related effects
BODY WEIGHT AND WEIGHT GAIN - no treatment related effects
FOOD CONSUMPTION - protocol indicates measurements conducted, but not reported
HAEMATOLOGY - no treatment related effects
CLINICAL CHEMISTRY - no treatment related effects
ORGAN WEIGHTS - decrease seen in liver weights of males but not accompanied by histopathology changes; a liver enzyme increase was observed in males at day 5 but not at a later time period.
GROSS PATHOLOGY - no treatment related effects
HISTOPATHOLOGY: NON-NEOPLASTIC - protocol indicates examinations conducted, but not reported
OTHER FINDINGS - epidermal hyperplasia of the application site in both males and females at the highest dose - Dose descriptor:
- NOAEL
- Effect level:
- >= 800 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: other: overall effects: other: epidermal hyperplasia at highest dose in males
- Critical effects observed:
- not specified
- Conclusions:
- Results
Value: NOAEL = 400 mg/ml which equals 800 mg/kg bw active ingredient (a.i.)
NOAEL = (800 mg active ingredient/kg bw). - Executive summary:
Results
Value: NOAEL = 400 mg/ml which equals 800 mg/kg bw active ingredient (a.i.)
NOAEL = (800 mg active ingredient/kg bw).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 800 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The NOAEL was 800 mg/kg bw per day, on the basis of epidermal hyperplasia
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- As per OECD 411 with the exception of clinical signs recorded weekly, no food consumption, no ophthalmoscopy, clinical
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- CAS Number: 1300-72-7
Identity: Xylene sulfonic acid, sodium salt
Purity: 65%
Remarks: purity 65% (11.5% ortho, 38% meta and 15.5% para). - Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: 6 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 1 animal per cage; polycarbonate cage with stainless steel rack (rotated every 2 weeks); heat-treated hardwood chips and spun-bonded polyester cage filters changed weekly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 to 24.5
- Humidity (%): 20 to 67
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Vehicle:
- ethanol
- Details on exposure:
- TEST SITE
- Area of exposure: clipped interscapular skin
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: once at start of study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 microliters
- Concentration (if solution): 0, 5, 15, 44, 133, 400 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): ethanol because test material beads up rather than spreads out when applied neat
- Amount(s) applied (volume or weight with unit): 300 microliters of combined test material and vehicle
- Concentration (if solution): 50% solution of ethanol i water
- Lot/batch no. (if required): no data
- Purity: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC on each dose at beginning, middle and end of the study
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days per week
- Remarks:
- Doses / Concentrations:
5, 15, 44, 133 and 400 mg/ml (vehicle 50% ethanol, volume applied 0.3 ml) which averaged approximately 6, 20, 60, 170 and 500 mg a.i./kg for males and
10, 30, 90, 260 and 800 mg a.i./kg for females taking into consideration the 65% purity of the substance; solutions/suspensions were prepared every 2
weeks; feeding ad libitum. - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Dose selection rationale: wide range of doses for screening
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: 10 males and 10 females at each dose for special hematology and clinical chemistry study
- Post-exposure recovery period in satellite groups: no data
- Section schedule rationale (if not random): random - 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: weekly
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 5 and 21 (from satellite group) and at end of study for all animals
- Anaesthetic used for blood collection: Yes / carbon dioxide
- Animals fasted: No data
- How many animals: 10 per dose; males and females
- Parameters checked in table [No.1] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 5 and 21 (from satellite group) and at end of study for all animals
- Animals fasted: No data
- How many animals: 10 per dose; males and females
- Parameters checked in table [No.1] were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Kaplan-Meier method
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- 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 examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY - no treatment related effects
BODY WEIGHT AND WEIGHT GAIN - no treatment related effects
FOOD CONSUMPTION - protocol indicates measurements conducted, but not reported
HAEMATOLOGY - no treatment related effects
CLINICAL CHEMISTRY - no treatment related effects
ORGAN WEIGHTS - decrease seen in liver weights of males but not accompanied by histopathology changes; a liver enzyme increase was observed in males at day 5 but not at a later time period.
GROSS PATHOLOGY - no treatment related effects
HISTOPATHOLOGY: NON-NEOPLASTIC - protocol indicates examinations conducted, but not reported
OTHER FINDINGS - epidermal hyperplasia of the application site in both males and females at the highest dose - Dose descriptor:
- NOAEL
- Effect level:
- >= 800 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: other: overall effects: other: epidermal hyperplasia at highest dose in males
- Critical effects observed:
- not specified
- Conclusions:
- Results
Value: NOAEL = 400 mg/ml which equals 800 mg/kg bw active ingredient (a.i.)
NOAEL = (800 mg active ingredient/kg bw). - Executive summary:
Results
Value: NOAEL = 400 mg/ml which equals 800 mg/kg bw active ingredient (a.i.)
NOAEL = (800 mg active ingredient/kg bw).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 4.49 mg/cm²
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) /
Treated surface in cm2) NOAELtest* 0.25/44.5= NOAELmodified The highest dose not causing irritation/corrosion was 800 mg/kg bw in dermal toxicity study in rats
The modified dose descriptor would be:
NOAELmodified =800 mg/kg*0.25 kg/44.5cm2=4.49mg/cm2
Additional information
Justification for classification or non-classification
Based on the hazard assessment of sodium cumenesulfonate e in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Repeated dose toxicity R33 Danger of cumulative effects. T; R48/23 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation. T; R48/23/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. T; R48/23/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/23/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. T; R48/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin. T; R48/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. T; R48/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure if swallowed. Xn; R48/20 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation. Xn; R48/20/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. Xn; R48/20/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed. Xn; R48/20/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed. Xn; R48/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin. Xn; R48/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed. Xn; R48/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure if swallowed |
CLP |
Repeated dose toxicity STOT Rep. Exp. 1 STOT Rep. Exp. 2 H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. |
It is concluded that the substance sodium cumenesulfonate does not meet the criteria to be classified for human health hazards for Repeated dose toxicity
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