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EC number: 266-028-2
CAS number: 65996-93-2
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
After oral ingestion (feed) of coal tar, the target organs of
tumorigenicity in particular included lung and liver.
Following inhalation, no exposure-related tumours were observed in
organs other than the lung of rats exposed to coal-tar pitch fumes
(aerosol) derived from heated pitch material (750 °C) for 43 or 86
weeks, 17 h/d, 5 d/wk.
Dermal application of tar oils (creosote, a distillation product of coal
tars) for 78 weeks resulted in the development of skin tumours in a dose
related manner. Tumour frequency clearly increased in the dose range of
90 to 800 ng BaP per treatment.
Target organs of tumorigenicity of coal tar after oral ingestion are
various organs distant from the first contact point, in particular lung
and liver, while BaP-induced tumors primarily emerged in tissue of local
Hence, the data indicate significant differences for tumor induction by
coal tar compared to BaP (see Goldstein et al 1998, Tab. 2, see Attached
(1) Both BaP and coal tar induced forestomach tumors in the 2y feeding
BaP, but not coal tar, induced also tumors at two other sites, tongue
Coal tar, but not BaP, induced tumors in lung, small intestine, and
liver, as well as sarcomas, hemagiosarcomas, and histiocytic sarcomas in
[Note: This statement is valid for B6C3F1 mice, since BaP also
induced lung tumors in A/J mice, the most sensitive strain (see
Goldstein et al., Tab. 2, see Attached background material)]
(2) Intraperitoneal single doses of 125, 250, or 375 µg BaP alone
or coal tar containing 3.7 and 14.7 µg BaP induced liver tumors in
infant (15 day old) male B6C3F1 mice, but not in females.
Lower doses of BaP (31.5 or 62.5 µg) administered i.p. alone did not
induce liver tumors.
(3) Tumorigenicity in 15-day male B6C3F1 mice by coal tar could
not be recapitulated by a reconstituted mixture based on component
concentrations. No tumors were found when 125 µg BaP was administered as
part of the reconstituted mixture, even though BaP administered alone at
125 µg/mouse induced tumors.
(4) Ingested coal tar induced lung tumors at high incidence and high
multiplicity in A/J mice.
Also high oral doses of pure BaP resulted in a limited lung tumor yield
in this sensitive strain, but much less as compared to the coal tar
Overall, BaP is at best a weak lung carcinogen when ingested, and
therefore may not be a particularly good surrogate for the use in human
health risk assessments of coal tar.
Table. Number of
tumour bearing animals (papilloma and squamous-cell
carcinoma) following skin treatment with two tar
oils for 78 weeks
p. 28, Tab. 10/11, p. 69-71)
Toluene (solvent control)
CTP 1 [mg]low-BaP
CTP 2 [mg]high BaP
BaP (pos. control)
Oil dose per treatment [mg]
total number of animals
with skin tumours
with malignant tumours
exclusively with benign tumours
tumour type atypical of PAH (cavernous hemangioma), to be considered
after 274 days, therefore: n.e. = not evaluable
Pitch, coal tar, high temp. is classified as carcinogenic Cat. 1B
according to Regulation (EC) No 1272/2008 on classification, labelling
and packaging of substances and mixtures. With Regulation (EU) No
944/2013, harmonised classification is amended to carcinogenic Cat. 1A.
This is based on a comprehensive meta-analysis of epidemiological
studies on workers in respective industrial settings (see EU Risk
Assessment Report for Coal tar pitch, high temperature: EU RAR 323,
2008, Sect. 18.104.22.168.2 and Sect. 22.214.171.124.6). Relevant information is also
summarised in the discussion part of the endpoint summary of IUCLID
Sect. 7 - Toxicological information (derivation of DN(M)EL) or of CSR
Sect. 5.11. - Derivation of DNEL(s) and other hazard conclusions.
Carcinogenicity data are derived from experiments with coal tar
and pitch (fumes).
Tars and pitches constitute a family of products that result from
different distillation steps of coal (condensation products and
distillation residues). Depending on distillation step and distillation
temperature, constituents of the products and their portions are
variable. But major components of all the distillation products and
residues are condensed ring aromatic hydrocarbons in varying composition
(i.e. polynuclear aromatic hydrocarbons). Major toxicological effects of
these products will primarily be caused by the PAH fraction in the
respective substances. Especially for toxicological endpoints that fall
into the toxicological action profile of PAH, it is justified to use
related tars and pitches as supporting substances to characterise
potential effects of pitch, coal tar, high temp.
Justification for selection of carcinogenicity via oral route
Feeding study conducted with coal tar, representative for
constituents of coal-tar pitch. Result refers to coal tar.
Justification for selection of carcinogenicity via inhalation route
Result refers to aerosol of coal-tar pitch (MMAD = 0.5 µm).
Justification for selection of carcinogenicity via dermal route
Dermal oncogenicity study in mice conducted with two coal-tar oils
for 78 weeks: worst case, representative of constituents in pitch
Carcinogenicity: via oral route (target organ): digestive: liver;
Carcinogenicity: via inhalation route (target organ): respiratory:
Carcinogenicity: via dermal route (target organ): other: skin
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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