Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-990-3 | CAS number: 903-19-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.165 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 12.34 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 rat / 5 exposure worker) = 10 mg/kg bw/day*(1 / 0.38 m³/kg bw/day)*(0.5 / 1)*0.67*1.4 = 12.34 mg/m³.
It is assumed that oral absorption rate is 50% of that of inhalation absorption.
ABSoral-rat = oral absorption rate in rats, ABSinh-human = inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default value: The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default value for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default value (no allometric scaling needs to be applied for route-to-route extrapolation from the oral to the inhalation route).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default value.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default value for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL calculation is based on a GLP guideline study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.47 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAELcorr = NOAELoral * (ABSoral-rat / ABSdermal-human) * (7 day exposure rat / 5 days exposure worker) = 10 mg/kg bw/day * (100%/10%) * 1.4 = 140 mg/kg bw/day.
ABSoral-rat = oral absorption rate in rats, ABSdermal-human = dermal absorption rate in humans.
The test substance has a logPow of 5.814 and a calculated flux of 0.00394 µg/cm²/h (DERMWIN). According to Kroes et al. (Food Chem Toxicol 45, 2533–62, 2007) a dermal absorption rate of 10% can be assumed if the flux is below 0.1 µg/cm²/h. It is therefore assumed that the dermal absorption rate is 10% of the oral absorption rate.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default value: The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default value for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default value for the rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default value.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default value for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL calculation is based on a GLP guideline 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
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:
- 0.029 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral * (1 / 1.15 m³/kg bw/day) * (ABSoral-ra t/ ABSinh-human) = 10 mg/kg bw/day * (1 / 1.15 m³/kg bw/day) * (0.5 / 1) * = 4.35 mg/m³.
It is assumed that oral absorption rate is 50% of that of inhalation absorption.
ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default value: The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default value for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default value (no allometric scaling needs to be applied for route-to-route extrapolation from the oral to the inhalation route).
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default value.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default value for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL calculation is based on a GLP guideline study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAELcorr = NOAELoral * (ABSoral-rat / ABSdermal-human) = 10 mg/kg bw/day * (100% / 10%) = 100 mg/kg bw/day.
ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
The test substance has a logPow of 5.814 and a calculated flux of 0.00394 µg/cm²/h (DERMWIN). According to Kroes et al. (Food Chem Toxicol 45, 2533–62, 2007) a dermal absorption rate of 10% can be assumed if the flux is below 0.1 µg/cm²/h. It is therefore assumed that the dermal absorption rate is 10% of the oral absorption rate.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default value: The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default value for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default value for the rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default value
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default value for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL calculation is based on a GLP guideline 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.017 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
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation required.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default value: The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default value for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default value for the rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default value
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default value for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- DNEL calculation is based on a GLP guideline study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
