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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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EC number: 200-562-9 | CAS number: 63-68-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 110.4 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):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 627 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 104 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL 627 mg/kg bw/day from a subchronic oral study in rats. Route-to-route extrapolation: Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 626 * 100/100 = 626 mg/kg bw . Corrected inhalatory NOAEC = 626 * 1/0.38 * 6.7 m3/10 m3 = 1104 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling already respected for the modification of the dose descriptor starting point
- AF for other interspecies differences:
- 1
- Justification:
- AF not used, other differences in toxicological effects are not expected
- AF for intraspecies differences:
- 5
- Justification:
- AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- quality of the database is good
- AF for remaining uncertainties:
- 1
- Justification:
- AF not used, remaining uncertainties in toxicological effects are not expected
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:
- 156.5 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 626 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 260 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL 626 mg/kg bw/day from a subchronic oral study in rats. Route-to-route extrapolation: Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 626 * 100/10 = 6260 mg/kg bw.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat – human
- AF for other interspecies differences:
- 1
- Justification:
- AF not used, other interspecies differences in toxicological effects are not expected
- AF for intraspecies differences:
- 5
- Justification:
- AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- quality of the database is good
- AF for remaining uncertainties:
- 1
- Justification:
- AF not used, remaining uncertainties in toxicological effects are not expected
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:
- no hazard identified
Additional information - workers
As an acute toxicity hazard leading to Classification and Labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur.
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 100%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100%
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 27.2 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 626 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 544.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL 626 mg/kg bw/day from a subchronic oral study in rats. Route-to-route extrapolation: Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 626 * 100/100 = 626 mg/kg bw. Corrected inhalatory NOAEC = 626 * 1/1.15 =544.35 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling respected for the modification of the dose descriptor starting point
- AF for other interspecies differences:
- 1
- Justification:
- AF not used, remaining differences in toxicological effects are not expected
- AF for intraspecies differences:
- 10
- Justification:
- Af for general population
- AF for the quality of the whole database:
- 1
- Justification:
- quality of the database is good
- AF for remaining uncertainties:
- 1
- Justification:
- AF not used, remaining uncertainties in toxicological effects are not expected
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:
- 78.25 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):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 626 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 260 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL 626 mg/kg bw/day from a subchronic oral study in rats. Route-to-route extrapolation: Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 626 * 100/10 = 6260 mg/kg bw.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat – human
- AF for other interspecies differences:
- 1
- Justification:
- AF not used, other interspecies differences in toxicological effects are not expected
- AF for intraspecies differences:
- 10
- Justification:
- AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- quality of the database is good
- AF for remaining uncertainties:
- 1
- Justification:
- AF not used, remaining uncertainties in toxicological effects are not expected
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:
- 7.8 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):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 626 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL 626 mg/kg bw/day from a subchronic oral study in rats.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- AF not used, other interspecies differences in toxicological effects are not expected
- AF for intraspecies differences:
- 10
- Justification:
- AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- quality of the database is good
- AF for remaining uncertainties:
- 1
- Justification:
- AF not used, remaining uncertainties in toxicological effects are not expected
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
As an acute toxicity hazard leading to Classification and Labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur.
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 100%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100%
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.
