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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
903 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
453.757 mg/m³
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation necessary, as route in original study is via inhalation.


Corrected inhalation NOAEC = starting point NOAEC x 0.75 x 0.67 = 453.7575 mg/m3


with


0.75 for time scaling (When NOAEC is available from a rat 6 h/d inhalation study: factor of 0,75 (6 h/8 h) for workers)


0.67 for Default physiological parameters (Human standard respiratory volume (sRV) for 8 h exposure: 6,7 m3; Worker respiratory volume light activity (wRV) for 8 h exposure: 10 m3) 

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scaling foreseen in case of inhalation toxicity studies
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
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:
2.62 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
903 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
261.87 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected dermal NOAEC = starting point NOAEC x 0.29 = 261.87 mg/kg bw/d


with 0,29 = rat sRV for 6 h exposure


 

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
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:
medium hazard (no threshold derived)

Additional information - workers

In the absence of classification for systemic and local effects after acute inhalation exposure and local effects after dermal exposure to 1,3 -Dioxolane for acute toxicity, no acute DNEL's are considered applicable.

In the absence of local effects after repeated exposure to 1,3 -Dioxolane, no long-term DNELs for local effects are considered applicable.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
903 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
225 mg/m³
Explanation for the modification of the dose descriptor starting point:

Corrected inhalation NOAEC = 900 mg/m3x 6/24 = 225 mg/m3

               With time scaling: rat (6h); general population (24h). Source: Guidance R8 from ECHA (v2.1; nov 2012)

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1.31 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
903 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
261.87 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected dermal NOAEL = 903 mg/m3x 0.29 = 261.87 mg/kg bw/d


               With time scaling: sRVrat for 6h exposure of 0.29 m3/kg/d

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1.31 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
903 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
216.87 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Corrected oral NOAEL = 903 mg/m3x 0.29 = 216.87 mg/m3


               With time scaling: sRVrat for 6h exposure of 0.29 m3/kg/d


 


 

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population