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EC number: 284-892-9
CAS number: 84989-04-8
The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
In several tests performed according to OECD TG 471 in the
presence and in the absence of a metabolic activation system and tested
up to cytotoxicity the componens o-, m- and p-cresol revealed no
genotoxic activity when tested from concentrations of 5 to 5000 µg/plate
(Pepper, Hamilton & Scheetz 1981, Pool and Lin 1982, Pool 1992, Haworth
1993, JETOC 1998 and MHLW 2001). All cresols had been tested with the
Salmonella typhimurium strains recommended in the guideline TA98, TA100,
TA1535, TA1537 and TA1538. Additionally m-cresol was tested with the
recommended Escherichia coli WP2uvrA and WP2uvrA/pKM101strains to cover
the detection of certain oxidising mutagens, cross-linking agents and
hydrazines as well (JETOC 1998).
The results from the tests are confirmed by the negative results
in the mouse lymphoma assays performed according to the respective
guideline with and without a metabolic activation system on all three
components (Pepper, Hamilton & Scheetz 1981, CMA 1988).
In contrast to that the tests for chromosome aberration in
mammalian cell systems in the presence and in the absence of a metabolic
activation revealed clastogenic activity for cresols when tested up to
cytotoxicity. (CMA 1988, MLHW 2001).
An in-vivo chromosomal aberration assay with m-cresol in mice bone
marrow following oral dosing of 96-960 mg/kg bw yielded a negative
result. The doses were chosen from dose-range finding study with
400-2000 mg/kg bw resulting in mortality (0/6-6/6) and difficulty in
breathing and lethargy (CMA 1989). However, the reliability of the test
result is questionable because of experimental deficiencies (only 50
instead of 100 metaphases were scored). Thus, this assay cannot fully
compensate the result from the in-vitro assays.
Additionally performed reliable in-vivo studies generally showed
negative results for cresols. The Dominant Lethal Assay (DLA) with
o-cresol in the mouse was negative (CMA 1989). When tested according to
OECD TG 478 /Rodent Dominant Lethal Assay) p-cresol did also
not induce dominant lethal mutations in male germ cells of mice (CMA
1989). Following repeated dosing of mice with 0 and 1250-20000 ppm for
13 weeks a MNT with peripheral erythrocytes in mice that were dosed with
0, 5000, 10000 and 20000 ppm was carried out. The NOAEL for general
toxicity is 1250 ppm based on increased relative kidney and liver
weights at higher doses. In the erythrocytes of the chosen mice o-cresol
did not induce a significant elevation in the frequency of
micronucleated erythrocytes. (US Department of Health and Human Services
Thus, cresols reveal no gene mutation activity and the clastogenic
activity in vitro was not confirmed by respective in vivo studies.
The in vivo tests disproved the positive result from the in vitro
chromosome aberration assays. Therefore cresols have not to be
classified for mutagenic potential.
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