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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- "In Life" dates 12th to 19th September 1996
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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:
- rabbit
- Strain:
- other: Hra:(NZW)SPF strain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HRP, Inc., Kalamazoo, Michigan on September 4, 1996.
- Age at study initiation: approximately 13 weeks of age
- Weight at study initiation: weighing from 2,098 to 2,427 g
- Housing: the animals were individually housed in suspended stainless steel cages.
- Diet/water (e.g. ad libitum): The animals were provided access to water ad libitum and a measured amount of Laboratory Rabbit Diet HF #5326, PMI Feeds, Inc. 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: After receipt, the animals were acclimated for a period of at least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19° to 23 °C
- Humidity (%): 50% +20%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark lighting cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): The undiluted test material was applied to the intact skin site on each animal's back (approximate exposure area of 6.25 cm2) in the amount of 0.5 mL. - Duration of treatment / exposure:
- four hours
- Observation period:
- 4, 24, 48, 72, 96 hours and 7 days.
- Number of animals:
- Three per sex per dose (male and female)
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: The area of application was covered with a 4-ply 2.5-cm x 2.5-cm gauze patch secured with two strips of Micropore surgical tape. The trunk of the animal was then loosely overwrapped with a sheet of perforated plastic film that was secured on both ends with strips of Elastoplast® tape to provide a semiocclusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4-hour exposure period, the patches were removed and any remaining test material was removed from the test sites using mineral oil followed by liquid Ivory® soap mixed with warm tap water. The test sites were then rinsed with clean tap water and dried with disposable paper towels. The test material was removed from the test sites as thoroughly as possible without irritating the skin. The area of control skin was treated in the same manner.
SCORING SYSTEM:
Thirty minutes after removal of the test material, the degree of erythema and edema at each test site was read according to the Draize technique (recorded as the 4-hour score). Subsequent examinations were made at 24, 48, 72, and 96 hours and Day 7. An area of untreated skin on each animal was used for comparison.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 2.8
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: The primary dermal irritation index (PDII) is the sum of the individual index scores, divided by the number of animals, and rounded to the nearest tenth.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Application of the test material to the skin of rabbits under 4-hour semioccluded conditions resulted in very slight to well-defined erythema and slight to moderate edema reactions. No other dermal irritation was observed. All irritation cleared by the Day 7 observation.
Any other information on results incl. tables
The average of the individual animal index scores is 2.8. The average of the 24-, 48-, and 72-hour scores are 1.2 for erythema and 1.3 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced very slight to well-defined erythema and slight to moderate edema reactions. No other dermal irritation was observed. All irritation cleared by the Day 7 observation.
- Executive summary:
In an acute dermal irritation study in the New Zealand White Rabbit conducted to OECD guideline 404 in accordance with GLP, the primary dermal irritation potential of the test material was evaluated in rabbits under 4-hour semi-occluded conditions. The test material produced very slight to well-defined erythema and slight to moderate edema reactions. No other dermal irritation was observed. All irritation cleared by the Day 7 observation. The average of the individual index scores (the total of the erythema and edema scores at 4, 24, 48, and 72 hours divided by 4) is 2.8. The average of the 24-, 48-, and 72-hour scores are 1.2 for erythema and 1.3 for edema.
The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1.2 and so will not be classified as irritating.
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