Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 201-044-5 | CAS number: 77-62-3
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Written assessment
- Type of information:
- other: Written assessment
- Adequacy of study:
- other information
- Study period:
- January 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Written assessment
- Justification for type of information:
- At the current level of registration, a written assessment is suitable.
Data source
Reference
- Reference Type:
- other: Written assessment
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Objective of study:
- other: Written assessment of ADME
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Written assessment based on available study data.
Test material
- Reference substance name:
- 2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
- EC Number:
- 201-044-5
- EC Name:
- 2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
- Cas Number:
- 77-62-3
- Molecular formula:
- C29H40O2
- IUPAC Name:
- 2-{[2-hydroxy-5-methyl-3-(1-methylcyclohexyl)phenyl]methyl}-4-methyl-6-(1-methylcyclohexyl)phenol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name: 2,2’-methylenebis[6-(1-methylcyclohexyl)-p-cresol]
CAS Number: 77-62-3
Batch/Lot number: WWP4J0001
Appearance: White to cream powder
Purity: Considered as 100% (>95%)
Manufacture date: 04 September 2014
Expiry date: 03 September 2018
Storage conditions: Controlled room temperature (15-25 °C, below 70 RH%)
Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- See attached background material below.
- Details on distribution in tissues:
- See attached background material below.
- Details on excretion:
- See attached background material below.
Metabolite characterisation studies
- Details on metabolites:
- See attached background material below.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- See attached background material below.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.
- Executive summary:
In conclusion, there is no evidence that the substance is significantly absorbed via the dermal route or the inhalation route. The results of an oral repeated dose toxicity study indicate that the substance may be absorbed orally. It is likely that the following ingestion, the substance undergoes conjugation with glucuronic acid and sulfate within the gastrointestinal tract. Following absorption, the fatty acids are transported to the tissues of the body including the liver where they undergo oxidation in the cells. These solubilised metabolites are then most probably excreted in the urine in conjugated form. Consequently, the substance is considered to have low bioaccumulation potential.
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