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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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.
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.
