Registration Dossier
Registration Dossier
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EC number: 219-785-8 | CAS number: 2530-85-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 50 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (6 h/d to 8 h/d), Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 50*(6 h/ 8 h) *(6.7 m3/10 m3) = 25 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default (inhalation rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 50 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (8 hour) = 0.38 m3/kg bw. Correction for exposure duration: 6 h/8 h (6 hours exposure in rats to 8 hours exposure in workers). Therefore, the corrected NOAEL for repeat-dose systemic effects via the dermal route is: 50*(6/8)*0.38 = 14.3 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 50 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 12.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for exposure duration (6 h/d to 24 h/d). Therefore the corrected NOAEC for infrequent use repeated-dose systemic effects via the inhalation route is: 50*(6 h/ 24 h) = 12.5 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default for infrequent use DNEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 50 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14.38 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m3/kg bw. Correction for exposure duration: 6 h/24 h (6 hours exposure in rats to 24 hours exposure in general population). Therefore the corrected NOAEL for repeat-dose systemic effects via the dermal route is: 50*(6/24)*1.15 = 14.38 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default for infrequent use DNEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14.38 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhaled): Correction respiratory volume rat (24 hour) = 1.15 m3/kg bw. Correction for exposure duration: 6 h/24 h (6 hours exposure in rats to 24 hours exposure in general population). Correction for dosing frequency: 5 days/7 days. Therefore the corrected NOAEL for repeat-dose systemic effects via the oral route is: 50*(6/24)*1.15 = 14.38 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default for infrequent use DNEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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
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