Registration Dossier
Registration Dossier
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EC number: 220-941-2 | CAS number: 2943-75-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.6 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:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As a worst case the DNEL for systemic effects via the inhalation route is determined on the basis of route-to-route extrapolation from the oral NOAEL of 250 mg/kg bw/day. The following correction was made to the NOAEL(oral) to derive the NOAEC(inhalation): Correction for respiratory rate and volume (rat to human worker): (6.7 m³/d/10 m³/d)*(1/0.38 m³/kg) (default). Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [250 mg/kg/day*(6.7 m³/d /10 m³/d)*(1/0.38 m³/kg)] = 441 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL has been determined.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
- 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:
- 2.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction to the NOAEL is required.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL has been determined.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for oral rat to dermal human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 4.3 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL(oral) to derive the NOAEC(inhalation): Correction for respiratory rate and volume (rat to human consumer): (1/1.15) (default) Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [250 mg/kg/day*(1/1.15 m³/kg)] = 217.4 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted in accordance with appropriate OECD test guidelines and in compliance with GLP.
- 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:
- 1.25 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction to the NOAEL is required.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for oral rat to dermal human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted in accordance with appropriate OECD test guidelines and in compliance with GLP.
- 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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction to the NOAEL is required.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default for rat oral to human oral route of exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to appropriate OECD test guidelines and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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.
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.
