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EC number: 201-152-2
CAS number: 78-87-5
carcinogenicity studies are available. Two 2-year oral gavage studies,
conducted in rats and mice according to OECD Test Guidelines (TG) 451
were reported (NTP, 1986a). In addition, one 2-year inhalation (whole
body) rat study (Umedaet
2010) was included. No test guidelines are reported for the inhalation
study. All studies were conducted using 1,2-dichloropropane (DCP).
the 2-year oral rat study, no significant or treatment-related increase
in tumour incidence was observed in male rats given 62 or 125 mg/kg
bw/day, while female rats given 125 or 250 mg/kg bw/day showed a
positive trend for mammary adenocarcinoma (incidence rates adjusted for
survival were 3%, 5% and 27% at 0, 125 and 250 mg/kg, respectively).
These tumours consisted of highly cellular fibroadenomas which were not
metastatic, anaplastic, or highly invasive, but were significantly
increased in the high dose group. High dose females showed a marked
decrease in survival and a significant reduction in bodyweight,
indicating that the maximum tolerated dose (MTD) was exceeded.
the 2-year oral mouse study (doses were 0, 125 and 250 mg/kg bw/day for
both sexes) incidences of liver adenoma were increased in high dose
males (45%) and at both doses in females (17 and 19%, respectively).
Control incidences were 20% in males and 3% in females.
increased incidence of thyroid tumours was also observed in females at
the high dose (21% compared with 3% in control, 0% in low dose). Liver
changes (hepatocytomegaly, focal necrosis) occurred in all treatment
groups, which may have affected the metabolic and hormonal state of the
animal. In addition, the concurrent control incidence of hepatocellular
adenomas was lower than the mean historical control incidence while the
highest incidences in the treated mice were below the upper bounds of
the historical control incidence (mean 33%, range 14-58% in males; mean
14%, range 2-28% in females).
the 2-year inhalation rat study (Umeda et al., 2010; concentrations of
0, 80, 200 and 500 ppm (v/v), 50 rats/sex/concentration) there was a
clear increased incidence of nasal papillomas in the highest dose groups
of both sexes. Three cases of olfactory esthesioneuroepitheliomas were
also seen in males exposed to 80 and 200 ppm. Concentration-dependent
increased incidences in hyperplasia of the transitional epithelium and
in squamous cell hyperplasia were also seen in both sexes, as well as
atrophy of the olfactory epithelium, inflammation of the respiratory
epithelium and squamous cell metaplasia.
Body weight and clinical signs
Treated animals showed a dose-related reduction in body weight. Final
body weights were approx. 5% lower than control for low dose animals,
and 14% and 24% lower then control in the high dose male and female
groups, respectively. (Female body weight was decreased by >20% from wk
76 of the study.) No clinical signs are described.
survival of high dose females (250 mg/kg bwt/d) was significantly
(P<0.001) below that of the low dose females and
controls (32%, 86% and 74% survival to the end of the study).
Mortality and morbidity were especially marked at wk 94
of the study. Survival in males was comparable for all groups
(78%, 84% and 82% alive at wk 103 for the control, 62 mg/kg
bwt/d and 125 mg/kg bwt/d groups, respectively).
Because of reduced survival in high dose female rats, statistical
procedures that adjust for intercurrent mortality (life table and
incidental tumor tests) were regarded as more meaningful than the
A quantitative increased tumor incidence in one or both treatment groups
relative to control, or a positive trend in the absence of any
statistically significant difference between the treated and control
groups, was seen for the following tissues and tumor types:
* mammary gland mammary gland hyperplasia was increased, and there was a
positive trend for mammary adenocarcinoma (adjusted rates: 2,7%, 4.7%,
26.7%; significantly increased in high dose group), both in females
only; the overall incidence of fibroadenomas showed a negative trend in
females. Tumor incidence in the high dose group was strongly influenced
by findings in 4 of 16 animals that survived to the end of the study. A
historical incidence of 2% (3/150) was reported for the laboratory
conducting this study, with an overall historical incidence of 1.2%
enometrial stromal polyps occurred with a significant positive trend,
although the incidence in the individual treatment groups was not
increased relative to control.
* thyroid follicluar cell carcinoma were found in two low dose females
(but not in control or high dose females) at study termination; historic
* stomach or forestomach a non-significant increase in squamous cell
papillomas was found in two high dose females (none in control);
historic range 0-0.3%.
* pancreas islet cell carcinomas occurred with a positive trend in
males, however the incidence of adenomas was greatest in the control
group and the combined incidence (adenoma + carcinomas) was not
different between the groups.
* pituitary while the incidence of adenomas was significantly increased
in low dose females, the survival-adjusted incidence was unremarkable;
the incidence of pituitary carcinomas was greatest in control females;
the incidence of combined (adenomas + carcinomas) was not increased
* adrenal glands pheochromocytomas showed a negative trend in males, and
there was no difference in the incidence in combined pheochromocytoma +
No tumors were present in liver, a tissue showing signs of
non-neoplastic changes (see above). Note: Significant increases were
observed in virus antibody titers. The report notes that the
relationship between these increases and occurrence of non-neoplastic-
and neoplastic changes is unclear.
Mean body weights of treated and vehicle control animals were
comparable, and no compound-related clinical signs were noted.
survival of high dose females (250 mg/kg bwt/d) was significantly
(P<0.035) less than that of the low dose females
and controls, with 70%, 58% and 52% of the control, low
and high dose animals surviving to termination. Survival in
males was comparable for all groups (70%, 66% and 70% alive
at wk 103 for the control, 125 mg/kg bwt/d and 250 mg/kg
bwt/d groups, respectively). The report notes that the lowered
survival in female mice was related to an increased incidence
of reproductive tract infections in animals which died
before the end of the study (45% of controls affected versus
64% of both the low and high dose females that died during
Hepatocytomegaly (6%, 10% and 30% for control, low dose and high dose
animals, respectively) and hepatic focal necrosis (4%, 10% and 20%) were
seen in male mice only. Acanthosis of the surface epithelium of the
forestomach occurred at increased incidence in high dose males (0%, 0%,
4%) and both groups of treated females (0%, 10%, 8%). Suppurative
inflammation (affecting ovary, uterus or multiple organs) was found in
5/11 control, 9/14 low dose and 14/22 high dose females that died before
the end of the study.
Tumors were found in the following tissues, although the increase was
not always statistically significant and/or dose-related:
* liver There was a positive trend for liver adenomas in male (20%, 29%,
45%, adjusted for intercurrent mortality) and female (3%, 17%, 19%,
adjusted) mice. Tumor incidences in high dose males (P=0.017, lifetable
test) and both low (0.064, lifetable test) and high dose (P=0.047,
lifetable test) females were increased significantly relative to control.
* thyroid Two high dose females had follicular cell carcinomas, and 3
had follicular cell adenomas. The combined incidence of adenomas or
carcinomas in high dose females (21% adjusted) was increased
significantly (P=0.040, lifetable test) relative to the controls (3%
adjusted), with a historical rate of 1%-3.8%. There were no tumors in
* forestomach Squamous cell papillomas occurred at an incidence of 0%,
2% and 6% in control, low dose and high dose male mice, and at 0%, 4%
and 4% in the equivalent female groups. Historical rates for this tumor
are in the range 0-0.2% for male B6C3F1 mice and 0-0.3% for females. One
high dose female had a squamous cell papilloma (2% incidence, historical
range of 0-0.3%).
* lung Alveolar/bronchiolar adenomas and alveolar/bronchiolar adenomas
or carcinomas (combined) showed a significant negative trend in female
* external surface Subcutaneous fibromas or fibrosarcomas and fibromas
or fibrosarcomas of the skin or subcutaneous tissue occurred with a
significant negative trend in male mice. Note: Significant increases
were observed in virus antibody titers. The reports notes that the
relationship between these increases and occurence of the
non-neoplastic- and neoplastic changes is unclear.
cases of olfactory esthesioneuroepitheliomas were also seen in males
exposed to 80 and 200 ppm. Concentration-dependent increased incidences
in hyperplasia of the transitional epithelium and in squamous cell
hyperplasia were also seen in both sexes, as well as atrophy of the
olfactory epithelium, inflammation of the respiratory epithelium and
squamous cell metaplasia
According to COMMISSION REGULATION (EU) 2016/1179 of 19 July 2016
amending, for the purposes of its adaptation to technical and scientific
progress, Regulation (EC) No 1272/2008 of the European Parliament and of
the Council on classification, labelling and packaging of substances and
mixtures (9th ATP of CLP), 1,2 -dichloropropane is calssified as Carc.
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