Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 500-429-8 | CAS number: 159034-96-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.603 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):
- 225
- Dose descriptor starting point:
- LOAEL
- Value:
- 110 mg/kg bw/day
- Value:
- 136 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In a 28 day repeated does oral toxicity study, NOAEL could not be determined and the dose of 110 mg/kg was considered proximal to LOAEL, and no other descriptors available, hence LOAEL=110 mg/kg is used for the derivation of the DNEL.
- AF for dose response relationship:
- 3
- Justification:
- The value of 3 is the default for dose descriptor LOAEC(L).
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study (28d).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The default value 4 for rat is not applicable as respiratory rates depend directly on caloric demand, hence value 1 is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 5
- Justification:
- The default value is 5 for works according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
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:
- 0.171 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):
- 900
- Dose descriptor starting point:
- LOAEL
- Value:
- 110 mg/kg bw/day
- Value:
- 154 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a 28 day repeated does oral toxicity study, NOAEL could not be determined and the dose of 110 mg/kg was considered proximal to LOAEL, and no other descriptors available, hence LOAEL=110 mg/kg is used for the derivation of the DNEL.
- AF for dose response relationship:
- 3
- Justification:
- The value of 3 is default for dose descriptor LOAEC(L).
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study (28d).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default value is 4 for study animal rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 5
- Justification:
- The default value is 5 for works according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
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:
- 0.106 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):
- 450
- Dose descriptor starting point:
- LOAEL
- Value:
- 110 mg/kg bw/day
- Value:
- 47.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In a 28 day repeated does oral toxicity study, NOAEL could not be determined and the dose of 110 mg/kg was considered proximal to LOAEL, and no other descriptors available, hence LOAEL=110 mg/kg is used for the derivation of the DNEL.
- AF for dose response relationship:
- 3
- Justification:
- The value of 3 is default for dose descriptor LOAEC(L).
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study (28d).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The default value 4 for rat is not applicable as respiratory rates depend directly on caloric demand, hence value 1 is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 10
- Justification:
- The default value is 10 for general population according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
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:
- 61.1 µg/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):
- 1 800
- Dose descriptor starting point:
- LOAEL
- Value:
- 110 mg/kg bw/day
- Value:
- 110 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a 28 day repeated does oral toxicity study, NOAEL could not be determined and the dose of 110 mg/kg was considered proximal to LOAEL, and no other descriptors available, hence LOAEL=110 mg/kg is used for the derivation of the DNEL.
- AF for dose response relationship:
- 3
- Justification:
- The value of 3 is default for dose descriptor LOAEC(L).
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study (28d).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default value is 4 for study animal rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 10
- Justification:
- The default value is 10 for general population according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
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:
- 61.1 µg/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):
- 1 800
- Dose descriptor starting point:
- LOAEL
- Value:
- 110 mg/kg bw/day
- Value:
- 110 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a 28 day repeated does oral toxicity study, NOAEL could not be determined and the dose of 110 mg/kg was considered proximal to LOAEL, and no other descriptors available, hence LOAEL=110 mg/kg is used for the derivation of the DNEL.
- AF for dose response relationship:
- 3
- Justification:
- The value of 3 is default for dose descriptor LOAEC(L).
- AF for differences in duration of exposure:
- 6
- Justification:
- The value of 6 is default for sub-acute study (28d).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default value is 4 for study animal rats.
- AF for other interspecies differences:
- 2.5
- Justification:
- The value of 2.5 is default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
- AF for intraspecies differences:
- 10
- Justification:
- The default value is 10 for general population according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The default value is 1 for quality of whole database according to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.
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.
