Registration Dossier
Registration Dossier
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EC number: 209-683-1 | CAS number: 590-46-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 177 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
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
NOAEC= ((7567 /4) x 70) /10 = 13242 mg/m^3
7567 mg/kg bw/day is NOAEC on rat; 4 = allometric scaling factor rat; 70 kg/bw= standard human body weight; 10 m^3/person= default human breathing volume for workers in 8 h.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 6
- Justification:
- from subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling needed because the starting point (NOAEC) has just been corrected for the human evaluation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- human worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and human is assumed
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:
- 252 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
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
10% adsorption for dermal route compared to oral route is assumed. NOAEL is corrected for route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 6
- Justification:
- from subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- human worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- high 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:
- 44 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
NOAEC= ((7567 /4) x 70) /20 = 6621 mg/m^3
7567 mg/kg bw/day is NOAEC on rat; 4 = allometric scaling factor rat; 70 kg/bw= standard human body weight; 20 m^3/person= default human breathing volume for general population 24h.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 6
- Justification:
- from subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling needed because the starting point (NOAEC) has just been corrected for the human evaluation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for inhalative route for animal and human is assumed
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:
- 126 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
10% adsorption for dermal route compared to oral route is assumed. NOAEL is corrected for route to route extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 6
- Justification:
- from subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 12.6 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
subacute NOAEC on rat = 7567 mg/kg bw/day, no modification necessary
- AF for dose response relationship:
- 1
- Justification:
- No scaling needed
- AF for differences in duration of exposure:
- 6
- Justification:
- from subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicocinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- 100% adsorption for oral route for animal and human is assumed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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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