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EC number: 205-289-9
CAS number: 137-32-6
toxicity in vitro
toxicity of the structural analogue pentan-1-ol (CAS No. 71 -41 -0) in
vitro was examined in an Ames test performed by the National Toxicology
Program according to the NTP standard procedure (NTP 1986). The
bacterial strains S. typhimurium TA 1535, TA 1537, TA 98, TA97 and TA
100 were treated with concentrations of 33, 100, 333, 1000, 3333, 6666
and 10000 µg/plate pentan-1-ol with and without metabolic activation by
S9 mix from Aroclor 1254-induced male Sprague-Dawley rat or Syrian
hamster liver. Although cytotoxicity was observed at 6666 and 10000
µg/plate, no mutagenicity was detected.
read across substance branched and linear pentanols (CAS No. 94624 -12
-1) was also not mutagenic in Salmonella typhimurium strain TA98, TA100,
TA1535, TA1537 and TA1538 with or without metabolic (S9) activation in a
study conducted to a method similar to OECD TG 471 (Union Carbide Corp.
1983). The substance was tested at doses of 0.01, 0.03, 0.1, 0.3 and 1
µg /plate. Cytotoxicity was observed at 1 µg/plate with and without S9
mix (Aroclor 1254 induced rat liver homogenate).
& Seidel (2002) performed a mammalian cell gene mutation assay (HPRT)
according to the method described by Bradley et al. (1981) with 2
-methylbutan-1 -ol (CAS No. 137 -32 -6) and the structural analogue 3
-methylbutan-1 -ol (CAS No. 123 -51 -3). Chinese hamster lung
fibroblasts were exposed to both substances with and without metabolic
activation by Aroclor 1254-induced rat liver S9-mix. Even at the highest
concentrations of 51.5 mM and 46 mM tested, no genetic toxicity was
addition, the mutagenic potential of primary amyl alcohol (= pentanol,
branched and linear) was examined in the Chinese Hamster Ovary (CHO)
gene mutation assay (HPRT) according to a method similar to OECD TG 476
(Union Carbide Corp. 1983). The substance did not produce any
dose-related or repeatable statistically significant increases in the
frequency of mutations of CHO cells at concentrations which spanned a
cytotoxic to non-cytotoxic range (0.075, 0.10, 0.15, 0.20 and 0.25 %
v/v) tested with and without an S9 metabolic activation system.
publication by Kreja & Seidel (2002) also includes the results of an in
vitro mammalian cell micronucleus test with Chinese hamster lung
fibroblasts (V79) for pentan-1 -ol, 3 -methylbutan-1 -ol, and 2
-methylbutan-1 -ol. The test was conducted according to the method
described by Miller et al. (1995). Pentan-1-ol was tested for 4 hours at
concentrations of 23 and 46 mM in DMSO with and without metabolic
activation by S9-mix. Since no significant increase of micronuclei was
found after the treatment with pentan-1-ol as opposed to the positive
controls methylmethanesulfonate and cyclophosphamide, pentan-1-ol was
regarded as non clastogenic (Kreja & Seidel 2002). The same test was
conducted with 3-methylbutan-1-ol and 2-methylbutan-1-ol. Both
substances were tested for 4 hours at concentrations of 5, 9 and 23 mM
(3-methylbutan-1-ol) and 23 and 45 mM (2-methylbutan-1-ol) in DMSO with
and without metabolic activation by a S9-mix. Again, no significant
increase of micronuclei was found in both assays.
chromosome aberration assay was conducted with pentanol, branched and
linear according to OECD TG 473 and in compliance with GLP regulations
in primary cultures of lymphocytes obtained from Sprague-Dawley derived
CD ISG (outbred Crl:CD(SD)) rats (Dow Chemical Company 2006).
Approximately 48 hours after the initiation of whole blood cultures,
cells were treated either in the absence or presence of S9 activation
with concentrations of pentanol, branched and linear ranging from 0
(solvent control) to 881.5 µg/mL of culture medium. The highest
concentration was based on the limit dose of 10 mM in this assay system.
The duration of treatment was 4 or 24 hours without S9 and 4 hours with
S9. Based upon the mitotic indices, cultures treated for 4 hours with
targeted concentrations of 0 (solvent control), 220.4, 440.8, and 881.5
µg/mL in the absence and presence of S9 activation and cultures treated
for 24 hours with 0 (solvent control), 110.2, 220.4, and 440.8 µg/mL
were selected for determining the incidence of chromosomal aberrations.
There were no significant increases in the frequencies of cells with
aberrations in either the presence or absence of S9 activation. Cultures
treated with the positive control chemicals had significantly higher
incidences of abnormal cells in all assays. Based upon these results,
primary amyl alcohol-mixed isomer was considered to be non-genotoxic in
this in vitro chromosomal aberration assay utilizing rat lymphocytes.
negative results are confirmed by several additional assays: Pentan-1
-ol was not mutagenic in e.coli in a paper disc assay (Szybalski, 1958).
In another HPRT assay, 3 -methylbutan-1 -ol did not show a mutagenic
potential (Seidel & Plappert, 1999). Neither pentan-1 -ol nor 3
-methylbutan-1 -ol or 2 -methylbutan-1 -ol led to a difference in tail
moment compared to the negative control in a comet assay (Kreja &
Seidel, 2002) (Seidel & Plappert, 1999). No changes were observed with
pentanol, branched and linear in a sister chromosome exchange assay
toxicity in vivo
in vivo results are available for 2 -methylbutan-1 -ol. The genetic
toxicity of 3 -methylbutan-1-ol in vivo was analyzed in a micronucleus
assay performed according to OECD guideline 474. Five male and five
female NMRI mice received a single dose of 1500 mg/kg bw of this read
across substance in 0.25 % aqueous Methocel K4M premium by gavage.
Although the dose of 1500 mg/kg bw was severely toxic in a preceding
range finding test, no mortality occurred. 24 or 48 hours after
administration, the animals were sacrificed and bone marrow was prepared
for analysis. As result, 3-methylbutan-1-ol did not produce a
significant, exposure-related increase in the incidence of
micronucleated polychromatic erythrocytes in male or female animals.
available data are considered reliable and suitable for classification
purposes under Regulation (EC) No 1272/2008 (CLP).No
positive result has been observed in any of the assays. Gene mutation
tests in bacteria were performed with pentan-1 -ol or pentanol, branched
and linear. No gene mutation potential in mammalian cells was confirmed
for 2 -methylbutan-1 -ol, 3 -methylbutan-1 -ol, and pentanol, branched
and linear. Assays for chromosomal abberration exist for all four
category members in vitro and for 3 -methylbutan-1 -ol also in vivo. It
was thus concluded that 2 -methylbutan-1 -ol is not genotoxic to
bacteria or mammalian cells in vitro and also not clastogenic in
mammalian cells in vitro or in vivo.
a result, the substance is not classified for genetic toxicity under
Regulation (EC) No 1272/2008.
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