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EC number: 222-182-2 | CAS number: 3380-34-5
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scienitifically acceptable publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Human Exposure to Triclosan via Toothpaste does not change CYP3A4 Activity or Plasma Concentrations of Thyroid Hormones
- Author:
- Allmyr M, Panagiotidis G, Sparve E, Diczfalusy U, Sandborgh-Englund G
- Year:
- 2 009
- Bibliographic source:
- Basic & Clinical Pharmacology & Toxicology, 105: 339–344
Materials and methods
- Type of study / information:
- Clinical human study for investigatation of hormonal and enzyme system changes following in vivo exposure to triclosan.
- Endpoint addressed:
- repeated dose toxicity: oral
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Remarks:
- ; not applicable
Test material
- Reference substance name:
- Triclosan
- EC Number:
- 222-182-2
- EC Name:
- Triclosan
- Cas Number:
- 3380-34-5
- Molecular formula:
- C12H7Cl3O2
- IUPAC Name:
- 5-chloro-2-(2,4-dichlorophenoxy)phenol
- Details on test material:
- Toothpaste containing 0.3% (w/w) triclosan
Constituent 1
Method
- Ethical approval:
- other: The study was approved by the ethics committee at Karolinska Institute, Huddinge, Sweden; Dnr 2008 ⁄ 615-31.
- Details on study design:
- Twelve healthy adults, five men and seven women, were recruited for the study; the participants were employees or students at Karolinska Institute, Huddinge, Sweden and written informed consent was mandatory for participation in the study.
The participants were considered healthy by standard physical examination and routine laboratory tests. Exclusion criteria were ongoing or within the previous 2 months ended medication, use of prescription free drugs (e.g. St John’s wort), and positive test for pregnancy. The half-life for triclosan in plasma is 19 hr and the authors had previously shown that plasma concentrations return to baseline levels within 8 days after exposure to triclosan. Hence, the participants admitted to set out any personal triclosan-containing products 2 weeks before and during the experimental exposure to triclosan toothpaste. In addition, the intake of any products containing grapefruit, which is known to inhibit CYP3A4 activity, was avoided. - Exposure assessment:
- measured
- Details on exposure:
- EXPOSURE
The participants were instructed to brush their teeth for 3 minutes with a 2 cm strain of a toothpaste containing0.3% (w w) triclosan twice a day (morning and evening) for 14 days. These criteria were estimated, and selected with the objective to reflect an upper range of exposure to triclosan via toothpaste that may be expected in a normal human population. No toothpaste was to be swallowed on purpose. For compliance control, the participants logged the time for each occasion they brushed their teeth.
SAMPLING
The blood samples were collected at the Karolinska University Hospital, Huddinge, Sweden. One blood sample was collected from each participant at two occasions; one the day before the start of exposure and one the day after the end of exposure. Blood was centrifuged and the plasma was transferred to polypropylene tubes for storage at- 20°C immediately after sampling until analysis.
SAMPLE ANALYSIS
After sample hydrolysis, triclosan was determined as the sum of triclosan present in unconjugated and conjugated form. Triclosan was analysed using liquid-liquid extraction. An isotope dilution method with 13C-labelled triclosan as the internal standard was applied for quantification, using gas chromatography ⁄ electron capture negative ionisation ⁄mass spectrometry (Allmyr et al., Anal Chem 78:6542–6546, 2006).
4ß-Hydroxycholesterol was determined by isotope dilution gas chromatography-mass spectrometry using a deuterium-labelled internal standard.
Thyroid hormones (FT3, FT4 and TSH) were determined by commercial electrochemiluminescence immunoassays (Roche Diagnostics GmbH, Mannheim,Germany).
Results and discussion
- Results:
- Triclosan in plasma:
The triclosan concentrations were above the limit of quantification in all analysed plasma samples. The plasma triclosan concentrations were significantly higher after than before the 14 days of exposure to triclosan containing toothpaste. Before exposure, the triclosan concentrations ranged from 0.009 to 0.81 ng ⁄ g whereas after exposure, the concentrations ranged from 26 to 296 ng ⁄ g; the difference was statistically significant (one-tailed paired t-test; p = 0.003).
4ß-Hydroxycholesterol, thyroid-stimulating hormone, free thyroxine and free tri-iodothyronine in plasma:
There were no significant differences in plasma concentrations before and after the exposure to triclosan contained in toothpaste for any of the analysed variables. FT3, FT4 and TSH concentrations were all within the reference interval (FT3: 3.0–6.5 pmol ⁄ l; FT4: 12–23 pmol ⁄ l; TSH: 0.4–4.7 mE/l).
Applicant's summary and conclusion
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