Registration Dossier
Registration Dossier
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EC number: 220-778-7 | CAS number: 2896-70-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132.24 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For workers: corrected inhalatory N(L)OAEC =oral N(L)OAEL x (1/sRVrat) x (ABS oral -rat/ABS inh -human) x (sRVhuman /wRV)
= N(L)OAEC = 150 mg/kg bw/day x (1/0.38 m3/kg/d) x (50%/100%) x(6.7 m3 / 10 m3) = 132 mg.m3
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was used to derive the DNEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating between subacute and chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- None required. Taken into account during correction of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for the tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.12 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:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For workers: corrected inhalatory N(L)OAEC =oral N(L)OAEL x (1/sRVrat 4 hours) x (ABS oral -rat/ABS inh -human) x (sRVhuman /wRV)
= N(L)OAEC = 150 mg/kg bw/day x (1/0.19 m3/kg/d) x (50%/100%) x(6.7 m3 / 10 m3) = 264 mg.m3
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was used to derive the DNEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- None required. Taken into account during correction of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- database adequate for the tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
dermal NOAEL = Oral NOAEL x (oral absorption/dermal absorption) =
150 mg/kg bw/day x (100% / 100%) =150 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was used to derive the DNEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating between subacute and chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating between rat and man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for the tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
dermal NOAEL = Oral NOAEL x (oral absorption/dermal absorption) =
150 mg/kg bw/day x (100% / 100%) =150 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was used to derive the DNEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating between rat and man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for the tonnage
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
As a result of the exposure scenarios derived for the chemical safety assessment, no exposure to the general population is expected.
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.
