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
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