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Registration Dossier
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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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The test material is insufficiently characterized in the report, and no analytical purity was given. However, according to " Triclosan supplement I to EU dossier submitted 18 August 2009", the purity of CIBA-produced Triclosan exceeded 99%, and for FAT 80023/A, a degree of purity of 99.3% was reported. The concentration and quantity of triclosan applied to the test site was not provided in the study report. The study design deviates from current guidelines. However, the study results allow the conclusion that triclosan is a skin irritant, and thus, the study is scientifically acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Test
- Principles of method if other than guideline:
- Patch Test as described in the US Association of Food and Drug Officials: "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959)
- GLP compliance:
- no
- Remarks:
- ; GLP was not compulsory at the time the study was conducted
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 80023/A
- Analytical purity: not specified; however, according to " Triclosan supplement I to EU dossier submitted 18 August 2009", the purity of CIBA-produced Triclosan exceeded 99%, and for FAT 80023/A, a degree of purity of 99.3% was reported.
- No further data provided
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): standard rabbit food, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1 °C
- Humidity (%): 55 +/- 5%
- Photoperiod (hrs dark / hrs light): 10 hrs/14 hrs
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, abraded and non-abraded
- Vehicle:
- water
- Controls:
- other: untreated skin areas served for control
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 72 hours after application (i.e. 48 hours after removal of the dressing)
- Number of animals:
- 6
- Details on study design:
- For treatment a gauze patch of 2.5 x 2.5 cm soaked with the test item was applied to the prepared abraded and non abraded skin.
The patches were covered with an impermeable dressing and were fastened to the body of the rabbit with adhesive tape.
The effects on both intact and abraded skin were tested.
The Draize scale (see table below) was used for scoring the skin reactions at 0 and 48 h post exposure; only the findings referring to the intact skin were considered for assessment of the irritant potential of the test item.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (mean value)
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- (mean value)
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- (mean value)
- Basis:
- animal #3
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- (mean value)
- Basis:
- animal #4
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- (mean value)
- Basis:
- animal #5
- Time point:
- other: 24 - 48 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- (mean value)
- Basis:
- animal #6
- Time point:
- other: 24 - 48 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- (mean value)
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- (mean value)
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- (mean value)
- Basis:
- animal #3
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- (mean value)
- Basis:
- animal #4
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- (mean value)
- Basis:
- animal #5
- Time point:
- other: 24 - 48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- (mean value)
- Basis:
- animal #6
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 hours
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