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EC number: 700-516-2 | CAS number: 93413-62-8
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11/1989-03/1990
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Guideline followed not specified. In-vivo Chromosome aberration study in bone marrow
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol
- EC Number:
- 700-516-2
- Cas Number:
- 93413-62-8
- Molecular formula:
- C16H25NO2
- IUPAC Name:
- 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol
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: Taconic(Germantown, NY)
- Age at study initiation:7weeks
- Weight at study initiation:
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing: in suspended stainless steel cages with Easi-litter bedding
- Diet (e.g. ad libitum): Agway Standard Rodent Chow ad libitum
- Water (e.g. ad libitum):Cambridge City tap water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 to 30°C
- Humidity (%):
- Air changes (per hr):28 to 60%
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- Single OG dosage. Sacrifice after 6, 18 or 24 hours.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 500, 1500 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 18 rats/sex/group received at 150,500,1500mg/kg
5 rats/sex received Base at 3000mg/kg toxic dose, so not analysed
18 rats/sex received the vehicle (control)
6 rats/sex received 30mg/kg of cyclophosphamide (positive control) - Control animals:
- yes, concurrent vehicle
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- ambiguous
- Toxicity:
- yes
- Remarks:
- 4/6 females died at 1500mg/kg at 6hrs; 1/6 females died at 1500mg/kg at 24hrs
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Rats dosed at 3000 mg/kg were not analyzed due to toxicity. In females, 4/6 rats dosed at 1500 mg/kg (6-hour timepoint) and 1/6 rats dosed at 1500 mg/kg (24-hour timepoint) died prior to the scheduled sacrifice. No deaths occurred in males. An increase in the percent of cells with aberrations was noted in the 1500mg/kg males at the 6-hour sacrifice (4.8% cells with chromosomal aberrations compared to 1.6% for pooled negative controls and 2.4% in the six hour negative control). No increase in the percent of cells with aberrations or the number of aberrations per cell was seen at the 6-hour timepoint in the males treated with 150 or 500 mg/kg, in males at the 18 and 24 hour timepoints at any dose, or in any females. The positive and the negative controls showed the appropriate response indicating the assay was valid.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): ambiguous
The substance was administered as a single dose by oral gavage to male and female rats at 150, 500, and 1500 mg/kg to evalute its clastogenic potential. An increase in the percentage of cells with aberrations was seen in the 1500 mg/kg male group sacrificed 6 hours after treatment (4.8% as compared to 1.6% in the pooled control and 2.4% in concurrent controls); no increase were seen in the other male groups at 6 hours, in any male group at 18 or 24 hours, or in any female group at 6, 18, or 24 hours. This response was considered ambiguous but may indicate that the substance is a potential clastogen in male rats, however, no dose response was observed and no response was observed at 18 or 24 hours or in female rats. The response of the positive and negative controls indicated that assay was valid.
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