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Diss Factsheets
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EC number: 217-121-1 | CAS number: 1745-89-7
- 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
- Type of information:
- other: Assessment report
- Adequacy of study:
- key study
- Study period:
- Assessment was conducted in June 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In accordance with Annex VIII (point 8.8) of Regulation (EC) No 1907/2006 (REACH), a paper-based toxicokinetic assessment has been conducted for the substance, TK 11907. Summaries of studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII, point 8.8 of REACH.
The assessment of the likely toxicokinetic behaviour of the substance was provided to the extent that can be derived from the relevant available information at the time of the assessment. The assessment is based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, November 2012). - GLP compliance:
- no
Test material
- Reference substance name:
- 4,4'-isopropylidenebis[2-allylphenol]
- EC Number:
- 217-121-1
- EC Name:
- 4,4'-isopropylidenebis[2-allylphenol]
- Cas Number:
- 1745-89-7
- Molecular formula:
- C21H24O2
- IUPAC Name:
- 4-{1-[4-hydroxy-3-(prop-2-en-1-yl)phenyl]propyl}-2-(prop-2-en-1-yl)phenol
- Test material form:
- liquid: viscous
- Details on test material:
- - Identification: TK 11907.
-Appearance: Straw coloured viscous liquid.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- Strain:
- other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- Details on test animals or test system and environmental conditions:
- Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
Administration / exposure
- Route of administration:
- other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- Vehicle:
- other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- Details on exposure:
- Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- Duration and frequency of treatment / exposure:
- Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- No. of animals per sex per dose / concentration:
- Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
- Control animals:
- other: Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
Results and discussion
Main ADME results
- Results:
- Not applicable, a paper-based toxicokinetic assessment has been conducted for the substance at the current tonnage level.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The lipophilic nature of the substance (Log Pow 4.12, O'Connor, 2014) would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. Limited absoption may also take place via the skin as the test item was shown to be sensitizer (Henzell, 2014) and the test item could penetrate the dermal membrane through damaged skin.
- Details on distribution in tissues:
- There was evidence of systemic toxicity following the conduct of a repeated dose reproductive screening study in the rat (Fulcher, 2014).
Furthermore the positive response in a sensitization study suggests that the test item nmay bind to carrier proteins in the circulatory systems (Henzell, 2014), thereby facilitating systemic distribution.
- Details on excretion:
- There is no evidence to indicate the route of excretion but low water-soluble products are not favourable for urinary excretion and therefore biliary excretion may be the most plausible route of excretion of the test item via the faeces. Metabolism of the parent material may involve rendering it
more water soluble thereby enhancing renal excretion. The neprotoxicity identified in the reproductive/developmental toxicity screening study (Fulcher, 2014) may therefore have been a consequence of the renal route being a point of excretion.
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- The results of the reproductive/developmental toxicity screening study performed in male and female rats exposed to the test item at dosage up to 750 (reduced to 500) mg/kg bw/day elicited histopathological evidence of abnormal hepatic metabolism, a condition associated with enhanced metabolism, a condition associated with enhanced metbolism. A dditionally, nephrotoxicity was identified at 250 mg/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
The available information suggests that absorption of the test substance would take place from the gastrointestinal tract. Some limited absorption may also be possible through the skin. Once absorbed, the substance would be distributed via circulatory system and the faeces is the most probable route of excretion. - Executive summary:
The available information suggests that absorption of the test substance would take place from the gastrointestinal tract. Some limited absorption may also be possible through the skin. Once absorbed, the substance would be distributed via circulatory system and the faeces is the most probable route of excretion.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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