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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
187.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

No reliable data were available from a repeated dose toxicity study with ethylene carbonate via the inhalation route. However, as the substance is rapidly metabolised to ethylene glycol after oral exposure to ethylene carbonate (Hanley et al., 1989 and Ehmer et al., 2015), reliable data from that metabolite are used for the risk characterization of ethylene carbonate (further information on the justification of the proposed read-across can be found in Section 13).

Therefore, the NOAEL of a chronic oral toxicity study in rats with ethylene glycol, set at 150 mg/kg bw/day as nephrotoxicity occurred at 300 and 400 mg/kg bw/day (Corley et al, 2008), is selected to derive the DNEL long-term systemic effects via the inhalation route for workers as it is the most sensitive endpoint/lowest NOAEL value. Considering the higher molecular mass of ethylene carbonate in contrast to ethylene glycol (88.06 vs 62.07 g/mol), a NOAEL of 150 mg/kg bw/day of ethylene glycol corresponds to 212.9 mg/kg bw/day for ethylene carbonate. This recalculated NOAEL is used to derive the DNEL long-term systemic effects via the inhalation route for workers.

For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point is 187.7 mg/m³ = (212.9 mg/kg bw/day x 1/(0.38 m³/kg bw/day) x 6.7 m³/10 m³ x 0.5). The NOAEL needed to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while after oral exposure this is only 50%.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point
AF for differences in duration of exposure:
1
Justification:
chronic study (1 year, oral, feed)
AF for interspecies differences (allometric scaling):
1
Justification:
no value as it is included in the route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
4.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
212.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No reliable data were available from a repeated dose toxicity study with ethylene carbonate via the dermal route. However, as the substance is rapidly metabolised to ethylene glycol after oral exposure (Hanley et al., 1989), reliable data from that metabolite are used for risk characterization of ethylene carbonate after oral ingestion (further information on the justification of the proposed read-across can be found in Section 13).

Therefore, the NOAEL of a chronic oral toxicity study in rats with ethylene glycol, set at 150 mg/kg bw/day is selected to derive the DNEL long-term systemic effects via the dermal route. Considering the higher molecular mass of ethylene carbonate in contrast to ethylene glycol (88.06 vs 62.07 g/mol), a NOAEL of 150 mg/kg bw/day of ethylene glycol corresponds to 212.9 mg/kg bw/day for ethylene carbonate. No additional factor should be applied for route-to-route extrapolation (it is assumed that dermal absorption will not be higher than oral absorption).

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point
AF for differences in duration of exposure:
1
Justification:
chronic study (1 year, oral, feed)
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainities
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
92.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

No reliable data were available from a repeated dose toxicity study with ethylene carbonate via the inhalation route. However, as the substance is rapidly metabolised after oral exposure to ethylene carbonate (Hanley et al., 1989), reliable data from that metabolite are used for the risk characterization of ethylene carbonate (further information on the justification of the proposed read-across can be found in Section 13). Therefore, the NOAEL of a chronic oral toxicity study in rats with ethylene glycol, set at 150 mg/kg bw/day as nephrotoxicity occurred at 300 and 400 mg/kg bw/day (Corley et al., 2008), is selected to derive the DNEL long-term systemic effects via the inhalation route for the general population as it is the most sensitive endpoint/lowest NOAEL value. Considering the higher molecular mass of ethylene carbonate in contrast to ethylene glycol (88.06 vs 62.07 g/mol), a NOAEL of 150 mg/kg bw/day of ethylene glycol corresponds to 212.9 mg/kg bw/day for ethylene carbonate. This recalculated NOAEL is used to derive the DNEL long-term systemic effects via the inhalation route for the general population.

For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point is 92.6 mg/m³ (= 212.9 mg/kg bw/day x 1/1.15 mg/m³ x 0.5). The NOAEL needed to be divided by 2 as the bioavailability via the inhalation route is considered as 100% while for oral exposure this is only 50%.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point
AF for differences in duration of exposure:
1
Justification:
chronic study (1 year, oral, feed)
AF for interspecies differences (allometric scaling):
1
Justification:
no value as it is included in the route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
212.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No reliable data were available from a repeated dose toxicity study with ethylene carbonate via the dermal route. However, as the substance is rapidly metabolised after oral exposure to ethylene glycol (Hanley et al., 1989), reliable data from that metabolite are used for risk characterization of ethylene carbonate after oral ingestion (further information on the justification of the proposed read-across can be found in Section 13). Therefore, the NOAEL of a chronic oral toxicity study in rats with ethylene glycol, set at 150 mg/kg bw/day is selected to derive the DNEL long-term systemic effects via the dermal route. Considering the higher molecular mass of ethylene carbonate in contrast to ethylene glycol (88.06 vs 62.07 g/mol), a NOAEL of 150 mg/kg bw/day of ethylene glycol corresponds to 212.9 mg/kg bw/day for ethylene carbonate. No additional factor should be applied for route-to-route extrapolation (it is assumed that dermal absorption will not be higher than oral absorption).

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point
AF for differences in duration of exposure:
1
Justification:
chronic study (1 year, oral, feed)
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
212.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No reliable data were available from a repeated dose toxicity study with ethylene carbonate via the oral route. However, as the substance is rapidly metabolised to ethylene glycol after oral exposure (Hanley, 1989), reliable data from that metabolite are used for risk characterization of ethylene carbonate after oral ingestion (further information on the justification of the proposed read-across can be found in Section 13). Therefore, the NOAEL of a chronic oral toxicity study in rats with ethylene glycol, set at 150 mg/kg bw/day is selected to derive the DNEL long-term systemic effects via the dermal route. Considering the higher molecular mass of ethylene carbonate in contrast to ethylene glycol (88.06 vs 62.07 g/mol), a NOAEL of 150 mg/kg bw/day of ethylene glycol corresponds to 212.9 mg/kg bw/day for ethylene carbonate.

AF for dose response relationship:
1
Justification:
NOAEL is used as starting point
AF for differences in duration of exposure:
1
Justification:
chronic study (1 year, oral, feed)
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
no remaining uncertainities
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population