Registration Dossier

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.