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EC number: 701-012-5
CAS number: -
One repeated dose toxicity study according to OECD guideline 422 was
conducted to obtain information on possible effects of the test item
DINCD on general toxicity, reproduction and/or development .
No influence was noted on the fertility and the reproductive parameters
of the parental generation (F0-Generation) with respect to fertility,
pre-coital time, gestation length, gestation index, number of
stillbirths, birth and live birth index and the preand post-implantation
loss for any of the examined dose levels.
The NOAEL for adverse effects on fertility and reproduction parameters
is above the highest administered dose 1000 mg test item/kg b.w./day,
The aim of the study was to obtain information on possible effects of
the test item on general toxicity,
reproduction and/or development according to OECD guideline 422. The
test item Diisononyl 1,4-cyclohexanedicarboxylate (DINCD) was
administered orally to rats at dose levels of 100, 300 or 1000 mg test
In order to investigate the reversibility of potential signs of general
the main study, a toxicity study with a recovery period was additionally
General toxicity - Main study and toxicity study
No premature deaths were noted.
No changes were noted in behaviour, the external appearence or the
condition of the faeces.
The neurological screening, the body weight, the food consumption and the
examined haematological, biochemical and urinary parameters revealed no
item-related differences between the control group and the treatment
The final examinations revealed no test item-related findings during the
macroscopic inspection at necropsy, the examination of the organ
examination of the T4 level and the microscopic examination.
Parantel - Generation
No test item-related influence was noted on the fertility and the
the pre-coital time and the gestation length.
No test item-related influence on prenatal development
number of pups born, number of stillbirths, birth and live birth
indices) were noted
at any of the tested dose levels.
No test item-related influence onpostnatal development(pup
body weight, viability index, the sexual development (ano-genital
distance, male nipples counting), gross abnormalities, T4serum
levels of pups on lactation days 4 and 13 and TSH serum levels of pups
on lactation day 13) was noted at any of the tested dose levels.
The following no-observed-adverse-effect levels (NOAEL) were established:
NOAEL for systemic toxicity above 1000 mg test item/kg b.w./day, p.o.
a) for reproductive parameters of the parental females
NOAEL above 1000 mg test item/kg b.w./day, p.o.
b) for pre- and postnatal development
- b1) adverse effects on prenatal development (conceptus to birth)
- b2) adverse effects on postnatal development (pup)
NOAEL 1000 mg test item/kg b.w./day, p.o.
No classification for reproductive toxicity is indicated according to
the classification, labeling, and packaging (CLP) regulation (EC) No
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