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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
