Registration Dossier
Registration Dossier
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EC number: 265-449-9 | CAS number: 65113-55-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.84 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):
- 6
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11.02 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation as the oral route is the only one available: oral NOAEL rat males (90 days) = 12.5 mg/kg/day. Then extrapolated NOEC by inhalation is calculated assuming that inhalation absorption is 100% and oral absorption is 50% (as a worst case according to the guidance) : NOAEC = (12.5/0.38) *(50%/100%) (6.7/10) = 11.02 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is NOAEL (ECETOC TRA 110)
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECETOC TRA 110)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not used for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- (ECETOC report 110)
- AF for intraspecies differences:
- 3
- Justification:
- Default factor of 3 for workers (ECETOC report 110)
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality of the overall database.
- AF for remaining uncertainties:
- 1
- Justification:
- REACH guidance
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:
- 2.6 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):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 62.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation needed as the oral route is the only one available: oral NOAEL rat (90 days) = 12.5 mg/kg/day.
The starting point is modified assuming a dermal absorption of 10% and an oral absorption of 50%: 12.5*(50%/10%) = 62.50 mg/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is NOAEL (ECETOC TRA 110)
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECETOC TRA 110)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factors when the species is rats (ECETOC TRA 110)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC Report 110
- AF for intraspecies differences:
- 3
- Justification:
- Default factor of 3 for workers (ECETOC report 110)
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality of the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- Reach Guidance
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:
- medium hazard (no threshold derived)
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:
- 0.54 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):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation as the oral route is the only one available: oral NOAEL rat males (90 days) = 12.5 mg/kg/day. Then, extrapolated NOEC by inhalation is calculated assuming that inhalation absorption is 100% and oral absorption is 50% (according to the guidance) : NOAEC = (12.5/1.15) *(50%/100%) = 5.43 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is NOAEL (ECETOC TRA 110)
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECETOC TRA 110)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not used for inhalation route
- AF for other interspecies differences:
- 5
- Justification:
- Default factor of 5 for general public (ECETOC report 110)
- AF for intraspecies differences:
- 1
- Justification:
- ECETOC report 110
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality of the overall database
- AF for remaining uncertainties:
- 1
- Justification:
- Reach guidance
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:
- 1.56 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 62.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation as the oral route is the only one available: oral NOAEL rat males (90 days) = 12.5 mg/kg/day.
Then extrapolated NOEL by dermal route is calculated assuming a dermal absorption of 10% and an oral absorption of 50%: NOAEL = 12.5*(50%/10%) = 62.5 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is NOAEL (ECETOC TRA 110)
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECETOC TRA 110)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factors when the species is rats (ECETOC TRA 110)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC report 110
- AF for intraspecies differences:
- 5
- Justification:
- Default factor of 5 for general population (ECETOC report 110)
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality of the overall database
- AF for remaining uncertainties:
- 1
- Justification:
- Reach guidance
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:
- 0.31 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 12.5 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is NOAEL (ECETOC TRA 110)
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic (ECETOC TRA 110)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factors when the species is rats (ECETOC TRA 110)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC report 110
- AF for intraspecies differences:
- 5
- Justification:
- Default factor of 5 for general public (ECETOC report 110)
- AF for the quality of the whole database:
- 1
- Justification:
- Reach guidance
- AF for remaining uncertainties:
- 1
- Justification:
- Reach guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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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