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The system of establishing MAC values in Poland

DEFINITIONS DEFINITIONS

NDS – MAC (TWA): MAXIMUM ADMISSIBLE CONCENTRATION: the time-weighted average concentration for a conventional 8-hour workday and a workweek defined in the Labour Code, to which workers may be exposed during their whole working life, without any adverse effects on their health (also when retired) or that of the next generations.

NDSCh – MAC (STEL): MAXIMUM ADMISSIBLE SHORT-TERM CONCENTRATION:the short-term exposure limit is an average concentration, to which workers may exposed without any adverse health effects if it does not last longer than 15 minutes and does not occur more than twice during a workday, at intervals not shorter than 1 hour.

NDS – MAC (C): MAXIMUM ADMISSIBLE CEILING CONCENTRATION: Ceiling concentration, which because of the threat to workers’ health or life, should not be exceeded even instantaneously

DOCUMENTATION DOCUMENTATION

Contents Summary

Substance characterisation, uses and occupational exposure Toxic effects on human

Toxic effects on laboratory animals

Carcinogenicity, mutagenicity, teratogenicity, embriotoxicity, and effects on reproduction

Toxicokinetics Mechanism of toxicity Combined effects

Dose-effect and dose-response relationships

Bases of existing MAC or MAI values and biological tolerance limits Bases for proposed MAC or MAI values and biological tolerance limits

Methods of determining the agents harmful to health in the air and in biological material

Pre-employment and periodical medical examinations References

The documentation are published quarterly in the publication of the Interdepartmental Commission “Principles and Methods of Assessing the Working Environment”

Jolanta SKOWROŃ Ph. D., Małgorzata POŚNIAK Ph. D.

Central Institute for Labour Protection – National Research Institute (CIOP-PIB), Czerniakowska 16, 00-701 Warsaw, Poland.

Calculation of MAC value for chemical substances MAC = NOAEL or LOAEL/UF

UF is calculated from the formula:

UF = A x B x C x D x E

FACTOR EXTRAPOLATION

A = max. 3 intraspecies

B = max. 10 interspecies and route-to-route extrapolation

= max. 3 for tests using inhalation exposure C = max. 3 short term to long-term exposure D = max. 3 LOAEL to NOAEL

E = max. 5 incompletness of data

Xylene [1330-20-7]

MAC MAC-STEL Notation

Europe 50 ppm /221 mg/m³ 100 ppm /442 mg/m³ Skin

Austria 50 ppm /221 mg/m³ 100 ppm /442 mg/m³ H (Skin) Belgium 50 ppm /221 mg/m³ 100 ppm /441 mg/m³ D (Skin)

Cyprus 100 ppm /441 mg/m³

(Value for 108-38-3)

50 ppm /221 mg/m³

δερµα (Skin)

Czech Republic 200 mg/m³ 400 mg/m³ D (skin)

Denmark 25 ppm /109 mg/m³ H (Skin) (for all isomers)

Estonia 50 ppm /200 mg/m³ 100 ppm / 450 mg/m³ A (Skin)

France 50 ppm /200 mg/m³ 100 ppm / 442 mg/m³

Finland 50 ppm /220 mg/m³ 100 ppm / 440 mg/m³ ‘Iho’ (Skin) 200 ppm / 880 mg/m³ H (Skin) (15 minutes) Germany 100 ppm/440 mg/m³

DFG (Scientific Source) Greece 100 ppm/435 mg/m³ 150 ppm / 650 mg/m³ ∆ (Skin) (15 minutes)

Hungary 221 mg/m³ 442 mg/m³ B

Ireland 50 ppm /221 mg/m³ 100 ppm / 442 mg/m³ Sk (Skin) Italy 50 ppm /221 mg/m³ 100 ppm /442 mg/m³ Pelle (Skin)

Latvia 50 ppm /221 mg/m³ 100 ppm / 442 mg/m³ Ada

Lithuania 100 ppm / 442 mg/m³

(3 sep. isomers)

50 ppm /221 mg/m³

O (Skin) Luxembourg 50 ppm /221 mg/m³ 100 ppm / 442 mg/m³ Peau (Skin)

Netherlands 210 mg/m³ 442 mg/m³ H (Skin)

Malta 50 ppm /220 mg/m³ 100 ppm / 441 mg/m³ H (?) Poland 100 mg/m³ 350 mg/m³ I – irritation, Ft – fetotoxicity

Portugal 50 ppm /221 mg/m³ 100 ppm / 442 mg/m³ -

Slovakia 50 ppm /221 mg/m³ 442 mg/m³ K (skin)

Slovenia 50 ppm /221 mg/m³ 100 ppm / 442 mg/m³ K (skin), BAT (biological limit) Spain 50 ppm /221 mg/m³ 100 ppm / 442 mg/m³ Skin, VLB, VLI

100 ppm / 450 mg/m³

Sweden 50 ppm/200 mg/m³ H (Skin)

UK 50 ppm /221 mg/m³ 100 ppm / 441 mg/m³ Sk (Skin), BMGV (Biol.

Mon. Guidance Value) Prime Minister

Minister of Labour

and Social Policy Minister of Health

Interdepartmental Commission for Maximum

Admissible Concentrations and Intensities for Agents Harmful to Health in the

Working Environment Expert Group

for Chemical and Dust Agents

Expert Group for Physical Factors

Expert Group for Biological Agents

Industry, employees, employers, social partners

The organization diagram of establishing system MAC and MAI values in Poland

Example

2-METHYLNAPHTHALENE

The Expert Group has established 25 mg/m³ as the maximum exposure concentration (MAC) for 2-methylnaphthalene based on the experiment on mice fed diets containing 2-MN for 81 weeks. The dose of 87.5 mg/kg was established as the lowest-observed-adverse-effect level (LOAEL), which was then re-calculated for humans.

Dh= Dw ·Wh/ Vh where:

Dh = the dose of substance absorbed by the animal extrapolation to humans Dw= the dose of substance gave to animal per os

Wh= mean weight of the human (70 kg)

Vh= value of the air inhalation by the human during 8 hours (10 m3) Dh= (87.5 mg/kg · 70 kg) / 10 m3= 612.5 mg/m3

UF is calculated from the formula:

A= 2, average human to sensitive human (the different activity of enzyme glucose-6-phosphate dehydrogenase in human)

B= 2, for tests using exposures other than inhalation C= 1, long-term exposure (81 weeks)

D= 2, LOAEL to NOAEL

E= 3, modifying factor related to small amount of data on working exposure and other toxic effects

MAC = 612.5 mg/m3/ (2 · 2 · 1 ·3) = 25.5 mg/m3

Due to the irritant effect, the MAC-STEL value was established at the level of 50 mg/m³. The Group has suggested an additional determination with letters

“I” (irritation) and “Sk” (skin).

203 223

261 369

433 441

498 514

132

710 690

0 100 200 300 400 500 600 700 800

The number of chemical substances and dusts harmful to health

1985 1990 1995 2001 2002 2004 2005 2007 EU USA

(ACGIH) Germany Maximum admissible concentrations of harmful to health chemical agents and dusts in the

working environment in Poland, USA and Germany

The number of chemical substances, for which were established Occupational Exposure Levels (OELV) 2000/39/CE), 2006/15/CE) 10 binding OEL acc. to Dir.

98/24, 99/238 and 2003/18.

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