Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 701-246-8 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 230 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL 1000 mg/kg/day (OECD 408 study); x [6.7/10 {light work ventilation rate}] x [1/0.38 {adjust for human inhalation rate from oral}] x [7/5 {days/week exposure}] x [0.5{correction for differences in bioavailability}] = 1230 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEL as dose descriptor in terms of ECHA R.8 Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECHA R.8 value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 Value)
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies worker (ECHA R.8 Value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification factor of 1.4 used to account for 7 days/week exposure in study to 5 days/week for worker conditions.
- AF for dose response relationship:
- 1
- Justification:
- ECHA R.8 guidance (starting point a NOAEL; oral to dermal)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA R.8 guidance (sub-chronic to chronic)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R.8 guidance. Allometric scaling required (rat to humans)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R.8 guidance (intraspecies worker)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable guideline studies available
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL 1000 mg/kg/day (OECD 408 study); x [1/1.15 {respiratory volume SRV}] x [0.5{correction for differences in bioavailability}] = 435 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEL as dose descriptor in terms of ECHA R.8 Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECHA R.8 value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 Value)
- AF for intraspecies differences:
- 10
- Justification:
- Intraspecies general population (ECHA R.8 Value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not required
- AF for dose response relationship:
- 1
- Justification:
- Standard for NOAEL as dose descriptor in terms of ECHA R.8 guidance.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECHA R.8 guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human (ECHA R.8 guidance)
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for intraspecies differences:
- 10
- Justification:
- Intraspecies general population (ECHA R.8 value)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- low hazard (no threshold derived)
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:
- no hazard identified
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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