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Description of key information

A reliable oral repeated dose toxicity with reproduction/developmental toxicity screening study in rat is available.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
15 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
good

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity of vinylene carbonate was studied in rats in dosed by oral gavage to 0, 15, 50 or 150 mg/kg bw/day for a minimum of 28 days in a combined repeated dose toxicity study with reproduction/developmental screening test according to OECD 422.

At 15 mg/kg bw/day the observed incidental salivation in a few animals and piloerection during a short period after dosing were not accompanied by other effects in this group. In the absence of other effects, these observations are considered not adverse/toxicological relevant.

At 50 mg/kg bw/day, animals showed clinical signs, increased liver weight (m), microscopic changes in liver (m), stomach (f) and thymus (f), and deficiencies in maternal care.

At 150 mg/kg bw/day, animals showed clinical signs, decreased body weight (gain), several haematological and clinical biochemistry changes, stomach and liver abnormalities at macroscopic examination, increased liver and kidney weights, microscopic changes in liver, stomach, thymus, spleen, mesenteric lymph nodes (m/f) and mandibular lymph nodes (m). High dose females showed a reduced number of living pups, a reduced number of implantation sites and deficiencies in maternal care.

Based on the observed effects in mid and high dose animals, the parental NOAEL was established to be 15 mg/kg bw/day.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:

reliable study on repeated dose toxicity

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

waiver for not performing an inhalation repeated dose  toxicity study

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:

waiver for not performing a dermal repeated dose  toxicity study

Justification for classification or non-classification

In the absence on more information on time-dependent dose effects of Vinylene carbonate, Category 2 for the oral route is proposed, since within the guidance values of 10 < concentration ≤ 100 mg/kg bw/day in a combined repeated dose toxicity study with reproduction/developmental screening effects on liver (increased liver weight and liver cell necrosis in 2/6 males) were observed in males exposed for 28 days, whereas these effects in females exposed for 44 days were observed at a higher dose. Also the more severe effects seen at 150 mg/kg bw/day (males and females) are within the range of guidance values as given for a 28-day repeated dose toxicity study. In addition, the effect levels (50/150 mg/kg bw/d) are outside the range for a Category 1 classification (90-day: concentration ≤ 10 mg/kg bw/d; 28-day: concentration ≤ 30 mg/kg bw/d).

Based on the data available, VC needs to be classified as `STOT RE Category 2` with Hazard Statement H373 according to the:

-Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2011),

-Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.