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EC number: 271-867-2 | CAS number: 68610-51-5
- 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:
- March 1989 - July 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Performed in accordance with a common test guideline (at the time) in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no urinalysis
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- EC Number:
- 271-867-2
- EC Name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- Cas Number:
- 68610-51-5
- Molecular formula:
- C10H12.C7H8O.C4H8
- IUPAC Name:
- 2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol
- Details on test material:
- - Name of test material (as cited in study report): Wingstay L
- Substance type: off-white powder
- Physical state: powder (solid)
- Analytical purity: not specifically stated in the report, considered 100% pure
- Impurities (identity and concentrations): not stated in the report
- Composition of test material, percentage of components: not stated in the report
- Purity test date: not stated in the report
- sample number: 8408-112-1
- Lot/batch No.: 809191
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: determined at day 10, within 10% range of deviation
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Fortage, Michigan
- Age at study initiation: 7 weeks
- Weight at study initiation: Males: 176-379 g; Females: 146-185 g
- Fasting period before study: no
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 67 – 75 ◦F (19 – 24 ◦C)
- Humidity (%): 38-90
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: March 22, 1989 To: July 7, 1989
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: not applicable
DIET PREPARATION
- Rate of preparation of diet (frequency): diet preparation was performed at least twice during the study, because the methodology was revised as from week 7. However, the actual frequency of diet preparation remains unclear
- Mixing appropriate amounts with (Type of food): rodent meal
- Storage temperature of food: not described
VEHICLE
- Justification for use and choice of vehicle (if other than water): not provided
- Concentration in vehicle: : 500,1500, 4500 ppm in diet
- Amount of vehicle (if gavage): not applicable
- Lot/batch no. (if required): 809191 (test compound)
- Purity: 100% (test compound) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- homogeneity and concentration of substance in diet was determined by HPLC analysis
analytical conditions:
Hitachi HPLC system with UV-detector and autosampler
column: Alltech Mixed mode RP-18/cation, 7 micron
mobile phase: water; acetonitrile (15:85)
flow rate: 1 ml/min
detction: UV at 280 nm
injection volume: 10 uL
internal standard: tri-t-butylphenol
standard solutions in 2-propanol
Wingstay L consists of several components, therefore the integrator was programmed to sum the areas of all relevant peaks and to calculate and report them as 1 peak. - Duration of treatment / exposure:
- 91-92 days
- Frequency of treatment:
- continuous, via diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500,1500, 4500 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15 males and 15 females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: based on a previously conducted study
- Rationale for animal assignment (if not random): not applicable
- Rationale for selecting satellite groups: not applicable
- Post-exposure recovery period in satellite groups: not applicable
- Section schedule rationale (if not random): not applicable - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations checked in table [No.?] were included. …not applicable
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
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 AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations: …not applicable
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to study initiation and in week 12
- Dose groups that were examined: …all animals of all groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: days 91 or 92 (at termination)
- Anaesthetic used for blood collection: No
- Animals fasted: Yes
- How many animals: 10/sex/group
- Parameters checked in table [No.?] were examined. Standard parameters
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: days 91 or 92
- Animals fasted: Yes
- How many animals: 10/sex/group
- Parameters checked in table [No.?] were examined. Standard parameters
URINALYSIS: No
- Time schedule for collection of urine: not applicable…
- Metabolism cages used for collection of urine: Yes / No / No data Not applicable
- Animals fasted: Yes / No / No data Not applicable
- Parameters checked in table [No.?] were examined. not applicable
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: none - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- none
- Statistics:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: One control male with a mechanical injury was sacrificed in week 9. No treatment-related clinical signs
BODY WEIGHT AND WEIGHT GAIN: lower weight gains at 4500 ppm in first treatment week
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): lower food intake at 4500 ppm in first treatment week (considered to be related to palatability)
FOOD EFFICIENCY: no data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study) : no data
OPHTHALMOSCOPIC EXAMINATION: No lesions indicative of a toxic effect were observed
HAEMATOLOGY: increased mean prothrombin time (PT) and activated partial thromboplastin time (APTT) in males at 4500 ppm and non-significant increase of APTT at 1500 ppm in males
CLINICAL CHEMISTRY: No treatment-related findings
URINALYSIS: No data
NEUROBEHAVIOUR: no data
ORGAN WEIGHTS: increased absolute and relative weights of liver and adrenals at 1500 and 4500 ppm
GROSS PATHOLOGY: No treatment-related findings
HISTOPATHOLOGY: NON-NEOPLASTIC: no treatment-related findings
HISTOPATHOLOGY: NEOPLASTIC (if applicable) : not applicable
HISTORICAL CONTROL DATA (if applicable) applied for interpretation of clinical chemistry findings
OTHER FINDINGS: none
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- haematology
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
The higher weights of liver and adrenals at 1500 and 4500 ppm had no morphological correlate and may not be indicative of adverse effects. The increase in APTT was considered to be indicative of an effect on intrinsic clotting factors, which would be an adverse effect. As APTT was already increased at 1500 ppm the possibly correlated higher liver weights are considered as adverse. The low-dose level of 500 ppm (32 mg/kg bw/day) is established as the NOAEL.
conversion ppm to mg/kg bw/day:
500 ppm: male - 32 mg/kg bw/day, female - 38 mg/kg bw/day
1500 ppm: male - 96 mg/kg bw/day, female - 117 mg/kg bw/day
4500 ppm: male - 289 mg/kg bw/day, female - 339 mg/kg bw/day
Applicant's summary and conclusion
- Conclusions:
- A dose level of 500 ppm Wingstay L was considered to be a NOAEL when administered to rats for at least 90 days.
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