The Principles for Assigning the Harmful Agents in the Workplace Environment of Cutaneous Absorption Symbol in Poland
S.M. Czerczak*, M. Kupczewska-Dobecka
Nofer Institute of Occupational Medicine, Lodz, Poland
The Group of Experts for Chemical Agents within the Intersectoral Commission for MAC have been determined the MAC values for harmful agents in Poland and proposes criteria for assigning the Sk symbol (danger of cutaneous absorption).
1. The Group of Experts for Chemical Agents in Poland proposes following principles for assigning the Sk symbol (danger of cutaneous absorption) to polish MAC list of chemicals:
2. All chemicals with LD50s value below 1000 mg/kg should be provided with the Sk index in the MAC list.
3. For other chemicals, a skin notation would be considered when repeated human and dermal application studies have shown significant systemic effects following exposure.
4. When the data quoted above are not available, the physicochemical data are required to calculate the flow: the dermal penetration rate (flux - Fl) (solubility, octanol/water partition coefficient, molecular weight).
Since, two reference values were recommended as the indicators for Skin notation of a chemical in the MAC list:
· dermal absorption potential, which relates to dermal absorption resulting in 30% (1.3‑fold) increase of a non-volatile chemical dose, or of the biological level of a volatile chemical (determined by biological monitoring) relative to the biological levels of that compound resulting from the solely inhalational exposure to the compound at concentration equal to the value specified in the current MAC list;
· dermal toxicity potential, which relates to dermal absorption resulting in 200% (3-fold) increase of the biological levels of the chemical relative to the biological levels of that compound resulting from the solely inhalational exposure to the compound at concentration equal to the value specified in the current MAC list.
The use of LD50 as the criterion for assigning the skin notation in the MAC list reflects Poland’s attempts to fulfil the obligations resulting from the necessity to harmonise Polish regulations with relevant EU law. The Europe Agreement Establishing an Association between Poland and the European Communities and Their Member States (1994) has obliged us to adjust Polish regulations on handing chemicals to those of the EU countries. The criteria of Directive 67/548 specify the following lethal doses to classify chemicals for their skin absorption:
· Very toxic on contact with skin: LD50 after application to skin, rat or rabbit: £ 50 mg/kg.
· Toxic on contact with skin: LD50 after application to skin, rat or rabbit: 50 < DL50 £ 400 mg/kg.
· Harmful on contact with skin: LD50 after application to skin, rat or rabbit: 400 < DL50 £ 2000 mg/kg.
More severe critical lethal doses are used in Poland to assign skin notation to the MAC-list chemical, i.e. all chemicals with LD50 value below 1000 mg/kg should be provided with the Sk index. At the same time we would like to note that LD50 is not the only criterion used to assign the Sk notation to a chemical in he MAC list. A skin notation would be considered when repeated human and dermal application studies have shown significant systemic effects following exposure. Only in some few cases (e.g. for carcinogens or chemicals affecting reproduction) the use of the LD50 criterion to assign a Sk notation may be problematic; for most chemicals with established occupational exposure limits, this may be used with good success. Adopting unequivocal criteria to assign a skin notation to the occupational exposure limits is essential for worker health.
The symbols for assigning the dangerous of cutaneous absorption are not included in the polish law and there are not obligatory. The occupational exposure limit (OEL) list in European Union is published in Commission Directive 2000/39/EC of 8 June 2000 (establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work). The symbols for assigning the dangerous of cutaneous absorption are included in the Directive.
Content last modified: 20 May 2005
