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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June - September 1983
- 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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sodium p-cumenesulphonate
- EC Number:
- 239-854-6
- EC Name:
- Sodium p-cumenesulphonate
- Cas Number:
- 15763-76-5
- Molecular formula:
- C9H12O3S.Na
- IUPAC Name:
- sodium 4-isopropylbenzenesulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Bor: WISW (SPF TNO)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, 4799 Borchen
no further details mentioned
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks / 90 days
- Frequency of treatment:
- daily (7 days/week)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 200 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10, additionally 10 for recovery (control and high dose group)
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: previous range finding test
3 weeks, 4 dosages (0 control group, 400; 800; 1200 mg/kg bw/d) and 1 control group (10 animals)
2 different tests (40 rats, 20 males and 20 females) were divided into 4 groups (5 animals/sex/dose)
a) drinking water
b) food
Body weights, feed and water consumption were calculated weekly. The test substance was applied continuously on all days during the 3-weeks test period. - Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Observations: general appearance and behaviour
- Time schedule: a few times/day
DETAILED CLINICAL OBSERVATIONS: a few times/day
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: all anminals, before application, weeks 6-7, 12-13, recovery group (17 = 4 weeks later)
HAEMATOLOGY: Yes
- Time schedule for collection of blood: weeks 6-7, 12-13 and recovery group (17 = 4 weeks later)
- Anaesthetic used for blood collection: ether
- Animals fasted: no
- How many animals: all
- Parameters: WBC, RBC, Hb, Hct, MCH, MCV, MCHC, thrombocytes, differential hemogram, number of reticulocytes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: weeks 6-7, 12-13, recovery group (17 = 4 weeks later)
- Animals fasted: no
- How many animals: all
- Parameters: glucose, kreatinine, urea, total bilirubin, proteine, chloride, phosphate, GOT, GPT, gamm-GT, cholesterine, triglyceride, Na, K
URINALYSIS: Yes
- Time schedule for collection of urine: urinalysis from pooled samples (6 hours)
- Metabolism cages used for collection of urine: yes
- Animals fasted: no data
- Parameters checked: pH, glucose, ketone, urobilinogene, proteine, blood, specific density, native sediment with microscope
NEUROBEHAVIOURAL EXAMINATION: Not mentioned - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Organs examined histologically
Eyes (cornea, iris, retina) (2x)
Adrenal gland
Cerebrum (Ammon's horn)
Peripheral nerve
Cerebellum (stem)
Forestomach
tongue
Drusen stomach (fundus, pylorus)
Salivary gland
Small intestine (3x)
Maxillary lymph nodes
Large intestine (3x)
Esophagus
Mesenteric lymph nodes
Windpipe (trachea)
Uterus (2x)
Lungs (2x)
Ovary (2x)
heart
bladder
Thoracic aorta
Prostate (2x)
liver
Testicles (2x)
spleen
Epididymis (2x)
pancreas
Seminal vesicle (2x)
Cardioid (2x)
Skeletal muscles
thymus
skin
Thyroid gland, parathyroid gland - Other examinations:
- Main test: Intermediate examinations (urine, hematology, clinical chemistry) on all animals during the 6th and 7th week of application) Final examinations (urine, hematology, clinical chemistry) on the animals, which are dissected at the end of the application, during the 12th and13th week.
General and eye examinations on all animals are carried out at the beginning of the application, on the occasion of the intermediate examinations, at the end of the application and on the recovery animals at the end of the observation period.
Body weights, food and water consumption (substance intake) are calculated on a weekly basis. Checks of the general condition of the animals are carried out several times a day.
The blood is taken from the retroorbital venous plexus of the test animals
under ether anesthesia (Ether pro narcosi, Hoechst).
The following parameters are determined:
a) clin. chemistry
Glucose, creatinine, urea, total bilirubin, total protein, chloride, phosphate, GOT, SPT, y-GT, cholesterol and triglycerides with RA-1000 system (Tech "-
nicon) as well as Na and K ion-selective with the Electrolyte Analyzer 980 (AVL).
b) hematology
All blood tests were performed on non-fasting animals. The blood was drawn from the infraorbital plexus under light atheric anesthesia.
The rats were placed in metabolism cages for 6 hours for urine testing. The microscopic examination was carried out on the native sediment, other investigations using Combur-6 test strips (Boehringer, Mannheim).
The parameters checked are: WBC, RBC, Hb, Hct, MCH, MCV, MCHC and platelets with the Counter S plus (from Coulter) as well
Differential blood count and reticulocyte count microscopically.
To collect urine, the animals are placed in metabolism cages for 6 hours. Test strips (Boehringer) are used to determine the pH, glucose, ketone, urobilinogen, protein and blood in the urine. The specific weight is determined by weighing.
The native sediment is assessed microscopically.
Results and discussion
Results of examinations
- 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:
- no effects observed
- Description (incidence and severity):
- In hematology, there were no treatment-dependent trends in reductions after an initial review:
IV group
males: RBC, HB, HCT signif. lowered, but within the normal range
females: segment nuclear signif. increased, but within the normal range
Lymphocytes signif. lowered (3/20 fall just outside the normal range)
III
males: RBC (not signif.), HB, HCT signif. lowered, but within the normal range
Final examination In the 12./13. Appl. week
VI
males: monocytes signif. decreased, but within the normal range
females: reticocytes signif. decreased, but within the normal range
III group
males: WBC signif. decreased, but within the normal range. females: segment nuclear signif. increased, but within the standard range
II group
males: WBC signif. decreased, but within the normal range of lymphocytes significant. increased but within the normal range
Segmented nuclei and monocytes signif. decreased, but within the normal range
Recovery examination in the 4th week of follow-up
IV group
males: Eosinophils signif. increased but within the normal range
females: reticulocytes signif. decreased, but within the normal range - Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Interim examination
IV group
males: BUN (urea), signif. elevated
GPT, total protein and triglycerides
signif. decreased, but within the normal range
females: K signif. decreased (but only 1/20 outside the normal range Phosphorus and GPT, significantly decreased, but within the normal range
III group
males: BUN signif. elevated
Cholesterol and GPT signif. decreased, but within the normal range
II group
males: GOT signif. decreased, but within the normal range
females GOT and creatinine
signif. decreased, but within the normal range
Final examination
IV group
males: BUN signif. elevated
Cholesterol signif. decreased, but within the normal range
females: cholesterol signif. decreased, but within the normal range
Ill group
males: cholesterol signif. decreased (but only 1/10 outside the normal range)
GPT and Phosphorus signif. humiliated
but within the normal range
II group
males: cholesterol and phosphorus signif. decreased, but within the normal range
Recovery investigation
IV group
Na signif. humiliated - Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- 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 specified
- Other effects:
- not specified
- Details on results:
- Results of the dose range findings
The dose-tange finding show no substance specific effects (body weight gain, pathological, histopathological effects, clinical signs, behaviour)
There were no significant differences between dose and control groups in either experiment. In the female animals, however, there seems to be a dose-dependency in the feed conversion.In the behavior of the animals and in the final examination before the dissection, no substance-dependent observations could be made.
The macroscopic assessment did not reveal any evidence of pathological changes that could be substance-dependent. According to Henkel's autopsy protocol, there were no histological changes in the organ assessed, whIch would indicate the effect of the substance.
Main test
The pathological-anatomical examinations of the animals in the main study do not show any indications of changes caused by the test substance.
For the main test OW 90d-003, the dosages of the previous tests were therefore retained. The substance administration via drinking water was chosen as the form of administration.
The substance is administered 7 days a week. 120 Wistar rats were used for the experiment; from the control and the highest dose group (20 males and 20 females animals), after the end of the dose, half of the animals remain in a 4-week observation period. The pathological-anatomical examination does not give any indications of changes caused by the test substance.
Some pathological-histological findings (salivary gland, pancreas) indicate the presence of virus-related sialodacryoadenitis.
The findings of the fore and glandular stomach are low overall and cannot be assigned to a defined clinical picture. However, they are represented in Groups I and IV.
The slight to moderate loss of the external granular layer in the retina of the eyes is posture-related (exposure to light) and mainly affects the female and male animals of group I.
Another spontaneous finding concerns a large number of urinary bladders in the animals of the main and "recovery" groups. Morphologically, the diapedesis of erythrocytes and / or plasma components from the wall vessels through the transitional epithelin of the urinary bladder lumen can be observed. Sometimes this material has pushed the epithelial structure apart. This results in moderate to high-grade circumscribed epithelial proliferation with low-grade, chronically inflammatory infiltrates in the submucosa. There are no signs of bacterial infection, which is usually the cause of cystitis in rats.
In conclusion there are no pathological or histological indications of changes due to the test substance.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 200 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 1200 mg/kg bw day (highest dose tested) based on active ingredient
- Executive summary:
The repeated oral toxicity of Sodium p-cumenesulphonate was assessed following official guideline OECD 408, Repeated Dose 90-Day Oral Toxicity Study in Rodents. The tested substance showed very low order of toxicity. The pathological-anatomical examinations of the animals in the main study do not show any indications of changes caused by the test substance.
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