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EC number: 262-975-0 | CAS number: 61788-44-1
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
Repeated dose oral toxicity study was conducted to determine the toxic nature of the test chemical. The study was performed using male and female rats for 36 weeks. During the study, the animals were observed for clinical signs, mortality, body weight changes, gross pathology. Statistically lower body weights at 158 and 500 mg/kg/day (body weight gain not reported). Report states that growth was depressed only at 500 mg/kg/day. Increased liver and kidney weights relative to body weight. The chronic repeated dose toxicity NOAEL( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of the test chemical to male/female rats by oral (feed) route was observed at a dose concentration of 150 mg/kg bw/day and 500 mg/kg bw/day in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.
Repeated dose toxicity: Inhalation
Phenol styrenated (CAS no 61788-44-1) has very low vapor pressure of 0.00075 mmHg at 20°C. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
The acute dermal toxicity value for Phenol, styrenated (as provided in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that Phenol, styrenated shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Phenol, styrenated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from study report
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- 90 day oral feeding study in rats was conducted to determine the toxic nature of the test chemical.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No details available
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 36 Weeks
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
Five levels ranging from 5 to 500 mg/kg/day
Basis:
no data - No. of animals per sex per dose:
- No data available
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- Body weight:Yes
Organ weight:Yes
Organ examined-Liver weight - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes
Biochemical examination:Yes - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically lower body weights at 158 and 500 mg/kg/day (body weight gain not reported). Report states that growth was depressed only at 500 mg/kg/day.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased liver and kidney weights relative to body weight (no absolute organ weights reported).
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histopathology and clinical pathology examinations were conducted.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 150 other: mg/kg-bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed in histopathological and biochemical examinations,body weght and organ weight.
- Dose descriptor:
- LOAEL
- Effect level:
- 500 other: mg/kg-bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect : growth depressed,incresed liver and kidney weight.
- Critical effects observed:
- not specified
- Conclusions:
- The chronic repeated dose toxicity NOAEL( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of the test chemical to male/female rats by oral (feed) route was observed at a dose concentration of 150 mg/kg bw/day and 500 mg/kg bw/day respectively in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.
- Executive summary:
Repeated dose oral toxicity study was conducted to determine the toxic nature of the test chemical. The study was performed using male and female rats for 36 weeks. During the study, the animals were observed for clinical signs, mortality, body weight changes, gross pathology. Statistically lower body weights at 158 and 500 mg/kg/day (body weight gain not reported). Report states that growth was depressed only at 500 mg/kg/day. Increased liver and kidney weights relative to body weight. The chronic repeated dose toxicity NOAEL( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of Phenol, styrenated to male/female rats by oral (feed) route was observed at a dose concentration of 150 mg/kg bw/day and 500 mg/kg bw/day in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from secondary source
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the target chemical and its read across chemical was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:
Repeated dose toxicity: Oral
Repeated dose oral toxicity study was conducted to determine the toxic nature of the test chemical. The study was performed using male and female rats for 36 weeks. During the study, the animals were observed for clinical signs, mortality, body weight changes, gross pathology. Statistically lower body weights at 158 and 500 mg/kg/day (body weight gain not reported). Report states that growth was depressed only at 500 mg/kg/day. Increased liver and kidney weights relative to body weight. The chronic repeated dose toxicity NOAEL( No observed adverse effect level) and LOAEL (Lowest observed adverse effect level) of the test chemical to male/female rats by oral (feed) route was observed at a dose concentration of 150 mg/kg bw/day and 500 mg/kg bw/day in a 36 weeks study period where the dosage of the test chemical was daily given to rats orally.
Subchronic repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using male and female rats for 90 days. During the study, the animals were observed for clinical signs, mortality, body weight and organ weight changes, gross pathology and histopathology. At 158 and 500 mg/kg/day, body weights gain were significantly lower than controls. Liver weights relative to body weights were higher than controls. (No absolute organ weight reported).) Minimal focal thyroid hyperplasia was observed at 500 mg/kg/day. No adverse effects were noted in the clinical pathology evaluations (including coagulation and prothrombin time.). Based on the observations made, the no observed adverse effect level (NOAEL) or the test chemical is considered to be 50 mg/Kg/day when male and female rats were exposed to the test chemical for 90 days.
Repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed for 3 months using male and female F344/N rats. The test chemical was dissolved in corn oil and used at dose level of 0, 37.5, 75, 150, 300, or 600 mg/kg. Concurrent solvent control chemicals were also included in the study. All rats survived to the end of the study except one 600 mg/kg male and one 37.5 mg/kg female that were killed in dosing accidents. Mean body weights of all exposed groups of males were significantly less than that of the vehicle control group; however, only the decrease for the 600 mg/kg group exceeded 10% and was considered related to the test chemical exposure. Liver weights were significantly increased in 300 and 600 mg/kg females. The incidences of minimal atrophy of the olfactory epithelium of the nose were significantly increased in 150 mg/kg or greater males and in 300 or 600 mg/kg females. The incidence of atrophy of olfactory nerve bundles was significantly increased in 600 mg/kg females. Minimal to mild periportal hepatocellular cytoplasmic alteration occurred in all 300 or600 mg/kg females. Based on the observations made, the no observed adverse effect level (NOAEL) for the test chemical is considered to be 75 mg/Kg/day.
Repeated dose toxicity: Inhalation
Phenol styrenated (CAS no 61788-44-1) has very low vapor pressure of 0.00075 mmHg at 20°C. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
The acute dermal toxicity value for Phenol, styrenated (as provided in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that Phenol, styrenated shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Phenol, styrenated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the test chemicals and applying the weight of evidence approach, the test chemical does not exhibit toxic nature upon repeated exposure by oral route of administration. Hence the test chemical is likely to be non toxic as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the test chemicals and applying the weight of evidence approach, the test chemical does not exhibit toxic nature upon repeated exposure by oral route of administration. Hence the test chemical is likely to be non toxic as per the criteria mentioned in CLP regulation.
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