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EC number: 609-530-2
CAS number: 38172-91-7
The objective of this study was to provide initial data on the possible
effects of the test item 2 - propyn-1-ol with methyloxirane on
reproductive performance of Wistar rats and the development of pups
consequent to daily oral administration of the test item via gavage at
concentrations of 0, 5, 25 or 125 mg/kg to male and female rats during a
premating period of 2 weeks and during mating (1 week), up to a total of
approximately 4 weeks for males and including gestation and lactation
until postnatal day 4 (PN day 4) for females (up to a total of
approximately 6 weeks).
The 2-propyn-1-ol was homogeneously distributed in the gavage liquids.
Results from content analysis showed slightly higher, but acceptable
concentrations of the gavage liquids as compared to the nominal
Daily clinical observations during the premating, gestation and
lactation period or neurobehavioural observations and motor activity
assessment at the end of the study did not reveal any treatment-related
changes in the animal’s appearance, general condition or
No treatment-related effects were observed in mean body weight, body
weight changes and food consumption in 2-propyn-1-ol compound with
methyl oxirane-exposed animals throughout the study.
No treatment-related effects were observed on mating index, male and
female fertility indices, gestation index, duration of gestation, number
of corpora lutea, implantation sites, lost implantations. No effects
were observed on litter size, pup sex and weight and pup survival.
In males a marked treatment-related increase of kidney weight and liver
weight were observed at the 125 mg/kg bw group, which was accompanied by
a slight increase in alanine aminotransferase activity, bilirubin levels
and bile acids. However, in absence of histopathological changes in the
liver and kidney, these effects are considered treatment-related, but
In females a marked treatement-related increase of kidney weight and
liver weight were observed at the 125 mg/kg bw group. However, in
absence of histopathological changes in the liver and kidney, these
effects are considered treatment-related, but not adverse.
For males the No Observed Adverse Effect Level (NOAEL) for systemic
toxicity is established at the high dose level of 125 mg/kg bw
2-propyn-1-ol compound with methyl oxirane, based on the absence of
adverse effects. Based on the treatment-related related effects observed
on kidney weight and liver weight and parameters, the No Observed Effect
Level (NOEL) for males is established at the low dose of 5 mg/kg bw.
For males the NOAEL for fertility is established at the highest dose of
125 mg/kg bw, because no effects were seen on male fertility.
For females the NOAEL for systemic toxicity is established at the high
dose of 125 mg/kg bw, based on the absendce of adverse effects.
Based on treatment-related effects on liver weight and kidney weight the
No Observed Effect Level (NOEL) for females is established at the mid
dose of 25 mg/kg bw.
For females the NOAEL for fertility and development is established at
the highest dose of 125 mg/kg bw), because no effects were seen on
female fertility and development.
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