Registration Dossier
Registration Dossier
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EC number: 204-317-7 | CAS number: 119-36-8
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.87 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 123 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
sRVrat: 0,38 m3/kg bw
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSinh-human: 100 %
sRVhuman: 6,7 m3/kg bw
wRV: 10 m3/person
Correction for differences between human and experimental exposure conditions (EXPCOND): 1,4 (5/7 d/wk) - AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is from a chronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling factor: not applicable (already included during the route-to-route extrapolation)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for other remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point from a reliable chronic data
- AF for remaining uncertainties:
- 1
- Justification:
- not applicable
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:
- 2.8 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSder-human: 50 % (in accordance with SCCS 2021)
Correction for differences between human and experimental exposure conditions (EXPCOND): 1,4 (5/7 d/wk) - AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is from a chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point from a reliable chronic data
- AF for remaining uncertainties:
- 1
- Justification:
- not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.74 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:
- 43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
sRVrat: 1,15 m3/kg bw
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSinh-human: 100 %- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is from a chronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling factor: not applicable (already included during the route-to-route extrapolation)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for other remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point from a reliable chronic data
- AF for remaining uncertainties:
- 1
- Justification:
- not applicable
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 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
oral NOAEL: 50 mg/kg bw/d (chronic 2-year study in rats by oral route by Webb 1963, see SEV conclusion 2021)
ABSoral-rat: 100 % (in accordance with SEV conclusions 2021)
ABSder-human: 50 % (in accordance with SCCS 2021)- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is from a chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point from a reliable chronic data
- AF for remaining uncertainties:
- 1
- Justification:
- not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
no modification applied.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- The starting point is from a chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting point from a reliable chronic data
- AF for remaining uncertainties:
- 1
- Justification:
- not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.
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