Registration Dossier
Registration Dossier
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EC number: 606-790-9 | CAS number: 215247-95-3
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:
- 49 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 36
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The corrected inhalatory NOAEC is obtained by multiplying (allometric scaling) the NOAEL with 1/0.38 m³/kg/day * 6.7 m³ / 10 m³ as 1763 mg/m³ .
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- chronic to subacute extrabolation according to guidance
- AF for interspecies differences (allometric scaling):
- 3
- Justification:
- based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
- AF for other interspecies differences:
- 1
- Justification:
- based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2
- Justification:
- see explanation below
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
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:
- 42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
see explanation below
- AF for dose response relationship:
- 1
- Justification:
- see explanation below
- AF for differences in duration of exposure:
- 2
- Justification:
- see explanation below
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see explanation below
- AF for other interspecies differences:
- 1
- Justification:
- see explanation below1000
- AF for intraspecies differences:
- 3
- Justification:
- see explanation below
- AF for the quality of the whole database:
- 1
- Justification:
- see explanation below
- AF for remaining uncertainties:
- 1
- Justification:
- see explanation below
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- See explanation below
- AF for differences in duration of exposure:
- 2
- Justification:
- See explanation below
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- See explanation below
- AF for other interspecies differences:
- 1
- Justification:
- See explanation below
- AF for intraspecies differences:
- 5
- Justification:
- See explanation below
- AF for the quality of the whole database:
- 1
- Justification:
- See explanation below
- AF for remaining uncertainties:
- 1
- Justification:
- See explanation below
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:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See explanation below
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- See explanation below
- AF for differences in duration of exposure:
- 2
- Justification:
- See explanation below
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- See explanation below
- AF for other interspecies differences:
- 1
- Justification:
- See explanation below
- AF for intraspecies differences:
- 5
- Justification:
- See explanation below
- AF for the quality of the whole database:
- 1
- Justification:
- See explanation below
- AF for remaining uncertainties:
- 1
- Justification:
- See explanation below
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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