Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
610 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
LOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
610 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
2
Dose descriptor:
LOAEC
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
102 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
102 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
1

Workers - Hazard for the eyes

Additional information - workers

No DNELs for acute exposure have been derived for ethyl 3-ethoxypropionate as this substance is not classified for acute toxicity by any route and no acute effects have been observed in the repeated exposure studies. Ethyl 3-ethoxypropionate did not show any adverse effects regarding sensitization, mutagenicity or reproductive toxicity. Therefore, no DNELs have been derived for these endpoints.

The critical effect observed in repeated dose studies was local irritation. As no significant systemic effects were observed, the DNEL derived based on the local effects are considered to be sufficiently protective for potential systemic effects.

Worker-DNEL long-term for the inhalation route:

The relevant dose-descriptor for long-term exposure via the inhalation route is the LOAEC for local irritation from the 90-day inhalation toxicity study in rats being 250 ppm. The only systemic effefct observed were slight decrease in body weight gain and slight changes in serum chemistry at the higher dose levels. The slight local irritation is considered to be the critical effect and the German MAK Commission (2007) has established a workplace exposure limit of 100 ppm (or 610 mg/m3) for ethyl 3-ethoxypropionate (EEP). This value is supported by the results of the 2-week inhalation studies and the developmental toxicity studies via the inhalation route suggesting that no irritation effects will occur at 100 ppm. No new information on EEP has become available that would lead to a different evaluation of the toxicological data or to a different conclusion on the critical dose descriptor. Therefore - according to the ECHA guidance documents – the OEL of 100 ppm can be used as the Worker-DNEL-long term for the inhalation route.

Worker-DNEL long-term for the dermal route:

No dose-descriptor for long-term exposure via the dermal route is available for EEP. The 90-day inhalation study in rats was selected as the most relevant study for determining the DNEL because of the relevance of the route for repeated exposure.The relevant dose-descriptor for long-term exposure via the dermal route is the worker-DNEL of 100 ppm established for EEP by the German MAK Commission based on the 90-day inhalation toxicity study in rats. The dose descriptor has been converted into a dermal dose of 102 mg/kg bw/day according to the guidance document (ECHA, Chapter R.8). No additional assessment factors have been applied for inter- and intra-species differences as the starting point was the worker-DNEL for inhalation exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
72.6 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
8
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
72.6 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
8
Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.2 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
8
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.2
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
8

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

No DNELs for acute exposure have been derived for ethyl 3-ethoxypropionate as this substance is not classified for acute toxicity by any route and no acute effects have been observed in the repeated exposure studies. Ethyl 3-ethoxypropionate did not show any adverse effects regarding sensitization, mutagenicity or reproductive toxicity. Therefore, no DNELs have been derived for these endpoints.

The critical effect observed in repeated dose studies was local irritation. As no significant systemic effects were observed, the DNEL derived based on the local effects are considered to be sufficiently protective for potential systemic effects.

General population-DNEL long-term for inhalation route:

For the DNEL calculation we have deviated from default approach as described in the ECHA guidance documents. The dose descriptor used was the worker-DNEL-long term for the inhalation route which was corrected for the differences in duration of exposure between worker and consumer (24 hours per day, 7 days per week) and the intra-species differenceresulting in a DNEL of 11.9 ppm.

General population-DNEL long-term for dermal route:

The 90-day inhalation study in rats was selected as the most relevant study for determining the DNEL because of the relevance of the route for repeated exposure. The relevant dose-descriptor for long-term exposure via the dermal route is the worker-DNEL of 100 ppm based on the 90-day inhalation toxicity studies in rats. The dose descriptor was corrected for the differences in duration of exposure between worker and consumer (24 hours per day, 7 days per week) and then converted into a dermal dose of 24.2 mg/kg bw/day according to the guidance document (ECHA, Chapter R.8). No additional assessment factors have been applied for inter- and intra-species differences as the starting point was the worker-DNEL for inhalation exposure.

General population-DNEL long-term for oral route:

The relevant dose-descriptor for long-term exposure via the oral route is the NOAEL of 1000 mg/kg bw/day from a 28-day oral gavage study in rats. To correct for exposure duration (5 to 7 days per week), inter- and intra-species differences and for differences in the duration of exposure (sub-acute to chronic) the default assessment factors as specified in the guidance document (Chapter R.8) have been used to calculate the DNEL of 1.2 mg/kg bw/day.