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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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