Registration Dossier
Registration Dossier
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EC number: 211-463-5 | CAS number: 646-06-0
Toxicological Summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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