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Diss Factsheets
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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Established dust limit
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Only worker's exposure is considered as relevant for this substance. Hence, only the dermal and inhalation route are relevant. The inhalation exposure DNEL of 37,026 mg/m3 determined by oral animal NOAEL to human inhalation extrapolation is exceedingly high. This value would not be approached in the workplace because of the physical nature of the chemical, but mainly because 3 mg/m3 dust in air is established as the allowable exposure limit for dusts in the workplace.
We do not expect that the General Poplulation will have direct exposure to triclosan as a raw material because it is only sold to commercial formulators of consumer products. The exposure to cosmetics is covered elsewhere and Triclosan is not marketed into the home care sector.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Triclosan is an active molecule and is only used in regulated markets. The use of triclosan in cosmetics and personal care products is defined according to the cosmetic regulation (1223/2009/EU) and the use concentration is only allowable to a maximum of 0.3%. The use of triclosan in professional applications is supported by the registrant, and is regulated by the Biocidal Products Regulation (528/2012/EU). The relevant use and exposure scenarios for this type of product (Product Type 1) are addressed and so it is not necessary to cover the use and exposure in the CSR.
Other typical consumer products may be surface disinfectants (Product Type 2), which is also regulated by the Biocidal Products Regulation (528/2012/EU) in Europe. The registrant is not supporting the use of Triclosan in this application and so the production volumes are not provided as relevant for this possible exposure.
Within the scope of the REACH regulation text, cosmetic products are referred to as those products, which fall within the definition according to the cosmetics directive (76/768/EEC) and now the cosmetics regulation (1223/2009/EU) as the directive has since been repealed. A cosmetic is defined as ‘any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.’ The term personal care product is not specifically defined either within the REACH legal text or the cosmetic regulation, however, it is generally understood to mean consumer products for use in personal hygiene and beautification. The term ‘cosmetics’ is often used generically as a subgroup of the personal care market.
With reference to Article 14 (5) (b) of the REACH regulation it states that the risk assessment for cosmetic products does not need to be addressed. As written above, the description of what a cosmetic product is, also covers personal care products. Hence, the use of product category (PC) 39 is adequate to cover the use of Triclosan in consumer products. The only relevant REACH market use of Triclosan is the cosmetic market. All other potential uses are either exempt (human medicines use) or classed as already registered (biocidal use). There are no other consumer products to be assessed.
We do not expect that the General Poplulation will have direct exposure to triclosan as a raw material because it is only sold to commercial formulators of consumer products. The exposure to cosmetics is covered elsewhere and Triclosan is not marketed into the home care sector.
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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