Registration Dossier
Registration Dossier
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EC number: 261-665-2 | CAS number: 59219-71-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.158 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 528.95 mg/m³
- Explanation for the modification of the dose descriptor starting point:
dose descriptor calculation =
NOAEL oral * (1/SRV) * sRV*ABS = 600*(1/0.38)*0.67*0.5 = 528.95 mg/m3
Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)- Justification:
- default value
- Justification:
- for extrapolation subchronic to chronic
- Justification:
- default value systemic effect
- Justification:
- default value systemic effect
- Justification:
- default value for worker
- Justification:
- reliability 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
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:
- 5.217 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 260.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
dose descriptor calculation =
NOAEL oral * (1/SRV) *ABS = 600*1/1.15*0.5 = 260.87 mg/m3
Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)- Justification:
- default value
- Justification:
- for extrapolation subchronic to chronic
- Justification:
- default value systemic effect
- Justification:
- default value systemic effect
- Justification:
- default value general population
- Justification:
- reliability 2
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Justification:
- default value
- Justification:
- for extrapolation from subchronic to chronic
- Justification:
- default value
- Justification:
- default value systemic effect
- Justification:
- default value general population
- Justification:
- reliablity 1
- Justification:
- not concerned
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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