Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors to Derive a DNEL (Technical report No 110, 2010)
Overall assessment factor (AF):
72
Dose descriptor starting point:
NOAEL
DNEL value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There is no evidence that route-to-route extrapolation cannot be applied. Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal absorption in the absence of evidence of the opposite.

AF for dose response relationship:
1
Justification:
NOAEL in a reliable repeated dose toxicity with reproduction/developmental screening study in rat.
AF for differences in duration of exposure:
6
Justification:
assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
4
Justification:
correction for caloric demand rat to human
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
3
Justification:
according to ECETOC guidance
AF for the quality of the whole database:
1
Justification:
quality of whole database is good
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors to Derive a DNEL (Technical report No 110, 2010)
Overall assessment factor (AF):
30
Dose descriptor:
other: LOAEL
AF for dose response relationship:
10
Justification:
local irritation observed at LOAEL
AF for differences in duration of exposure:
1
Justification:
according to ECETOC guidance
AF for interspecies differences (allometric scaling):
1
Justification:
since the mechanism of skin irritation is considered to be the same in experimental animals and in humans, an interspecies AF of 1 should be applied
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
3
Justification:
according to ECETOC guidance
AF for the quality of the whole database:
1
Justification:
quality of whole database is good
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Vinylene carbonate is positive inin vitromutagenicity tests, whereas anin vivomicronucleus test was negative. Consequently, no definite conclusion concerning mutagenic potential of Vinylene carbonate can be made. A testing proposal for in vivo mutagenicity testing (in vivo Comet assay) is included in the IUCLID file. Until the results of the in vivo mutagenicity study is available, the endpoint genotoxicity is considered inconclusive. Consequently, the DNELs derived in the absence of a definite conclusion on the endpoint genotoxicity are provisional.

Vinylene carbonate is irritating to the eyes. No DNEL for eye irritation will be derived. Appropriate RMM needs to be taken for these effects.

As inhalation absorption is considered negligible, no DNEL inhalation has been derived. (As Vinylene carbonate has a low melting temperature (15°C), the substance is a liquid at ambient temperature, and will be considered as such. The low vapour pressure (335 Pa) and high boiling point (168°C) indicate that the substance will not be available for inhalation as a vapour. For risk assessment purposes, the exposure by inhalation is considered negligible).

 

Acute DNEL’s: generally only for the inhalation route acute DNEL’s are considered relevant, in order to account for peak exposures. Although peak exposure in theory also may occur for the dermal and oral route, these are not normally assessed, so the establishment of acute toxicity DNELs for dermal and oral peak exposures appears superfluous. The long-term DNEL is normally sufficient to ensure that acute effects do not appear. This applies both for systemic and local effects

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors to Derive a DNEL (Technical report No 110, 2010)
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
DNEL value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

There is no evidence that route-to-route extrapolation cannot be applied. Kinetics (metabolism, distribution and excretion) are considered to be similar for oral and dermal absorption in the absence of evidence of the opposite.

AF for dose response relationship:
1
Justification:
NOAEL in a reliable repeated dose toxicity with reproduction/developmental screening study in rat.
AF for differences in duration of exposure:
6
Justification:
assuming chronic exposure of hte general population
AF for interspecies differences (allometric scaling):
4
Justification:
correction for caloric demand rat to human
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
5
Justification:
according to ECETOC guidance
AF for the quality of the whole database:
1
Justification:
quality of whole database is good
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.025 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors to Derive a DNEL (Technical report No 110, 2010)
Overall assessment factor (AF):
50
Dose descriptor:
other: LOAEL
AF for dose response relationship:
10
Justification:
local irritation observed at LOAEL
AF for differences in duration of exposure:
1
Justification:
according to ECETOC guidance
AF for interspecies differences (allometric scaling):
1
Justification:
since the mechanism of skin irritation is considered to be the same in experimental animals and in humans, an interspecies AF of 1 should be applied
AF for other interspecies differences:
1
Justification:
according to ECETOC guidance
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Justification:
quality of whole database is good
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors to Derive a DNEL (Technical report No 110, 2010)
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
DNEL value:
15 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Guidance on Assessment Factors to Derive a DNEL (Technical report No 110, 2010)
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
DNEL value:
15 mg/kg bw/day

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Vinylene carbonate is positive in in vitro mutagenicity tests, whereas an in vivo micronucleus test was negative. Consequently, no definite conclusion concerning mutagenic potential of Vinylene carbonate can be made. A testing proposal for in vivo mutagenicity testing (in vivo Comet assay) is included in the IUCLID file. Until the results of the in vivo mutagenicity study is available, the endpoint genotoxicity is considered inconclusive. Consequently, the DNELs derived in the absence of a definite conclusion on the endpoint genotoxicity are provisional.

Vinylene carbonate is irritating to the eyes. No DNEL for eye irritation will be derived. Appropriate RMM needs to be taken for these effects.

As inhalation absorption is considered negligible, no DNEL inhalation has been derived. (As Vinylene carbonate has a low melting temperature (15°C), the substance is a liquid at ambient temperature, and will be considered as such. The low vapour pressure (335 Pa) and high boiling point (168°C) indicate that the substance will not be available for inhalation as a vapour. For risk assessment purposes, the exposure by inhalation is considered negligible).

 

Acute DNEL’s: generally only for the inhalation route acute DNEL’s are considered relevant, in order to account for peak exposures. Although peak exposure in theory also may occur for the dermal and oral route, these are not normally assessed, so the establishment of acute toxicity DNELs for dermal and oral peak exposures appears superfluous. The long-term DNEL is normally sufficient to ensure that acute effects do not appear. This applies both for systemic and local effects.