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Registration Dossier
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EC number: 203-398-6 | CAS number: 106-44-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.47 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 61.71 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected NOAEC = 61.71 mg/m³ (50 x 1/0,38 x7/5 x50/100 x 6.7/10).
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from subchronic study to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required: already accounted for in route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- default value (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.35 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 70 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
70 mg/kg (50 x 7/5)
Exposure animals/exposure worker [day].
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 5
- Justification:
- Default value (ECHA) for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Systemic toxicity (long-term):
Starting point: NOAEL 50 mg/kg; OECD TG 408
Once daily (gavage) for 13 consecutive weeks.
ECHA REACH Guidance factors are used for derivation of the DNELs
Systemic toxicity (short-term):
Short-term toxicity is derived from long-term toxicity (factor 5).
Local toxicity (long- and short-term):
Classification: Skin Corr. 1B; H314 -> medium hazard band (ECHA REACH Guidance).
Classification: H314: Causes severe skin burns and eye damage -> medium hazard band (ECHA REACH Guidance).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.43 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.74 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Corrected NOAEL = 21.74 mg/m³ (50 x 1/1,15 x 50/100)
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- extrapolation from a sub-chronic study to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required: already accounted for in route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- default value
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.15 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 10
- Justification:
- Default value (ECHA) for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value (ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 10
- Justification:
- Default value (ECHA) for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Systemic toxicity (long-term):
Starting point: NOAEL 50 mg/kg; OECD TG 408
Once daily (gavage) for 13 consecutive weeks.
ECHA REACH Guidance factors are used for derivation of the DNELs
Systemic toxicity (short-term):
Short-term toxicity is derived from long-term toxicity (factor 5).
Local toxicity (long- and short-term):
Classification: Skin Corr. 1B; H314 -> medium hazard band (ECHA REACH Guidance).
Classification: H314: Causes severe skin burns and eye damage -> medium hazard band (ECHA REACH Guidance).
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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