Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-249-4 | CAS number: -
- 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:
- 11th September 1996 to 24th January 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study following GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
- EC Number:
- 701-249-4
- Molecular formula:
- A molecular formula for this substance does not exist because it is a UVCB. The molecular formula for a theoretical representative structure is C36H58Ca2O4Sx where x = 1-3.
- IUPAC Name:
- Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
- Details on test material:
Phenol, dodecyl-, sulfurized, calcium salts
Testing was performed on a commercial sample of this material. Typical purity of this material as distributed in commerce is 60% alkyl phenol sulfide and 40% highly refined lubricant base oil.
Constituent 1
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 Laboratories
- Age at study initiation: approximately 9 to 10 weeks of age
- Weight at study initiation: 209 to 296 g
- Fasting period before study: yes, 17 to 20 hours before test material administration
- Housing: After test material administration, the animals were individually housed in suspended screen-bottom stainless steel cages.
- Diet/water (e.g. ad libitum): The animals were provided continuous access to Laboratory Rodent Diet #5001, PMI Feeds, Inc., and water except for 17 to 20 hours before test material administration when food, but not water, was withheld. The feed is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Samples of the water are periodically analyzed. There were no known contaminants in the feed or water at levels that could be expected to interfere with or affect the results of the study.
- Acclimation period: the animals were acclimated for a period of at least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 50% ± 20%,
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark lighting cycle
IN-LIFE DATES: From: To: 11th to 25th September 1996
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5 g/mL
- Amount of vehicle (if gavage): The prepared test material mixture appeared to be a suspension. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 10 mL/kg of body weight. - Doses:
- limit dose of 5000 mg/kg b. wt
- No. of animals per sex per dose:
- 5 male/female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: Clinical observations were conducted at 1, 2.5, and 4 hours after test material administration and daily thereafter for 14 days. Mortality checks were conducted twice a day (morning and afternoon) for 13 days after test material administration and again the morning of Day 14.
- Frequency of observations and weighing: Body weights were determined before test material administration (Day 0), at Day 7, at termination of the in-life phase (Day 14).
- Necropsy of survivors performed: yes, at termination of the in-life phase, all animals were euthanized by an overexposure to carbon dioxide, subjected to an abbreviated gross necropsy examination, and any abnormalities were recorded. After necropsy, the animals were discarded and no tissues were saved as there were no grossly abnormal tissues. - Statistics:
- No statistical analyses were required by the protocol.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg of body weight.
- Clinical signs:
- other: Clinical signs of toxicity included red-stained face, soft stool, and dark/yellow-stained urogenital area. All animals returned to a normal appearance by Day 7 after treatment.
- Gross pathology:
- There were no lesions observed at the terminal necropsy.
Any other information on results incl. tables
The acute oral toxicity of the test material was evaluated in male and female rats when administered as a single gavage dose at a level of 5,000 mg/kg of body weight. No mortality occurred during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg. Clinical signs of toxicity included red-stained face, soft stool, and dark/yellow-stained urogenital area. All animals returned to a normal appearance by Day 7 after treatment. All animals exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no visible lesions,
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 5000 mg/ kg b. wt. (males and females)
- Executive summary:
In a study conducted in line with OECD guideline 401 under condistions of GLP, the test material was evaluated for its acute oral toxicity potential in male and female rats when administered as a single gavage dose at a level of 5,000 mg/kg of body weight. No deaths occurred during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg. Clinical signs of toxicity included red-stained face, soft stool, and dark/yellow-stained urogenital area. All animals returned to a normal appearance by Day 7 after treatment. All animals exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no visible lesions.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.