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
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
420 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
840 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
1

Workers - Hazard via dermal 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

In 1999 the German MAK commission determined a scientific OEL for n-propyl acetate and iso-propyl acetate of 100 ppm (420 mg/m3), 8 hours of exposure.

Regarding the occupational situation, the critical toxic effect of exposure to propyl acetates is considered the irritative effect on the eyes and the mucosa of the upper respiratory tract. There is only one short term study with probands available for the determination of the treshold level for each isomer. Conformly, slight irritation effects were observed in both studies at 200 mL/m3. This study does not meet todays methodological standards but was the only one which was available. Therefore, the MAK value is assessed to be 100 mL/m3. This value is supported by the fact, that in other alkyl acetates the strength of irritation is increasing with chain length. Accordingly, the MAK value for the shorter-chained ethyl acetate is 400 mL/m3 and for the longer-chained 1-butyl acetate 100 mL/m3, respectively. There are no systemic toxic effects expected, even on reproduction and development, if the MAK value will be adhered to (based on data of metabolites and analogous substances, i.e. acetic acid and 1- or 2-propanol, respectively). Therefore the inhalation limit value of 420 mg/m3 for eight hours of exposure was adopted as DNEL for long-term exposure (local effects). For short term exposure, the limit value is set at 840 mg/m3 in German regulation. This value was adopted as short term DNEL for local effects. No hazard for systemic effects was identified.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
149 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
2.814
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
298 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Overall assessment factor (AF):
2.814

Local effects

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

General Population - Hazard via dermal 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

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The DNEL long-term effects via inhalation for the general population was derived from the corresponding DNEL for workers as the relevant DNEL. Although no systemic effects have been observed in the available studies with propyl acetate, systemic DNELs for the consumer were derived as worst case. Effects were considered as depending on the exposure time of the substance to the target organ (mucosa of the eyes/ upper respiratory tract). Therefore, single assessment factors (AF) of 3 (extrapolation from 8 to 24 h exposition) and 1.4 (extrapolation from 5 to 7 days) are used. Additionally, a lower mean respiration volume of the general population is considered with an AF of 0.67 (6.7/10 ) (6.7 m3 respiration volume/ "8h with no activity" divided by 10 m3 respiration volume/ "8h with light activity"). This leads to a total assessment factor of ca. 2.814. An additional safety factor of 2 for intraspecies differences (worker (5) to consumer (10)) was not deemed necessary as the worker DNEL is based on local effects where no significant differences between workers and consumers are expected and in addition no systemic effects were observed in the available studies with propylacetate. The long-term worker DNEL of 420 mg/m3 therefore has to be divded by 2.814 leading to a long-term DNEL for the general population of ca. 149 mg/m3 for systemic effects. The short term DNEL for systemic effects was derived from the respective short-term DNEL for workers by applying the same total assessment factor of ca. 2.814 leading to a short-term DNEL for the general population of 298 mg/m3 (systemic effects).

Local effects (e.g. respiratory tract irritation) are a local point of contact effect dependent on the air concentration thus the available local DNELs for workers could directly be used as consumer DNELs. In order to achieve an additional level of safety, a safety factor of 2 was used on the local worker DNELs to derive the local consumer DNELs. Thus, for risk assessment, a long-term local DNEL for consumers of 210 mg/m3 and a short-term local DNEL for consumers of 420 mg/m3 is proposed.

For dermal and oral long-term systemic effects, no hazard was identified based on the available data for propyl acetate. Nevertheless, the respective DNELs of the read across substance n-butyl acetate were used for risk assessment as a worst case (consumer, long-term systemic dermal route: 6 mg/kg and consumer, long-term systemic oral route: 2 mg/kg).