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EC number: 205-289-9
CAS number: 137-32-6
There are no indications of a carcinogenic potential from the available in vitro and in vivo genotoxicity and repeated dose toxicity study results. No carcinogenic potential was revealed for the category member pentan-1-ol in a 24 week pulmonary tumor screening assay performed using intraperitoneal injections in mice.
The available data are considered reliable
and suitable for classification purposes under Regulation (EC) No
As a result, the substance is not classified
for carcinogenicity under Regulation (EC) No 1272/2008, as amended for
the seventh time in Regulation No (EC) 1297/2014.
Based on reliable in vitro and in vivo
genetic toxicity tests with 2-methylbutan-1-ol and its structural
analogues, these substances are not considered to be genotoxic. In
addition, there is no indication from repeated dose studies that the
substances are able to induce hyperplasia or pre-neoplastic lesions.
Thus, there is not concern regarding carcinogenicity for these
No adequate experimental animal data
according to or equivalent to the OECD guidelines 451/452/453 are
available and no epidemiological studies investigating the
carcinogenicity of 2-methybutan-1-ol or its structural analogues were
identified. However, carcinogenicity of the read-across substance
pentan-1-ol was investigated in a 24 week pulmonary tumor assay, where
30 female A/He mice per dose received 24 intraperitoneal injections of
50 or 250 mg/kg bw pentan-1-ol over 8 weeks. Thereby, survival, body
weights and results from gross pathological and histological
examinations of the lungs were assessed. 24 weeks after the start of
dosing, animals were sacrificed and liver, kidney, spleen, thymus,
intestine and salivary and endocrine glands were examined for
abnormalities at necropsy. Positive control groups consisting of animals
treated with 2 dose levels of urethane (10 or 20 mg urethane/animal)
were also maintained. An untreated control group of 50 mice per sex was
included. Data on untreated animals represent the spontaneous lung tumor
incidence in A/He mice and according to the authors, were in close
accord with earlier data on mice of equivalent age. Positive controls
treated with urethane showed a dose-related increase in pulmonary tumor
incidence. The result of this study was clearly negative, as the lung
tumor rate was found to be lower in pentan-1-ol treated groups as
compared to the untreated control group (3 % in treated versus 17 % in
untreated mice). Thus, under the conditions of this study, pentan-1-ol
did not show any carcinogenic potential.
2 -methylbutan-1 -ol (CAS No. 123 -51 -3) was
evaluated in an invalid and badly documented carcinogenicity study which
was described in two publications (Gibel et al. 1974, 1975). In these
studies, 19 Wistar rats were dosed orally twice a week with 0.2 mL/kg bw
2-methylbutan-1-ol corresponding to 163 mg/kg bw/dose whereas 24 animals
received an subcutaneous injection of 0.05 mL/kg bw corresponding to
40.8 mg/kg bw/dose twice a week. The number of control animals was
inconsistently reported as either 25 or 30. Postmortal examination after
the average life time of 495 (oral) and 544 (s.c.) days included blood
analysis as well as histopathological analysis of the organs, spinal
segments and femurs. Severe chronic-toxic effects were reported. These
were liver cirrhosis, myocard necrosis and effects on pancreas and
haematopoietic organs. However, the number of affected animals was not
given, nor could the effects be assigned to a specific dose group. The
effects are especially surprising since no adverse effects were observed
in two studies after daily treatment with a more than 10 times higher
dose for 90 days, which leads to a higher cumulative dose (108 -119g/kg
compared to 23g/kg p. o. and 6.3g/kg s. c.) in a much shorter time
period. No tumours were seen in the control rats after two years, which
is unlikely even considering the relatively low number of animals used.
No historical control data were provided. A low overall number of
tumours occured in the treated groups (3 after oral treatment, 8 after
s.c. treatment) as single incidences of different tumour types in
different organs, which are considered incidental. Due to severe
deficits the study was disregarded for the assessment.
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