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EC number: 269-212-0 | CAS number: 68201-32-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-09-18 to 1985-10-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA requirements, 40 CFR 158.135
- Deviations:
- no
- Principles of method if other than guideline:
- Method References: Acute oral toxicity study in rats-EPA Assessment Guidelines, Subdivision F: Hazard Evaluation: Human and Domestic Animals, Series 81-1 (November 1982) and Revised Acute Toxicity Testing Guidelines, Acute Exposure Oral Toxicity, October 1984. Good Laboratory Practice Standards, Federal Register, November 29, 1983.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Soltex product #2
- IUPAC Name:
- Soltex product #2
- Reference substance name:
- Soltex contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)
- IUPAC Name:
- Soltex contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)
- Details on test material:
- - Name of test material (as cited in study report): Soltex Product #2
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: dark brown granular material
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: Initial body weights of the males ranged from 252.4 to 299.0 g, and the initial body weights of the females ranged from 227.6 to 264.7 g
- Fasting period before study: Food was withheld overnight before test substance administration, but water was available.
- Housing: Animals were maintained individually in elevated wire-mesh cages.
- Diet (e.g. ad libitum): ad libitum except during fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ~1 week
ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): Animal quarters were temperature-controlled. No further information was provided.
- Humidity (%): Animal quarters were humidity-monitored. No further information was provided.
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1985-10-02 To: 1985-10-16
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Polar Distilled Water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: N/A
- Amount of vehicle (if gavage): dosage factor was 20 mL/kg
- Justification for choice of vehicle: N/A
- Lot/batch no. (if required): 51267
- Purity: N/A
MAXIMUM DOSE VOLUME APPLIED: N/A
DOSAGE PREPARATION (if unusual):The required amount of test substance was weighed on an appropriate balance and placed into pre-calibrated glass beakers. Distilled water was added to each beaker to bring the mixture to the desired volume. The mixtures were stirred on a Tekmar Tissue Miser for approximately 2-3 minutes and then on a magnetic stirrer for approximately 3-4 minutes. All mixtures were stirred while dosing. The test substance was assumed to be 100 % pure for purposes of dosage calculations.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose level was selected based on a range-finding study. - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after administration and once daily thereafter to 14 days. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment, at 7 days and at termination.
- Necropsy of survivors performed: yes; observations were recorded.
- Other examinations performed: N/A - Statistics:
- N/A
Results and discussion
- Preliminary study:
- Materials and Methods:
-One rat/sex was dosed at levels of 1000, 2000, 3000, 4000 and 5000 mg/kg bw (initial body weights of males ranged from 205.7 to 221.8 g, and the initial body weights of females ranged from 203.0 to 236.1 g).
-Each animal was observed for signs of toxic and pharmacologic effects at 1, 2, 4, 24 and 48 hours after administration. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment and at termination. At termination, all rats were sacrificed and observations were recorded.
Results:
-No animals were found dead.
-Clinical signs were limited to instances of soft feces and/or a rough coat in all groups at one or more intervals. All animals gained weight from initiation to termination.
- Gross pathology findings noted were limited to pale adrenals in Groups 1-3 (1000 mg/kg, 2000 mg/kg, and 3000 mg/kg) and Group 5 (5000 mg/kg) males and in Group 2 (2000 mg/kg) and Groups 4-5 (4000 mg/kg and 5000 mg/kg) females, and dark adrenals were noted in the Group 4 (4000 mg/kg) males.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- No animals died in the study.
- Remarks on result:
- other: equivalent to an LD50 of >4250 mg SAS/kg bw
- Mortality:
- No animals were found dead.
- Clinical signs:
- other: -Clinical signs noted consisted of soft feces in three males and all females at one hour post dose, in all animals at two and four hours, and a rough coat in all animals on Day 1. All animals appeared normal from Day 2 through termination.
- Gross pathology:
- No observable gross pathology was noted in any of the animals upon necropsy.
- Other findings:
- N/A
Any other information on results incl. tables
N/A
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the results of this study, the LD50 was estimated to be greater than 5000 mg/kg of body weight in both female and male rats.
- Executive summary:
N/A
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