Changes to the 2004 list are marked with an
asterisk (*). In addition, the procedure has also been changed. The
Commission has made its proposals, but is leaving them up for
discussion until 31 December 2005. Until this date, new data or
scientific comments may be submitted to the Commission's office. The
Commission will review the above and, where appropriate, take them
into consideration for their final decision.
This year, two metals deserve particular notice, i.
e. antimony and its inorganic compounds, as well as vanadium and its
inorganic compounds, which were proven to be carcinogenic working
substances in animal experiments. Furan and tetrafluorethylene were
also proven to be carcinogenic in animal experiments and, like the
above-mentioned metals, were assigned to carcinogenicity category 2.
Trinitroglycerol as a suspected carcinogenic
working substance was placed in carcinogenicity category 3B, and the
previous MAK value of 0.05 ml/m³ was suspended until the mechanism of
action has been understood. Aminophene, 1,2 Dichloro-4-nitrobenzene,
ethidium bromide, and 4-Chlorophenyl isocyanate were also assigned to
this category as suspected carcinogens. There were 21 examinations or
new listings for carcinogenic working substances.
In the course of examining suspected carcinogenic
working substances in category 3 regarding a classification in the new
categories 4 and 5, glutardialdehyde and hydrogen peroxide were
reclassified in category 4 with a MAK value of 0.05 and 0.5 ml/m³,
resp. Perfluorooctane acid and its inorganic salts were classified in
this category with a MAK value of 0.005 mg/m³. This year, once again,
no working substances were found for category 5, i. e. carcinogenic
with no noteworthy increased risk at the existing MAK value.
Vanadium and its inorganic compounds are classified
in gamete mutagenicity category 2 due to their mutagenic effect on
gametes. Suspicion of a mutagenic effect of antimony, benomyl, and
carbendazim (category 3A) and of ethidium bromide and propyleneimine (category
3B) on gametes has been substantiated.
The MAK value of perfluorooctane acid and its
inorganic salts was set at 0,005 mg/m³. For 16 substances (acrylic
acid, 2-butene-1,4-diol, N,N-dimethylformamide, 2-ethylhexanol,
fluoride, hydrogen fluoride, d-limonene, methacryl acid, methylic
acetate, N-methyl-2-pyrrolidone (steam), phosphorus pentoxide,
phosphoric acid, m-phthalic acid, p-phthalic acid, tetrahydrothiophene,
and hydrogen peroxide), MAK values changed or new ones were proposed;
the values of five substances (glutardialdehyde, methyl methacrylate,
phosphorus oxychloride, phosphorus pentachloride, and phosphorus
trichloride) were confirmed after thorough reviews of recent
literature. For 13 substances, no MAK values could be determined (benzyl
alcohol, 3,4-Dichloroaniline, 4-Diiodomethylsulfonyltoluene, disulfur
decafluoride (sulfur pentafluoride), gold, fluorine, hydroxyacetic
acid butyl ester, 3-hydroxy-2-naphthalene carboxylic acid, iodine, and
the d,l-limonene isomer compound, 4-isopropyl phenyl isocyanate,
p-chloro-m-cresol, and o-phthalic acid) because of a lack of data.
The re-evaluation of earlier MAK values was
conducted intensively, also in close cooperation with the European (SCOEL)
and the American (TLV) Commissions. It was decided in the course of
this examination to suspend the MAK values of three substances (antimony,
trinitroglycerol, and vanadium pentoxide) because of their suspected
carcinogenicity and of disulphur decafluoride, fluorine, and iodine
because of insufficient data for a health evaluation.
Twenty-two working substances were also examined
with respect to being particularly harmful during pregnancy. Acrylic
acid, fluorides, d-limonenes, methacryl acid, perfluorooctane acid,
phosphor pentachloride, phosphoric acid, and hydrogen peroxide were
assigned to group C which contains those substances for which no
teratogenicity is anticipated if the MAK values are adhered to.
2-ethylhexanol, hydrogen fluoride, glutardialdehyde, methyl acetate,
methyl methacrylate, N-methyl-2-pyrrolidone, and phosphorus pentoxide
remain in this group. By contrast, 2-butine-1,4-diol, phosphorus
trichloride, m-phthalic acid, p-phthalic acid, and tetrahydrothiophene
were assigned to pregnancy group D which essentially states that
classification into group C is not yet possible due to the available
data. A risk of harming the embryo currently appears unlikely if the
MAK values are complied with but cannot be ruled out with sufficient
certainty. Despite new studies, N,N-dimethylformamide remains in Group
B for substances, for which teratogenicity cannot be ruled out even if
the MAK value is not exceeded.
This year, a total of 16 working substances were
examined for their respiratory tract and skin sensitising properties.
New labelling was assigned to eleven chemicals, i. e. benomyl,
bromelain, 2-butene-1,4-diol, tert-butylacrylate, p-chloro-m-cresol,
3,4-Dichloroaniline, farnesol, soluble gold compounds,
methylmethacrylate, 4-isopropyl phenyl isocyanate, sesquiterpene
lactone, and m-xylylenediamine.
A total of 14 substances, among them the
carcinogenic compounds resorcinol diglycidyl ether, furane,
2-nitropropane, perfluorooctane acid, and their inorganic salts,
tetranitromethane, 2,4-Toluylenediamine, 1,2,3-trichloropropane,
vinylcyclohexene, and an N-nitrosamines were newly labelled with the
warning "H", which means that absorption through the skin together
with inhalation may significantly contribute to their toxicity at the
workplace. This warning label was checked and confirmed for
The section BAT values, biological guideline values
and exposure equivalents for carcinogens includes seven changes and
new entries. Exposure equivalents for carcinogenic working substances
have been newly listed for 1,3-butadiene, cyclohexanone, and
1,4-dichlorobenzene, a reduced BAT value for mercury, and BLW for
4-aminobiphenyl, lead (EKA). No BAT values were derived for n-heptane,
methyl-tert-butylether, and molybdenum.