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EC number: 217-886-1 | CAS number: 1999-85-5
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 22 June 2011 - 08 July 2011
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The study has many deviations and the information in the report is incomplete.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- The study has many deviations and the information in the report is incomplete.
- No data on range finding
- No information on toxicity included in the report, decrease in PCE/NCE ratio or clinical signs? No proof that the test subsatnce reached the target
- Results for the individual animals not reported
- No details on dosing of the animals, gavage? How were the solutions prepared? Which volumes were given?
- No details on animal housing and actual environmental conditions
- Bone marrow cells are usually obtained from the femurs or tibias immediately following sacrifice. In this study bone marrow from the sternum was used, no justification is provided.
- No details on slide preparation
- Besides statistical analysis no evaluation criteria are mentioned
- The laboratory has no GLP accreditation - GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
- EC Number:
- 217-886-1
- EC Name:
- α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
- Cas Number:
- 1999-85-5
- Molecular formula:
- C12H18O2
- IUPAC Name:
- 2-[3-(2-hydroxypropan-2-yl)phenyl]propan-2-ol
- Details on test material:
- Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Kunming
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co., Ltd. (Certificate No. SCXK 2007-0001)
- Age at study initiation: no data
- Weight at study initiation: 20-30g
- Assigned to test groups randomly: yes, under following basis: no data
- Fasting period before study: NA
- Housing: no details provided
- Diet (e.g. ad libitum): Beijing Keaoxieli Feedstuff Limited Company (Certificate No. SLXK 2009-0012), not clear if it was provided ad libitum
- Water (e.g. ad libitum): Reverse osmosis filtered water, not clear if it was provided ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: 22 June 2011 - 08 July 2011
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data
- Amount of vehicle (if gavage or dermal): no data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: No data
- Duration of treatment / exposure:
- 24 or 48 hours
- Frequency of treatment:
- single administration
- Post exposure period:
- 24 or 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
215, 108, 54 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): from the guideline
- Route of administration: IP
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: No data
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): a single dose was administered and animals were killed 24 and 48 hours after treatment.
DETAILS OF SLIDE PREPARATION: No details, Giemsa staining
METHOD OF ANALYSIS: No details - Evaluation criteria:
- No data
- Statistics:
- χ2 test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Under the test conditions, the test substance does not cause chromosome aberrations in the tested species. - Executive summary:
Interpretation of results: negative
Under the test conditions, the test substance does not cause chromosome aberrations in the tested species.
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