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EC number: 220-103-6 | CAS number: 2628-17-3
- 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:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September to 11 December 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- This is a range-finding study.
- Limit test:
- no
Test material
- Reference substance name:
- p-vinylphenol
- EC Number:
- 220-103-6
- EC Name:
- p-vinylphenol
- Cas Number:
- 2628-17-3
- Molecular formula:
- C8H8O
- IUPAC Name:
- p-vinylphenol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Maruzen Petrochemical Co.Ltd./ Bx 7831WJD
- Expiration date of the lot/batch:
- Purity test date:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Opaque airtight container at -30°C to -10°C
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS:
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Females: nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: Barrier-system animal rooms
- Diet: autoclaved pelleted diet ad libitum.
- Water:. ad libitum
- Acclimation period: 6 days
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10-15
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- The animals were orally treated by gavage for 14 days daily with a syringe connected to a catheter at dosing volumes of 5 ml/kg based on body weight
- Vehicle:
- other: Gum arabic
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- The animals were orally treated by gavage for 14 days daily
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- control
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- Daily before and after dosing
- Sacrifice and pathology:
- Any surviving animals were euthanised at the end of the study. A full pathological examination took place.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- In males, salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacrimation, incomplete eyelid opening were observed and all animals were dead in the 1000 mg/kg.bw group on day 1.
Salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacrimation, incomplete eyelid opening were observed and all animals were dead in the 500 mg/kg.bw group on day 1.
Salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacrimation, incomplete eyelid opening were observed and all animals were dead in the 200 mg/kg.bw group on day 1.
Decreased spontaneous locomotion and decreased respiratory rate were observed in one of the 50mg/kg group from day 2 to day 4.
In females, prone position, lateral position, colonic convulsion, decreased spontaneous locomotion, incomplete eyelid opening were observed and all animals died in the 1000 mg/kg group on day 1.
Salivation, lateral position,colonic convulsion, decreased spontaneous locomotion, incomplete eyelid opening were observed and all animals died in the 500 mg/kg group.
Decreased spontaneous locomotion, lacrimation, incomplete eyelid opening, decreased respiratory rate, sub-normal temperature were observed in the 200 mg/kg group on day 1. One animal in the 200 mg/kg group had a shuffling gate from day 2 and salivation, anorexia, decreased stool volume were observed on day 3 and this animal was euthanised on day 3. No abnormalities were observed in the 50 mg/kg group. - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Reported above
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- For males decreased body weigh was observed in the 200 mg/kg group. No affect was observed on the 50mg/kg group.
In females, decreased body weights were observed in 200 and 50 mg/kg groups. - 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):
- effects observed, treatment-related
- Description (incidence and severity):
- Details reported above in clinical signs
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- No abnormal organ weights were observed in the surviving animals in the 50 and 200 mg/kg groups
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In males, reddish change of the wall of the forestomach, pseudomembrane on the mucosa of the glandular stomach, bilateral dark reddish change in the kidneys , dark reddish urine in the urinary bladder were observed in the dead animals of the 1000mg/kg group.
Edematous change and reddish change of the wall of the forestomach, pseudomemberane on the mucosa of the glandular stomach, bilateral dark reddish change and enlargement of the kidneys, blackish contents and dark reddish urine in the urinary tract were observed in dead animals of the 500 mg/kg group.
Elevation of the limiting ridge of the forestomach was observed in the 200 mg/kg group. Staining around the nose and mouth, thickening of the wall of the oesophagus, roughening of the mucosa of the forestomach, distention with gas of the duodenum, jejunum and ileum were observed in one euthanised animal of the 200 mg/kg group. Abnormal necrotic changes were observed in the 50 mg/kg group.
In females, reddish change of the wall of the forestomach, pseudomembrane on the mucosa of the glandular stomach, bilateral dark reddish changes of the kidneys were observed in the dead animals of the 1000 mg/kg group.
Edematous change and reddish change of the wall of the forestomach, bilateral dark reddish change of the kidneys, dark reddish urine in the urinary tract were observed in the dead animals of the 500 mg/kg group.
Elevation of the limiting ridge of the forestomach was observed in the 200 mg/kg group. Thickening of the wall of the oesophagus, edematous change of the wall of the forestomach, pale spleen was observed in one euthanised animal in the 200 mg/kg group. necrotic changes were not observed in the 50 mg/kg group. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- < 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- gross pathology
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- bladder
- duodenum
- ileum
- intestine
- jejunum
- kidney
- oesophagus
- stomach
- ureter
- urethra
Applicant's summary and conclusion
- Conclusions:
- The toxic changes in this fourteen day study are similar to those of phenol (EC 203-632-7 CAS 108-95-2), corrosive and chemical burns at contact site, transient CNS stimulation followed by CNS depression, coma, seizures, diarrhoea, methemoglobinaemia, etc. (ASTDR 2017)
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