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Effects on fertility

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

 Reproduction 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.

The NOAEL for reproduction was established to be 50 mg/kg bw/day, based on reduced number of live pups and reduced number of implantation sites in high dose females. Based on observed deficiencies in maternal care in mid- and high- dose females, the NOAEL for breeding was set at 15 mg/kg bw/day.

Short description of key information:

A reliable repeated dose toxicity study with reproduction/developmental toxicity screening test according to OECD 422 is available.

Justification for selection of Effect on fertility via oral route:

reliable reproduction/developmental toxicity screening study available

Justification for selection of Effect on fertility via inhalation route:

The test substance has a boiling point above 150 ºC (168 ºC) and a low vapour pressure (335 Pa). According to REACH Guidance R14, the volatility band is low. As the melting point is  15ºC, the substance will be a liquid in most operating conditions. Based on this, it is deemed acceptable to waive the reproduction toxicity test by the inhalation route. Besides, sufficient data are available to address reproduction toxicity via oral exposure, and therefore no testing is required for toxicity via the inhalation route according to column 2 of Annex VIII of (EC) Regulation No 1907/2006.

Justification for selection of Effect on fertility via dermal route:

Since reliable data are available to address reproduction toxicity via oral exposure, no testing is required for toxicity via the dermal route according to column 2 of Annex VIII of (EC) Regulation No 1907/2006.

Effects on developmental toxicity

Description of key information

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

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
good
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

Developmental 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 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.

In the absence of effects on pups, The NOAEL for developmental toxicity was established to be at least 150 mg/kg bw/day.

Justification for selection of Effect on developmental toxicity: via oral route:

reliable reproduction/developmental toxicity screening study available

Justification for selection of Effect on developmental toxicity: via inhalation route:

The test substance has a boiling point above 150 ºC (168 ºC) and a low vapour pressure (335 Pa). According to REACH Guidance R14, the volatility band is low. As the melting point is  15ºC, the substance will be a liquid in most operating conditions. Based on this, it is deemed acceptable to waive the reproduction toxicity test by the inhalation route. Besides, sufficient data are available to address reproduction toxicity via oral exposure, and therefore no testing is required for toxicity via the inhalation route according to column 2 of Annex VIII of (EC) Regulation No 1907/2006.

Justification for selection of Effect on developmental toxicity: via dermal route:

Since reliable data are available to address reproduction toxicity via oral exposure, no testing is required for toxicity via the dermal route according to column 2 of Annex VIII of (EC) Regulation No 1907/2006.

Justification for classification or non-classification

In a combined repeated dose toxicity study with reproduction/developmental toxicity screening according to OECD 422, effects on reproduction and maternal care were observed at dose levels at which significant parental toxicity was observed. No effects on pups was observed. Based on these observations, Vinylene carbonate needs not to be calssified as reproduction toxicant according to:

-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.