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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Treatment-related toxic effects in the testes and epididymides were observed at 450 mg/kg bw/day. The testicular changes consisted of a decrease in testes weight, a flaccid appearance at macroscopic examination and histopathological changes. The latter changes occurred in all males treated at 450 mg/kg bw/day and were characterized by germ cell degeneration, germ cell depletion, the presence of multinucleated giant cells and abnormal spermatogenic staging profiles. Changes in the epididymides consisted of the presence of cell debris and a marked reduction of the amount of sperm in this organ.

No treatment-related changes were noted in any of the remaining reproductive parameters investigated in this study (i.e. mating, fertility and conception indices, precoital time, and numbers of corpora lutea and implantation sites, and histopathological examination of female reproductive organs).

In conclusion, treatment with 1,3-divinylimidazolidin-2-one by oral gavage in male and female WistarHan rats revealed parental toxicity at 150 and 450 mg/kg bw/day. Adverse parental effects at 450mg/kg bw/day included clinical signs, reduced body weight and food consumption, signs of anaemia changes in clinical biochemistry parameters and changes in thyroid hormones, thyroid weight and

thyroid morphology. Effects on body weight and thyroid (hormones and morphology) were also noted at 150 mg/kg bw/day. Treatment-related toxic effects in the testes and epididymides were observed in males at 450 mg/kg bw/day and consisted of reduced testes weight and histopathological changes in the testes and epididymides.


Short description of key information:
OECD 422: NOAEL 150 mg/kg bw/day

Justification for selection of Effect on fertility via oral route:
Only one study available

Effects on developmental toxicity

Description of key information
OECD 422 NOAEL: at least 450 mg/kg bw/day
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
450 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No developmental toxicity was observed up to the highest dose level tested (450 mg/kg bw/day).

No toxicologically significant changes were noted in any of the developmental parameters investigated (i.e. gestation index and duration, parturition, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight and macroscopy).

Justification for classification or non-classification

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified for reproductive toxicity cat. 2 (H361f) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

 

Additional information