Registration Dossier
Registration Dossier
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EC number: 219-834-3 | CAS number: 2549-51-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.31 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
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3.94 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As the NOAEL was obtained on rats using the oral route, it must be corrected for an inhalation exposure of workers, taking into account that workers are considered to be working 8h/d, with inhalative volumes for 8h/d defined in the ECHA Guidance at 6.7m3 for base level activity and 10m3 for light activity.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalation-human))) * (sRV(human) / wRV)
Where ABS = Absorption, sRV = standard Respiratory Volume, and wRV = worker Respiratory Volume. Absorptions by inhalation and oral route are not known, therefore it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalation-human))) * (sRV(human) / wRV)
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * 0.5 * (sRV(human) / wRV)
Corrected NOAEC(inhalation) = 4.48 mg/kg bw * (1 / 0.38m3/kg) * 0.5 * (6.7m3 / 10m3)
Corrected NOAEC(inhalation) = 3.94 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.078 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):
- 25
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.95 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As the NOAEL was obtained on rats using the oral route, it must be corrected for an inhalation exposure of the general population, taking into account that the general population is considered as being exposed 24h/d. A sRV(rat) of 1.15m3/kg is used in order to consider this 24h/d exposure. Absorptions by inhalation and oral route are not known, therefore it was considered that oral absorption in the rat was 50% less effective than the human absorption by inhalation in accordance with ECHA Guidance.
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * ((ABS(oral-rat) / ABS(inhalationhuman)))
Corrected NOAEC(inhalation) = NOAEL(oral-rat) * (1 / sRV(rat)) * 0.5
Corrected NOAEC(inhalation) = 4.48 mg/kg bw * (1 / 1.15m3/kg) * 0.5
Corrected NOAEC(inhalation) = 1.95 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 1
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.045 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):
- 100
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEL
- Value:
- 4.48 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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