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EC number: 263-174-9 | CAS number: 61791-42-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.81 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 370.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h))*(7 days exposure/ 5 days exposure) = 300 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(1/2)*0.67*1.4 = 370.26 mg/m³.
By default, it is assumed that the oral absorption rate is 50% of that of inhalation absorption.
ABS(oral/rat) = oral absorption rate in rats, ABS(inh./human) = inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences were taken into account for the conversion of the rat oral NOAEL into a corrected inhalatory NOAEC considering allometric scaling for the respiratory volumes (modification of the dose descriptor starting point). Thus, no additional AF is applicable.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 4.2 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 420 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL*ABS(oral)/ABS(dermal) = 300 mg/kg bw/day *(1/1) * 1.4 = 420 mg/kg bw/day. It is assumed that oral and dermal absorption rates are equal.
ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- low 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:
- 2.61 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):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 300 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.43 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/1.15 m³/kg bw/day (24h)) *(ABSoral-rat/ABSinh-human) = 300 mg/kg bw/day*(1/1.15 m³/kg bw/day)*(1/2) = 130.43 mg/m³.
By default, it is assumed that the oral absorption rate is 50% of that of inhalation absorption.
ABS(oral/rat) = oral absorption rate in rats, ABS(inh./human) = inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences were taken into account for the conversion of the rat oral NOAEL into a corrected inhalatory NOAEC considering allometric scaling for the respiratory volumes (modification of the dose descriptor starting point). Thus, no additional AF is applicable.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 1.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = oral NOAEL*ABS(oral, rat)/ABS(dermal, human) = 300 mg/kg bw/day *(1/1) = 300 mg/kg bw/day.
It is assumed that oral and dermal absorption rates are equal.
ABSoral,rat = oral absorption rate in rats, ABSdermal,human = dermal absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Justification: The DNEL is based on a subchronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- 1.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There is no route to route extrapolation necessary.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is based on a subchronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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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