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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Version / remarks:
- (dated 1984)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
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:
- - Name of test material (as cited in study report): FAT 80'023/Q
- Physical state: white solid
- Analytical purity: not specified in the study report; however, according to " Triclosan supplement I to EU dossier submitted 18 August 2009", the purity of CIBA-produced Triclosan exceeded 99%, and for FAT 80’023/Q, Batch No. EN 91390.76 a purity of 99.6% was reported.
- Lot/batch No.: EN 91390.76
- Expiration date of the lot/batch: November 1992
- Stability under test conditions: stable for at least 24 months
- Stability in solvent: stable for at least 48 h in ethanol, DMSO, DMF and hexane.
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO med. Versuchstierzuchten GmbH, Kißlegg, Germany
- Age at study initiation: at least 7 weeks old
- Weight at study initiation: 140-160 g
- Assigned to test groups randomly: yes
- Housing: single, in Makrolon Type I cages, with wire mesh top.
- Fasting: Approximately 18 hours before treatment with the test article the animals received no food but water ad libitum
- Diet (e.g. ad libitum): pelleted standard diet (ALTROMIN 1324)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hrs/ 12 hrs
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 1% aqueous carboxymethylcellulose
- Details on exposure:
- The test article was suspended in 1% carboxymethylcellulose. The volume administered orally was 10 mL/kg bw.
- Duration of treatment / exposure:
- 6 h, 24 h and 48 h after a single administration of the test article the animals were sacrificed for bone marrow cells removal.
- Frequency of treatment:
- Single administration
- Post exposure period:
- see duration of treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- Sex animals/sex/group
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Cyclophosphamide, 20 mg/kg bw (in deionised water) was used as positive control substance.
Examinations
- Tissues and cell types examined:
- Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of cytogenetic damage. Per animal, 50 well spread metaphases were scored for gaps, breaks, fragments, deletions, exchanges and chromosomal disintegrations.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION
The dose for the cytogenetic assay was determined in a pre-experiment for toxicity. 4000 mg/kg bw was the maximum tolerated dose (MTD).
TREATMENT AND SAMPLING TIMES
After 6 h, 24 h and 48 h following the single administration of the test article, the animals were sacrificed and the the bone marrow cells were collected for chromosome aberration analysis.
DETAILS OF SLIDE PREPARATION
The femora were removed, the epiphyses were cut off and the marrow was flushed out for collection of a cell suspension which was then incubated (20 min, 37°C). Following centrifugation and removal of the supernatant, the cell pellet was fixed (3:1 absolute methanol in glacial acetic acid fixative), gently resuspended and stored overnight at 4°C. Prior to making slides the fixative was changed and enough fixative was added to make a relatively thin cell suspension. The fixative-cell suspension was spread by flame-drying and stained with Giemsa solution. Cover slips were mounted with Eukitt. At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS
Evaluation of the slides was performed microscopically. Gaps, breaks, fragments, deletions, exchanges and chromosomal disintegrations were recorded as structural chromosome aberrations. At least 50 weIl-spread metaphases per animaI were scored for cytogenetic damage on coded slides. Only metaphases with the characteristic chromosome number of 42 were included in the analysis. To describe a cytotoxic effect the mitotic index (% cells in mitosis; 1000 cells were scored) was determined. Five animals per sex and group were evaluated as described. The remaining animal of each test group was evaluated in case an animal died in its test group spontaneously or due to gavage error. - Evaluation criteria:
- A test article is classified as mutagenic if it induces either a statistically significant dose-related increase in the number of structural chromosomal aberrations or a reproducible statistically significant positive response for at least one of the test points.
A test article producing neither a statistically significant dose-related increase in the number of structural chromosomal aberration nor a statistically significant and reproducible positive response at anyone of the test points is considered non-mutagenic in this system.
However, both biological and statistical significance should be considered together. - Statistics:
- Statistical significance at the five per cent level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- At no preparation interval the chromosome aberration frequency was significantly enhanced as compared to the negative control.
- Toxicity:
- no effects
- Remarks:
- The mitotic index in the preparations was not affected by the test substance.
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRETEST
In the preliminary toxicity experiment, 4 animals per dose received 5000 or 4000 mg triclosan /kg bw peroral. At 5000 mg/kg bw, one male rat died after 48 h post dose. Apathy and reduction of spontaneous activity were observed. No mortality was observed in rats treated with 4000 mg/kg bw. Reduction of spontaneous activity was observed in some animals until 6 h post treatment. Thus, 4000 mg/kg bw was defined as the maximum tolerated dose (MTD) and was selected as test dose for the genotoxicity assay.
MAIN ASSAY
At no preparation interval the chromosome aberration frequency was significantly enhanced as compared to the negative control.
An appropriate reference mutagen was used as positive control and showed a distinct increase of induced aberration frequency.
Applicant's summary and conclusion
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