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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 451-160-7 | CAS number: 17913-76-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.7 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 617 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 700 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
DNELs based on NOAEL of 500 mg/kg bw/d obtained in the subchronic study/one generation with rats
Hazard conclusions for workers
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 24.7mg/m³
|
effect on fertility (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 7mg/kg bw/day
|
effect on fertility (Oral)
|
Correction factors:
Correction for differences in respiratory volume (workers): 2.63
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for light activity at work: 0.67
Correction for differences between human and experimental exposure conditions (workers): 1.4
Inhalation Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:25
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:100
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
DNELs based on NOAEL of 200 mg/kg bw/d obtained in the subchronic study with beagle dogs
Hazard conclusions for workers
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 28.9mg/m³
|
repeated dose toxicity (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 8mg/kg bw/day
|
repeated dose toxicity (Oral)
|
Correction factors:
Correction for differences in respiratory volume (workers): 7.69
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for light activity at work: 0.67
Correction for differences between human and experimental exposure conditions (workers): 1.4
Inhalation Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEC
Overall Assessment Factor:25
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEL
Overall Assessment Factor:35
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1.4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Similar DNELs were obtained with both starting points.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.35 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 218 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - 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:
- effect on fertility
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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:
- low hazard (no threshold derived)
Additional information - General Population
DNELs based on NOAEL of 500 mg/kg bw/d obtained in the subchronic study/one generation with rats
Hazard conclusions for the general population
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 4.35mg/m³
|
effect on fertility (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.5mg/kg bw/day
|
effect on fertility (Oral)
|
Oral
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.5mg/kg bw/day
|
effect on fertility (Oral)
|
Correction factors:
Correction for differences in respiratory volume (general population): 0.78
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for differences between human and experimental exposure conditions (general population): 1
Inhalation Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:50
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:200
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Oral Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:200
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
DNELs based on NOAEL of 200 mg/kg bw/d obtained in the subchronic study with beagle dogs
Hazard conclusions for the general population
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 5mg/m³
|
repeated dose toxicity (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.86mg/kg bw/day
|
repeated dose toxicity (Oral)
|
Oral
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.86mg/kg bw/day
|
repeated dose toxicity (Oral)
|
Correction factors:
Correction for differences in respiratory volume (general population): 2.5
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for differences between human and experimental exposure conditions (general population): 1
Inhalation Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEC
Overall Assessment Factor:50
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEL
Overall Assessment Factor:70
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1.4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Oral Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEL
Overall Assessment Factor:70
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1.4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Similar DNELs were obtained with both starting points.
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.
