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Diss Factsheets
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EC number: 811-484-5 | CAS number: 680972-33-2
- 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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- other: Read across from category (Hydrotropes)
- Adequacy of study:
- supporting study
- Study period:
- July 20-August 6, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Protocols and resuls reviewed and accepted by the National Toxicology Program's Board of Scientific Counselor's Technical Reports Review Subcommittee, USA National Institutes of Health. The study was used as dose finding study for a carcinogenicity study and therefore the number of endpoints was limited.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- yes
- Remarks:
- 17 day only
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium xylenesulfonate
- IUPAC Name:
- Sodium xylenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): sodium xylene sulfonate- Molecular formula (if other than submission substance): no data- Molecular weight (if other than submission substance): no data- Substance type: organic- Physical state: powder- Analytical purity: 65%- Impurities (identity and concentrations): not identified from NMR spectrum provided- Composition of test material, percentage of components: 11.5% ortho, 38% meta, 15.5% para- Purity test date: February 13, 1986- Lot/batch No.: RO92085 / 03- Expiration date of the lot/batch: no data- Stability under test conditions: stable- Storage condition of test material: glass bottles with Teflon lined caps or double bagged in metal drums at room temperature in the dark- Other:
Constituent 1
Test animals
- 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: 5 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 1 animal per cage; polycarbonate cage on stainless steel racks with heat-treated hardwood chips and spun-bonded polyester filters; changed once per week
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 to 25.6
- Humidity (%): 51 to 68
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: July 20 To: August 6, 1987
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- 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
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 microliters applied five days per week
- Concentration (if solution): 0, 5, 15, 44, 133 and 400 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): distilled water
USE OF RESTRAINERS FOR PREVENTING INGESTION: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- doses analyzed by HPLC at the start of the 17 day period
- Duration of treatment / exposure:
- 17 days
- Frequency of treatment:
- 5 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 30, 90, 260 and 800 mg active ingredient/kg bw for males, and 13, 40, 120, 330 and 1030 mg active ingredient/kg bw for females
Basis:
analytical per unit body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: wide range for screening purposes
- Rationale for animal assignment (if not random): random - Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 1, 8 and 17
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / 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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (Table F1)
HISTOPATHOLOGY: Yes - Statistics:
- Kaplan-Meier method
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional 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 mortality; only tan or brown discoloration of the skin and crusty white deposits at the application site
BODY WEIGHT AND WEIGHT GAIN - no treatment effects
ORGAN WEIGHTS - increase in liver weights relative to body weight in males and females at two highest doses; considered to be of unknown toxicological relevance
GROSS PATHOLOGY - no treatment related effects
HISTOPATHOLOGY: NON-NEOPLASTIC - no treatment related effects
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 030 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects clinical signs; mortality; body weight; gross pathology; organ weights; histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL = highest dose (1030 mg active ingredient/kg bw).
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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