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: 500-204-4 | CAS number: 68334-05-4
Toxicological information
Toxicological Summary
Currently viewing:
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22.77 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 569.2 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)) = 645.6 mg/kg bw/day*(1/0.38 m³/kg bw/day)*0.67*(0.5/1) = 569.2 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:
- The dose descriptor starting point is based on a NOAEC
- 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:
- AF not used for inhalation route
- 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
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 64.6 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 456 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (645.6 mg/kg bw/day)*(1/0.1) = 6456 mg/kg bw/day. It is assumed that the dermal absorption rate is 10% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. 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 DNEL required: short term exposure controlled by conditions for long-term
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 5.61 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 280.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr = NOAELoral*(1/1.15 m³/kg bw/day)*(ABSoral-rat/ABSinh-human) = 645.6 mg/kg bw/day*(1/1.15)*(0.5/1)= 280.7 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:
- The dose descriptor starting point is based on a NOAEC
- 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:
- AF not used for the inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the 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
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 32.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 456 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (645.6 mg/kg bw/day)*(1/0.1) = 6456 mg/kg bw/day. It is assumed that the dermal absorption rate is 10% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. 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:
- 10
- Justification:
- Default AF for the 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 DNEL required: short term exposure controlled by conditions for long-term
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.23 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 645.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (645.6 mg/kg bw/day)*(1/1) = 645.6 mg/kg bw/day. It is assumed that the oral absorption rate is 100% as a worst case assessment.
- 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 the 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
- Route of original study:
- Oral
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.
