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EC number: 204-320-3 | CAS number: 119-40-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from review article or handbook
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- OPINION ON Triclosan COLIPA n° P32
- Author:
- Scientific Committee on Consumer Products (SCCP)
- Year:
- 2 009
- Bibliographic source:
- European Commission Health & Consumer Protection DG Directorate-SCCP/1192/08-21 January 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Skin sensitization test was conducted in guinea pigs for Triclosan according to Buehler test.
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Not Specified
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
- Test material form:
- other: solid
- Details on test material:
- - Name of test material: Triclosan- Molecular formula: C12H7Cl3O2- Molecular weight: 289.5 g/mol- Substance type: organic - Physical state: solid -InChI: 1S/C12H7Cl3O2/c13-7-1-3-11(9(15)5-7)17-12-4-2-8(14)6-10(12)16/h1-6,16H-Smiles: c1(Oc2c(cc(Cl)cc2)Cl)c(cc(Cl)cc1)O
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% triclosan in a cream/gel
- Concentration / amount:
- 1% triclosan in a cream/gel
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% triclosan in a cream/gel
- Concentration / amount:
- 1% triclosan in a cream/gel
- No. of animals per dose:
- 115: test animals6: control animals
- Details on study design:
- MAIN STUDYA. INDUCTION EXPOSURE- No. of exposures: 9- Exposure period: 5 hours- Test groups:5 animals- Control group:6 animals- Site: backs of animals- Frequency of applications: no data- Duration: no data- Concentrations: 1% triclosan in a cream/gelB. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: 14 to 21 days after induction.- Exposure period: no data- Test groups: 5 animals- Control group: 6 animals- Site: backs of animals- Concentrations: 1% triclosan in a cream/gel- Evaluation (hr after challenge): 24 and 48 hours after the challenge.
- Challenge controls:
- yes concurrent vehicle.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% triclosan in a cream/gel
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- slight irritation (redness) 24 hours after the challenge
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% triclosan in a cream/gel. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: slight irritation (redness) 24 hours after the challenge.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% triclosan in a cream/gel
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- slight irritation (redness) 48 hours after the challenge
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% triclosan in a cream/gel. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: slight irritation (redness) 48 hours after the challenge.
Any other information on results incl. tables
Induction: Slight primary irritation was observed after the first few treatments but was alleviated with regular wash-off procedures.
Challenge: Treated sites showed slight irritation (redness) 24 and 48 hours after the challenge. Previously untreated sites did not show any significant oedema or erythema after challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material Triclosan (CAS No: 3380-34-5) was observed to be not sensitizing on guinea pig skin.
- Executive summary:
The Guinea pig Buehler test was conducted in Hartley (albino) Guinea pigs to assess sensitization potential of test chemical Triclosan (CAS No: 3380-34-5).
The 1% triclosan in a cream/gel was applied dermally (occluded) on back of guinea pigs for both induction and challenge treatment. 5 test and 6 control animals were used. Test sample was applied for 5 hours exposure period during induction. 14 to 21 days after induction, challenge was performed and skin reactions were observed 24 and 48 hours after the challenge.
Slight irritation was observed during the induction period on the test site. The study investigators concluded that no sensitisation was observed, as previously untreated sites did not show any significant oedema or redness following the challenge dose.
Based upon the observations, it is concluded that the test chemical Triclosan (CAS No: 3380-34-5) is not sensitizing to guinea pigs.
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